ERC Application NHMRC Final

RRC APPLICATION FORM
RESEARCH PROTOCOL NUMBER: PR-10001

FOR OFFICE USE ONLY
RRC Approval: Yes / ERC Approval: Yes / AEEC Approval: Yes / External IRB Approval: Yes / Name of IRB: No No No Date: Date: Date: No Date:
Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in
Bangladesh
Short title (in 50 characters including space): Peer conselling infant feeding education program Theme: (Check all that apply) Nutrition Emerging and Re-emerging Infectious Diseases Population Dynamics Reproductive Health Vaccine Evaluation HIV/AIDS Environmental Health Key words: Peer counselling, Infant, Intervention, breastfeeding, complementary feeding, stunting Relevance of the Protocol: Health Services Child Health Clinical Case Management Social and Behavioral Sciences Gender Human Rights Others (please specify___________________)
Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 55% of child deaths and 11% of the total global disease burden. Inappropriate complementary feeding is an important predictor of poor growth and morbidity in infants and young children. The proposed research will evaluate an intervention to promote and sustain optimal feeding in children aged 0-24 months. This research builds on the prior experience of members of the research team with the use of peer counselling to improve feeding practices in infants aged 0-6 months. Risk factors of suboptimal breastfeeding and complementary feeding in Bangladesh will be taken into account when designing the peer counselling materials for improving infant and young child feeding. This study will help fill this evidence gap about effective interventions to improve infant and young child feeding and prevent childhood malnutrition in Bangladesh.
Centres Priority (as per Strategic Plan, to be imported from the attached Separate Word Sheet):
1.5. Strengthen child health and development interventions through research on effective child caring, stimulation and health-seeking practices in the homes. 3.3 Improving child feeding including increasing rates of exclusive breastfeeding and appropriate and adequate complementary feeding.
Programmes: Child Health Programme Nutrition Programme Programme on Infectious Diseases & Vaccine Science Poverty and Health Programme Health and Family Planning Systems Programme Principal Investigator (Should be a Centres staff) Dr. A.K.M. IQBAL KABIR Address (including e-mail address): Population Programme Reproductive Health Programme HIV/AIDS Programme Gender, Hunman Rights and Health Programme Others (please specify___________________)
DIVISION:
CSD HSID LSD PHSD
Scientist, ICDDR,B, Mohakhali, Dhaka-1212, Emailikabir@icddrb.org, 8860523-32(2312)
Principal Investigator(s): External Dr. Michael J Dibley, Associate Professor in International Public Health at the School of Public Health, the George Institute for International Health, University of Sydney. Email: mdibley@health.usyd.edu.au Co-Principal Investigator(s): Internal Dr. S. K. Roy, Senior, Scientist, ICDDR,B, Mohakhali, Dhaka-1212, Email-skroy@icddrb.org, 886052332(2313)
Co-Investigator(s): Internal: Dr. Anadil Alam, Research Investigator, HSID, ICDDR,B; e-mail: anadil@icddrb.org Co-Investigator(s): External: Seema Mihrshahi| Postdoctoral Research Fellow | Institute of Health and Biomedical Innovation Queensland University of Technology | 60 Musk Ave, Kelvin Grove, QLD, 4059, Australia t: +617 3138 6171| f: +617 3138 6030 | e: seema.mihrshahi@qut.edu.au | w: www.ihbi.qut.edu.au Co-Investigator(s): External (Please provide full official address including e-mail address and Gender)
Kingsley E. Agho, Research Fellow in biostatistics at the School of Medicine, University of Western Sydney, Australia. Email: K.Agho@uws.edu.au
Student Investigator(s): Internal (Centres staff):
Student Investigator(s): External: (Please provide full address of educational institution and Gender)
Collaborating Institute(s): Please Provide full address Institution # 1 Country Contact person Department (including Division, Centre, Unit) Institution (with official address) Directorate (in case of GoB i.e. DGHS) Ministry (in case of GoB) Australia Michael J. Dibley Associate Professor in International Public Health The University of Sydney, Room no-307 A, Edward Ford Building (A 27) NSW 2006, Australia
Institution # 2
Institution # 3 Country Contact person Department (including Division, Centre, Unit) Institution (with official address) Directorate (in case of GoB i.e. DGHS) Ministry (in case of GoB)
Note: If more than 3 collaborating institutions are involved in the research protocol, additional block(s) can be inserted to mention its/there particular(s).
Population: Inclusion of special groups (Check all that apply): Sex Male Female Age 0 4 years 5 10 years 11 17 years 18 64 years 65 + NOTE Pregnant Women Fetuses Prisoners Destitutes Service Providers Cognitively Impaired CSW Others (specify ) Animal
It is the policy of the Centre to include men, women, and children in all research projects involving human subjects unless a clear and compelling rationale and justification (e.g. gender specific or inappropriate with respect to the purpose of the research) is there. Justification should be provided in the `Sample Size section of the protocol in case inclusiveness of study participants is not proposed in the study. Project/study Site (Check all the apply): Dhaka Hospital Matlab Hospital Matlab DSS Area Matlab non-DSS Area Mirzapur Dhaka Community Chakaria Abhoynagar Mirsarai Patyia Other areas in Bangladesh Outside Bangladesh Name of Country: Multi Centre Trial (Name other countries involved):
Type of Study (Check all that apply): Case Control Study Community-based Trial/Intervention Program Project (Umbrella) Secondary Data Analysis Clinical Trial (Hospital/Clinic) Family Follow-up Study NOTE: Does the study meet the definition of clinical studies/trials Journal Editors (ICMJE)? Yes No Cross Sectional Survey Longitudinal Study (cohort or follow-up) Record Review Prophylactic Trial Surveillance/Monitoring Others: given by the International Committee of Medical
Please note that the ICMJE defined clinical trial as Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. If YES, after approval of the ERC, the PI should complete and send the relevant form to provide required information about the research protocol to the Committee Coordination Secretariat for registration of the study into websites, preferably at the https://register.clinicaltrials.gov/. It may please be noted that the PI would require to provide subsequent updates of the research protocol for updating protocol information in the website. Targeted Population (Check all that apply): No ethnic selection (Bangladeshi) Bangalee Tribal group Consent Process (Check all that apply): Written Oral None Bengali Language English Language Expatriates Immigrants Refugee
Proposed Sample Size: Sub-group (Name of subgroup (e.g. Men, Women) and Number Name (1) Intervention Group ( Women, boys & girls) (2) Control Group (Women, boys & girls) Number 975 975 (3) (4) Total sample size: 1950 a) Will the specimen be stored for future use? b) If yes, how long the specimens be preserved? _____ years. Yes No NA Yes No Name Number
c) Will consent be obtained from study participants for the specimen be stored for future, for unrelated use without further taking consent?
d) What types of tests will be carried out with the preserved samples? __________________________________________ ____________________________________________________________________________________________ e) Will the samples be shipped to other country(ies)? Yes No NA f) If yes, name of institution(s) and country(ies): ___________________________________________________________ g) Will the surplus/unused specimen be returned to the Centre? Yes No NA
h) Who will be the custodian of the specimen at the Centre and when shipped outside of the country(ies)?: _________________________________________________________ i) Who will be the owner(s) of the samples? : __________________________________________________________ Yes No NA
j) Has a MoU been made for the protocol covering the specimen collection, storage, use and ownership? k) If yes, please attach a copy.
Determination of Risk: Does the Research Involve (Check all that apply): Human exposure to radioactive agents? Fetal tissue or abortus? Human exposure to infectious agents? Investigational new device? Investigational new drug Existing data available via public archives/sources (specify: ) Pathological or diagnostic clinical specimen only Existing data available from Co-investigator Observation of public behaviour New treatment regime No No Is the information recorded in such a manner that study participants can be identified from information provided directly or through identifiers linked to the study participants? Does the research deal with sensitive aspects of the study participants behaviour; sexual behaviour, alcohol use or illegal conduct such as drug use?
Could the information recorded about the individual if it became known outside of the research:
Do you consider this research (Check one): Greater than minimal risk No more than minimal risk Only part of the diagnostic test Minimal Risk is the risk when the probability and magnitude of the anticipated harm or discomfort in participating in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical, psychological examinations or tests, e.g. the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as a part of routine physical examination. Yes/ No Is the proposal funded? If yes, sponsor Name: (1) (2) NHMRC
Yes/No/NA (if the proposal is already funded, mark NA) Is the proposal being submitted for funding? If yes, name of funding agency: (1) (2) Do any of the participating investigators and/or member(s) of their immediate families have an equity relationship (e.g. stockholder) with the sponsor of the project or manufacturer and/or owner of the test product or device to be studied or serve as a consultant to any of the above? IF YES, a written statement of disclosure to be submitted to the Centres Executive Director. Dates of Proposed Period of Support (Day, Month, Year - DD/MM/YY) Beginning Date : 01/01/2010 End Date : 31/12/2013 Years Year-1 Year-2 Year-3 Year-4 Year-5 Total Certification by the Principal Investigator I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept the responsibility for the scientific conduct of the project and to provide the required progress reports including updating protocol information in the SUCHONA (Form # 2) if a grant is awarded as a result of this application. Direct Cost 0 Indirect Cost 0 Cost Required for the Budget Period ($) Total Cost (AUD ) 256,3 25 261,3 25 227,2 00 167,6 38 0 912,4 88
___________
Signature of PI
__30-12-09__________
Date
Approval of the Project by the Division Director of the Applicant The above-mentioned project has been discussed and reviewed at the Division level as well by the external reviewers. The protocol has been revised according to the reviewers comments and is approved.
Dr. A.K.M. Iqbal Kabir (Acting )

Name of the Division Director Signature
30-12-09
Date of Approval
Table of Contents
RRC APPLICATION FORM...............................................................................................................1 Project Summary................................................................................................................................11 Description of the Research Project...................................................................................................13 Hypothesis to be Tested:................................................................................................................13 Specific Aims:................................................................................................................................13 Background of the Project including Preliminary Observations ..................................................14 Research Design and Methods.......................................................................................................18 Sample Size Calculation and Outcome (Primary and Secondary) Variable(s)..............................21 Facilities Available.........................................................................................................................22 Data Safety Monitoring Plan (DSMP)...........................................................................................29 Approval.........................................................................................................................................31 Training..........................................................................................................................................31 Pilot study.......................................................................................................................................31 Ethical Assurance for Protection of Human Rights.......................................................................34 Use of Animals...............................................................................................................................34 Literature Cited...............................................................................................................................34 Dissemination and Use of Findings................................................................................................35 Collaborative Arrangements...........................................................................................................35 Biography of the Investigators ..................................................................................................36 Postgraduate Training in Nutrition in Health and Disease, 1982, Dunn Nutrition Unit, Cambridge University and Institute for Child Health, University of London..................................................38 Biography of the Investigators...........................................................................................................39 Biography of the Investigators...........................................................................................................41 Biography of the Investigators ..........................................................................................................43 Biography of the Investigators .........................................................................................................45 Budget Justifications..........................................................................................................................46 PI: Will spent 25% of time and be responsible for overall design, defending the proposal at institutional review committees, coordination with relevant persons and departments, training of staff, monitoring of quality and progress, checking at least 5% data in the field, and in data analyses and report writing...............................................................................................................................46 Other Support.....................................................................................................................................48 Check-List..........................................................................................................................................49 Purpose of the research...................................................................................................................70 Why are we inviting you to participate in the study? ................................................................70 What is expected from the participants of the research study?..................................................70 Risk and benefits........................................................................................................................71 Privacy, anonymity and confidentiality......................................................................................71 We will keep all of your information strictly confidential, and none other than the staff of our study and the Ethical Review Committee of ICDDR,B that protects the interest of research participants will have an access to your information. If you wish we will inform you any results of your own.....................................................................................................................71 Future use of information...........................................................................................................71 MelYvi Dk:...............................................................................................................................73 Dbqbkxj `ki ga evsjv`ki wkì ga Acywi ecKZvi nvi cej| cixvq `Lv wMqQ h h_vh_ AvBIqvBwZGd viv 1/5 wk gZz nvi KgQ Ges Acyw `~ixKib iyZc~iY fywgKv ivL| 54% wk gZz Ges 11% wewfb aibi AmyLi cavb Kvib GB Acyw| 18 gvmi wk Lv`vfvm DbZ Kivi Rb eZgvb Kvb aibi civgk Kvhg wekl Ki mZx_ civgk Pvjy bB| civgk Kvhgi mydj Ges civgk `vbi Dchy mgq Avgvì `ki Acyw `~ixKib iyZc~iY fywgKv ivLe| Dbqbkxj `ki RbmsLv cwiKbvKvixì Rb GwU GKwU AZ AvKlbxq cwiKbv nZ cvi| Avkv Kiv hvq GB Melbv nZ cv djvdj cKvwkZ nj wkì
^vi Dci iZc~ib cfve dje| `wY Gwkqvi wkì Rb Rb^v I cyw welqK cwiKbvi Dbqb Kiv hve, hvi viv wkì ^vI DbwZZ ecK f~wgKv ivLe| .............................73 Avcwb hw` GB MelYv KvR AskMnb KiZ mZ nb Ze Avgiv AvcbvK Avcbvi Av_ mvgvwRK Aev, wki Rb eZgvb Zij I k Lvevii eev, k ev Zij Lvevi i Kivi mgq, `y`vbi Rb evZji eenvi mK wKQy ck Kie| Avgiv AviI RvbZ PvBe h cvwievwiK I cvovcwZkx v Avxq bq Ggb Kn AvcbvK beRvZKi Lv`vfvm mK Dc`k w`qQ Ges MZ 24 NUvq KZevi wkwU Lv` Mnb KiQ| Avgiv Avcbvi IRb I DPZv Ges Avcbvi wki IRb, `N, ga evi cwigvcGes 24 NUvq m h Lv` Mnb Ki Zv cwigvc Kie| GB cyiv cwqvwUi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne| Avgiv AvcbvK m^wjZ AvjvPbvZ AskMnb Kivi Rb Avgb hvbvwQ | GB AvjvPbvZ AskMnb Kivi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne|........................................................................................73 SzuwK Ges DcKvixZv:- ................................................................................................................73 Purpose of the research...................................................................................................................75 Why are we inviting you to participate in the study? ................................................................76 What is expected from the participants of the research study?..................................................76 Risk and benefits........................................................................................................................76 Privacy, anonymity and confidentiality......................................................................................76 We will keep all of your information strictly confidential, and none other than the staff of our study and the Ethical Review Committee of ICDDR,B that protects the interest of research participants will have an access to your information. If you wish we will inform you any results of your own.....................................................................................................................76 Future use of information...........................................................................................................76 MelYvi Dk:...............................................................................................................................78 Dbqbkxj `ki ga evsjv`ki wkì ga Acywi ecKZvi nvi cej| cixvq `Lv wMqQ h h_vh_ AvBIqvBwZGd viv 1/5 wk gZz nvi KgQ Ges Acyw `~ixKib iyZc~iY fywgKv ivL| 54% wk gZz Ges 11% wewfb aibi AmyLi cavb Kvib GB Acyw| 18 gvmi wk Lv`vfvm DbZ Kivi Rb eZgvb Kvb aibi civgk Kvhg wekl Ki mZx_ civgk Pvjy bB| civgk Kvhgi mydj Ges civgk `vbi Dchy mgq Avgvì `ki Acyw `~ixKib iyZc~iY fywgKv ivLe| Dbqbkxj `ki RbmsLv cwiKbvKvixì Rb GwU GKwU AZ AvKlbxq cwiKbv nZ cvi| Avkv Kiv hvq GB Melbv nZ cv djvdj cKvwkZ nj wkì ^vi Dci iZc~ib cfve dje| `wY Gwkqvi wkì Rb Rb^v I cyw welqK cwiKbvi Dbqb Kiv hve, hvi viv wkì ^vI DbwZZ ecK f~wgKv ivLe| .............................78 Avcwb hw` GB MelYv KvR AskMnb KiZ mZ nb Ze Avgiv AvcbvK Avcbvi Av_ mvgvwRK Aev, wki Rb eZgvb Zij I k Lvevii eev, k ev Zij Lvevi i Kivi mgq, `y`vbi Rb evZji eenvi mK wKQy ck Kie| Avgiv AviI RvbZ PvBe h cvwievwiK I cvovcwZkx v Avxq bq Ggb Kn AvcbvK beRvZKi Lv`vfvm mK Dc`k w`qQ Ges MZ 24 NUvq KZevi wkwU Lv` Mnb KiQ| Avgiv Avcbvi IRb I DPZv Ges Avcbvi wki IRb, `N, ga evi cwigvcGes 24 NUvq m h Lv` Mnb Ki Zv cwigvc Kie| GB cyiv cwqvwUi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne| Avgiv AvcbvK m^wjZ AvjvPbvZ AskMnb Kivi Rb Avgb hvbvwQ | GB AvjvPbvZ AskMnb Kivi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne|........................................................................................79 SzuwK Ges DcKvixZv:- ................................................................................................................79 Do you prepare the complementary food with oil for your child? /__/__/.....................................110
Check here if appendix is included
Project Summary
Briefly describe the hypothesis, objectives, and the relevant background of the project, and also the experimental design and research methods for achieving the objectives. This description will serve as a succinct and precise and accurate description of the proposed research is required. This summary should be stand alone, and be fully understandable and interpretable when removed from the main application.
Principal Investigator: Dr. A. K. M. Iqbal Kabir Research Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Total Budget AU$: 912,488 Beginning Date : January 2010 Ending Date: December 2013
Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries. The risk of child death is also related to the severity of malnutrition and progressively increases the more the childs growth deviates from WHO Growth Standard, e.g. children with height-for-age <-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean. Underweight in children for 18.7% of the global disabilityadjusted life years in children less than five years of age. Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations. An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. A recent study has conducted on pioneering research on this approach in Bangladesh.. The main aim of the study is to use a cluster RCT to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children. We will use a community-based CRCT to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery, to improve child feeding practices, child growth and reduce the prevalence of malnutrition in their children. This will result in two study groups. The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because we expect a likely high correlation between baseline and follow up outcome measures, thus making this approach the most efficient study design. Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 1950 mother-infant days (975 in each treatment group). The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. Using a similar approach to recruitment, a cohort of mother-infant dyads, who will receive standard maternal
and child health care programs, will be identified in the control clusters. Data will be collected on anthropometry, feeding practices and hygiene and caring practices etc. We will report the results for 2-sided 5% tests for the primary trial outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age, feeding patterns, and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. We will use linear mixed models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage exclusively breastfeeding). It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.
KEY PERSONNEL (List names of all investigators including PI and their respective specialties)
Name 1. 2. 3. 4. 5. 6. 7. 8. 9.
Dr. A. K. M. Iqbal Kabir Dr. Michael J Dibley Dr. S. K. Roy Seema Mihrshahi Dr. Kingsley E. Agho Dr. Anadil Alam
Professional Discipline/ Specialty Clinical and Public health nutrition scientist Nutritional epidemiologist Clinical and Nutrition Research Public Health research Public Health and Demoghraphy Clinical & Public Health Nutrition
Role in the Project Principal Investigator Principal Investigator Co-Principal Investigator Co-Investigator Co-Investigator Associate Investigator
10.
Description of the Research Project

Hypothesis to be Tested:
Please briefly list the Hypothesis to be tested and provide the scientific basis of the hypothesis, critically examining the observations leading to the formulation of the hypothesis.
We hypothesised that in a community-based, cluster randomized controlled trial (CRCT) of women from a socio-economically disadvantaged community in Bangladesh, a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery will reduce the prevalence of stunting (height-for-age < -2 Z) in their children at 18 months of age by 10% (35% in control to 25% in intervention group) compared with women with no peer counselling. Specific Aims:
Describe the specific aims of the proposed study. State the specific parameters, biological functions, rates, processes etc. that will be assessed by specific methods.
Main objective:
The main aim of the study is to use a cluster RCT to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children. Specifically, the aims of the trial are to evaluate if a peer counselling, behavioural change education program for women: 1) Improves breastfeeding and complementary feeding of their children, and 2) Improves the growth and reduces the prevalence of stunting of their children at 18 months. Secondary objectives 1) The percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 3 and 6 months will be increased, in the peer counselling group, compared with mothers without the intervention. 2) The mean duration of any breastfeeding will be increased, in the peer counselling group, compared with mothers without the intervention. 3) The percentage of women bottle feeding (any liquid or semi-solid food from a bottle with nipple/teat) their infants at 12 months will be decreased, in the peer counselling group, compared with mothers without the intervention.
4) The percentage of children at 6 and 9 months of age who receive solid, semi-solid or soft foods will be increased, in the peer counselling group, compared with mothers without the intervention. 5) The percentage of children consuming foods from >4 food groups at 9, 12, 15 and 18 months will be increased, in peer counselling group, compared with mothers without the intervention. 6) Mean intake of food energy, protein, carbohydrate, fat and selected micronutrients (e.g. zinc, iron, vitamin A) from complementary feeds at 9, 12, 15 and 18 months will be increased, in the children in the peer counselling group, compared with mothers without the intervention.
Background of the Project including Preliminary Observations

Provide relevant background of the proposed study, and discuss the previous works on the research topic by citing specific references. Describe in a logical way how the present hypothesis is supported by the relevant background observations including any preliminary results that may be available. Provide scientific validity of the hypothesis on the basis of background information Critically analyze available knowledge in the field of the proposed study and discuss the questions and gaps in the knowledge that need to be fulfilled to achieve the proposed goals.. If there is no sufficient information on the subject, indicate the need to develop new knowledge. Also include the significance and rationale of the proposed work by specifically discussing how these accomplishments will bring benefit to human health in relation to biomedical, social, and environmental perspectives.
Infant feeding and child malnutrition Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia,[1] with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries.[4] The risk of child death is also related to the severity of malnutrition and progressively increases the more the childs growth deviates from WHO Growth Standard, e.g. children with height-for-age <-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean.[1] Underweight in children for 18.7% of the global disability-adjusted life years in children less than five years of age.[5] Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations.[6] Suboptimal feeding is also an important contributor to child mortality accounting for 10% of the global DALYs for children younger than 5 years of age.[5] It is recommended that children be exclusively breastfeed until 6 months of age, although in Bangladesh in 2004 the prevalence of this feeding practise was only 36%[6] Infants less than 6 months who are not breastfed have a 14 fold increased mortality risk compared to exclusively breastfed infants.[1] Even infants less than 6
months who are just given water-based liquids in addition to breastmilk have a 48% increased mortality risk compared to exclusively breastfed infants.[1] Inappropriate breastfeeding increases the risks of childhood morbidity, which in turn potentially contributes to the development of stunting and wasting. Although strategies for promoting appropriate breastfeeding have a large effect on survival, their effect on stunting appears to be much smaller.[5] Most postnatal growth faltering occurs during the first 2 years of life, and studies have shown that even with optimum breastfeeding, growth faltering will occur if children do not receive an adequate quantity and quality of complementary foods after 6 months of age.[2] This occurs because at this age children have a higher demand for nutrients and also a higher rate of infectious diseases such as diarrhoea, which adversely affects growth and nutritional status. A lack of diversity of foods given to young children also contributes to malnutrition. For example animal-source foods are an important source of protein micronutrients, such as zinc, and low intakes of these foods are related to stunting in children.[1] Improved breastfeeding practices and more diverse foods and increased frequency of complementary feeds can help protect infants from childhood malnutrition.
Peer counselling and infant feeding An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. A recent study has conducted on pioneering research on this approach in Bangladesh.[3] A recent meta-analysis of individual peer counselling for the promotion of exclusive breastfeeding found that the odds of exclusive breastfeeding in mothers receiving the counselling was substantially increased in the neonatal period (15 studies; odds ratio [OR] 345, 95% CI 220542, p<00001; random effects) and at 6 months of age (nine studies; 193, 118315, p<00001).[5] Similar results were also reported for group peer counselling. Education about complementary feeding has been reported in a meta-analysis to increase height-forage Z score by 025 (95% CI 001049).[5] In the studies included in this meta-analysis the education messages were delivered by health care providers at routine contacts with health system. To date there have been no reports of using a peer support approach to educate, support and skill mothers about appropriate complementary feeding. In unpublished work, CI-B has conducted a pilot study to examine the impact of this approach in a lower socio-economic population in urban Dhaka, Bangladesh. Peer counsellors were identified from a community in which they had been delivering peer support for exclusive breastfeeding and starting complementary feeding at around six months of life. These peer counsellors were given
additional training on complementary feeding and in particular on how to promote two types of complementary foods, 1) Rice gruel + soybean oil, and 2) Rice + lentil+ soybean oil (Khichuri. These complementary food recipes were selected based on formative research that examined the types of foods being given to young children in urban Dhaka and were modified to increase their energy content. Two hundred and seventy-nine mothers in the intervention area and 277 mothers in the control area (without peer counsellors) were followed up until their infants were 12-month age. The rate of exclusive breast feeding was 69% in the intervention area compared with only 6% in the control area at six months. In the intervention group 73% of mothers gave rice gruel to their children at six months compared to 60% mothers in the control area (p<0.005). Khichuri was given by 18% mothers in the intervention area compared with 9% mothers in the control area (p<0.003). The proportions of the mothers who continue to give khichuri remained significantly higher in the intervention group compared with control at 12 months (26.8% vs. 13%, p<0.001). However, there were no significant differences in the proportions of mothers giving rice gruel diet during this period. Significantly more mothers used bottle to give complementary feeds in the control area compared with intervention area (43% Vs 14.5% for control and intervention groups respectively; p< 001). Similarly, the proportions of mothers who gave complementary feeds by spoon was significantly higher in intervention area compared with control (88% vs. 54%, p<0.001). These results suggest that, peer counsellors can improve infant feeding practices by increasing exclusive breastfeeding and appropriate complementary feeds. The results demonstrate the feasibility of implementing the intervention in an urban population in Bangladesh with evidence of changed feeding behaviours. The impact of this intervention on child malnutrition needs to be examined. Outcomes and Significance Importance of the problem: Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 35% of child deaths and 11% of the total global disease burden.[1] Developing effective and sustainable interventions to improve infant feeding will be integral components of efforts to reach the child survival and malnutrition Millennium Development Goals. Planned outcome of the research plan: The proposed research will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. Potential significance of the research: To date there have been no interventions that include peercounselling to improve infant feeding practices over the first 18 months of life. The potential intensity and duration of the intervention is likely to result in a reduced rate of malnutrition and will be of great interest to public health planners in developing countries. It is expected that the
publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.
Research Design and Methods

Describe in detail the methods and procedures to be used in accomplishing the objectives and specific aims of the project. Discuss the alternative methods that are available and justify the use of the method proposed in the study. Justify the scientific validity of the methodological approach (biomedical, social, or environmental) as an investigation tool to achieve the specific aims. Discuss the limitations and difficulties of the proposed procedures and sufficiently justify the use of them. Discuss the ethical issues related to biomedical and social research for employing special procedures, such as invasive procedures in sick children, use of isotopes or any other hazardous materials, or social questionnaires relating to individual privacy. Point out safety procedures to be observed for protection of individuals during any situations or materials that may be injurious to human health. The methodology section should be sufficiently descriptive to allow the reviewers to make valid and unambiguous assessment of the project.
1. Experimental design a. Study design We will use a community-based CRCT to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery, to improve child feeding practices, child growth and reduce the prevalence of malnutrition in their children. This will result in two study groups (see diagram). The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because we expect a likely high correlation between baseline and follow up outcome measures, thus making this approach the most efficient study design.[7]
The trial will be conducted in a total of 50 community clusters (Mallahas smallest geographic units in Dhaka see details below in Sampling Scheme), with 25 clusters in each study group. The peer counseling education intervention will be delivered to the mothers, by locally recruited and trained peer counsellors, starting in the third trimester of pregnancy until the child is one year of age. The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. Using a similar approach to recruitment, a cohort of mother-infant dyads, who will receive standard maternal and child health care programs, will be identified in the control clusters.
Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 1950 mother-infant dyads (975 in each treatment group). There will be a baseline assessment and further assessments every 3 months from birth until the children are 18 months of age. Two of these assessments (when infant is 15 and 18 months of age) will be made after the education intervention has ceased to assess the sustained impacts on the prevalence of child stunting and infant feeding practices (see evaluation plan for details).
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In this CRCT the interventions will be allocated at a community level, but the outcome assessments will be at the individual level. This is the best comparative design for the proposed interventions, which cannot be delivered to individual mothers in densely populated urban slum communities to avoid contamination of the intervention. A four year study is required to ensure an adequate dose of the intervention is delivered to the mothers in the intervention group, and to give time to evaluate the longer-term impact of the interventions. RANDOMIZATION PROCEDURE:
I e tf d ni y i Mp r n i u r
5 ei i l a al s 0 l gbe Mh l a , Da a hk , Bn ad s a gl e h
Rn o i ai n a d m to z b a al s y Mh l a
P e c u s l i gi f n e r o n el n na t f e i ge u ai n e dn d c to pu l s Uu l M H r ga s s a C po r m
Uu l M H r ga s s a C po r m
Rcut e to e r i mn f pe n n mt es r g a t oh r
Rcut e to e r i mn f pe n n mt es r g a t oh r
Cn e t osn
Cn e t osn
Bs l n a ei e a s s mn ses e t
Bs l n a ei e a s s mn ses e t
Cu s li g o n el n
Uu l M H sa C
Uu l M H sa C
S ot hr Lne ogr
E u ai n d c to
Po r m r ga s
A ses e t s s mns
A ses e t s s mns
o i f nsa f na t t 3, 6, 9 & 1 mnh 2 ot s

S ot hr -t r I p c emma t As e s e t s s mns
o i f nsa f na t t 3, 6, 9 & 1 mnh 2 ot s

-t r I p c emma t As e s e t s s mns
o i f nsa f na t t 1 & 1 mnh 2 8 ot s

Lne ogr -t r I p c emma t
o i f nsa f na t t 1 & 1 mnh 2 8 ot s

-t r I p c emma t
Po r m r ga s
Pe er
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b. Sampling scheme The proposed field area for the study is Mirpur, an auxiliary Thana in the Dhaka Metropolitan City Corporation with a total population of 5,580,000 (according to the Census 2001, although it may have increased by a further 20% to 30% since then). Mirpur has 16 Wards which are the smallest urban administrative unit each of which has a local government authority called a Ward Council. The average population of a Ward is 350,000 people. Below the Wards are "Mahallas" which are the lowest urban geographic unit with identifiable boundaries. On average there are five Mahallas per Ward with an average population of 70,000 people. The unit of randomization for the trial will be Mahallas. In Mirpur there will be a total of 80 Mahallas, which will form the sampling frame for selecting the clusters in the trial. The list of these Mahallas is available from the Dhaka Metropolitan City Corporation. The definition of the crude birth rate (CBR) is the number of births per 1,000 population during a specified time period.[6] The 2004 Bangladesh DHS reported a current CBR for urban Bangladesh of 25.8 per 1000 population for 3 years prior to survey. Thus the average expected number of births for each Mahallas over a 3 month period would be 150, which would be more than the required recruitment number for the trial and ensuring the feasibility of the sampling scheme for the trial. c. Recruitment and inclusion/exclusion criteria for clusters
Source: http: //banglapedia.search.com.bd/HT/M_0260.htm
Mallahas on the sampling frame will be eligible for the study if they do not have any other infant feeding interventions currently being implemented either from the government of non-government sectors. Any such programs will be identified by contacting local officials in the Ward Councils in Mirpur. At present there are no infant feeding promotion programs run by the government health services in this area. The Dhaka Metropolitan City Corporation will be contacted in person to obtain their written approval for the study before the Mahallas are allocated to a treatment group or trial recruitment of subjects begins. d. Assignment of treatments The interventions will be assigned to eligible Mallahas using a fixed randomisation scheme with uniform allocation ratio of treatments, and blocks of 5 or 10 to ensure geographic balance across Mirpur area. The random allocation sequence will be generated using SAS software.
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e. Recruitment, inclusion/exclusion criteria and consent of mothers and their families A previously successful approach to recruitment[3] will be used in which trained field assistants will identify women who are in their third trimester of pregnancy by systematic door-to-door surveys across the Mahallas over a 3 month period. Pregnant women will be included who are 16 to 35 years with no more than three living children. Women who plan to migrate from the Mirpur area after delivery will be excluded. Also women with documented medical records of heart disease, tuberculosis, gestational diabetes or eclampsia in previous pregnancies will be excluded. Mother-infants pairs will also be excluded where there are multiple births, congenital abnormalities, very low birthweight below 1.5 kg or infant admitted to a neonatal intensive care unit. Based on experience with similar projects in Bangladesh[3,8] it is expected that at least 95% of the mothers will consent to participate. It is also likely that up to 30% will be excluded mainly related to their desire to migrate back to their home village after the delivery.[3]
Sample Size Calculation and Outcome (Primary and Secondary) Variable(s) The sample size for the trial was estimated with the following assumptions:
Sample size calculation for increasing the rates of exclusive breastfeeding in the intervention group Considering the rate of EBF 43% in the control clusters (BDHS 2007) and the expected rate of EBF about 63% i.e. an increase of 20% in the intervention group the required sample size will be 92.4 for each group and using formula; n= P1(100-p1) + P2 (100-p2)/(P2-P1)2 x 7.9 Taking 95 (round up the figure) and multiplying by 4 to reduce the cluster effect the sample size become 380. Calculating a 20% drop out, out migration the required sample size comes to 456 in each group to have a 0.05 significance and with a power of 0.80.
Each community-cluster (Mahalla) has an average population of 70,000 and an expected
crude birth rate of 4.3 per 1000 total population over 6 months [based on CBR for urban Bangladesh of 25.8/1000 population over 36 months from 2004 Bangladesh DHS[6]] thus giving an average expected number of births of 150 over a 3 month period per Mahalla cluster.
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Previous research[3] indicates that appropriately 33% of pregnant women will return to
their home village following the delivery, thus leaving an expected number of eligible births of 200 over a 6 month period per Mahalla cluster. 39 mother-infant dyads per Mahalla cluster assuming 95% participation but 22% loss to follow-up based on earlier research,[3] from the approximately 200 mother-infant dyads available in each cluster over a 6 month period. 90% power and 5% two-sided alpha Intra-cluster correlation coefficient (ICC) of 0.015 [based on analyses of the child
anthropometric measurements from the 2004 Bangladesh DHS survey data for urban child populations.[6].] Expected difference in the prevalence of stunting between the treatment groups of 10% (35% in control to 25% in intervention group), which is similar to the change reported in an earlier education intervention for young child feeding in Peru.[10]
The sample size required would be 1950 mother-infant pairs (975 in each treatment group) from 50 Mallahas clusters with 39 mother-infant dyads per community cluster recruited over 3 months[7,11] Facilities Available
Describe the availability of physical facilities at site of conduction of the study. For clinical and laboratory-based studies, indicate the provision of hospital and other types of adequate patient care and laboratory support services. Identify the laboratory facilities and major equipment that will be required for the study. For field studies, describe the field area including its size, population, and means of communications.
(a). (b). (c).
Manpower Administrative infra-structure Expertise
(d).
Anthropometric equipment's
Intervention plan The trial intervention has been selected because its feasibility has been tested in urban populations in Dhaka, and it is likely to be sustainable in the future. The proposed individual peer counseling education will be of sufficient intensity to alter infant and young child feeding practices and to improve the growth of the young children and prevent malnutrition. After one year of preparations for the trial, the interventions will be delivered to the women starting in pregnancy and until their child is one year of age over the second and third years of the study. a. Description of intervention
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The approach to promoting appropriate infant and young child feeding will be through a program of home-based peer counselling by trained, local women from the mothers community. This approach will reach mothers who deliver at home and will also allow the messages to reach other key family members who may play a role in supporting breastfeeding and influence the foods choices for the infant. The main messages will be directed at encouraging early initiation of breastfeeding, promoting exclusive breastfeeding during the first 6 months of life, promoting appropriate timing of the introduction of complementary feeds, and ensuring an adequate frequency of feeds and diversity of foods used in their preparation. i) Selection and training of peer counsellors Women with personal breastfeeding experience, at least 6 years of schooling, residing in the same area, and motivated to work will be selected to become peer counselors. The WHO/UNICEF Breastfeeding Counseling Course adopted to the local language and culture, which has already been validated in a previous study[3] will be used for training of peer counselors. The training will be given for 40-h (4-h daily for 10 days). Counseling skills will be taught mainly by demonstrations and role play and will include: listening to mothers, learning about their difficulties, assessing the position and attachment of babies during breastfeeding, building mothers confidence, giving support and providing relevant information and practical help when required. During the training course antenatal and postpartum counseling will be practiced with pregnant women, mothers with newborns and infants aged 1-12 months in the field site. The counselors will also be taught how to use locally available foods for complementary feeding of infants and young children, and how best to demonstrate these food preparation skills to mothers. It is anticipated that each peer counselor will be able to support up to approximately 10 mothers and thus to provide support to the approximately 1000 women receiving the intervention (see section 4.a. Sample Size and Power for details) 100 peer counselors (four in each community cluster) will need to be recruited and trained. The performance of the counselors will be monitored at least four times during the course of the study by the Senior Infant Feeding Counselors. ii) Counselling schedules: There will be a schedule of at least 13 visits by the peer counsellors: two before delivery; four during the first month; five monthly visits from age 2 to 6 months; and three monthly visits at age 9 and 12 months. The counsellors will be free to make additional visits if the mothers circumstances require them. The counselling will take place at home to ensure key family members (e.g. mother-in-law and fathers) can also be included in the counselling sessions. The duration of each visit will be from 20 to 40 minutes.
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Antenatal visits: The peer counsellors during the two antenatal contacts will prepare the mothers, and other members of the family who will support her at delivery, about the importance of holding the baby within a few minutes of delivery and how to initiate breastfeeding within one hour of delivery. They will discourage prelacteal feeds and other fluids and foods after lactation has been initiated. They will encourage the mothers to eat more of their usual foods to support enhanced lactation, and to appropriately rest during the third trimester. These meetings will also cover problems with breastfeeding that the mother might encounter and how best to deal with them.
Visits in the first month of life: The mothers will be contacted four times by the peer counsellors (within 48 hours of delivery, at 5-7 days, at 10-14 days and at 24-28 days). At these visits exclusive breastfeeding will be encouraged and the mothers specific needs addressed. Issues that could be covered include sore nipples, problems with attachment tot eh breast, the babys position during feeds, family pressure to start other foods and mothers doubts about the adequacy of their Breastmilk. If any of these issues could not be resolved the mothers could be referred to the Senior Infant Feeding Counsellors. Visits 2 to 6 months of life: The mothers will be contacted monthly by the peer counsellors. Specific problems will be addressed and continued support for exclusive breastfeeding will be provided especially how to deal with family pressures to introduce other foods and concerns about the adequacy of the growth of the infant. From 5 months of age specific messages that include, the importance of complementary feeding, demonstration and preparation of complementary foods will be introduced. Mothers will be given measuring cups and spoons and two types of complementary foods will be demonstrated. The two types of complementary feeds to be promoted are based on prior survey of foods given to young children in urban Dhaka. The first will be ricesuzi (powdered rice + soybean oil to make it energy dense), and the second will be Khichri (cooked rice + lentil + soybean oil). Mothers will also be discouraged from using bottles for feeding.
Visits from 6 to 12 months of life: The mothers will be contacted twice at 3 month intervals by the peer counsellors. The mothers will be encouraged to continue breastfeeding and support will be given for an adequate frequency of complementary feeds and an appropriate diversity foods. There will be further demonstrations of the preparation of complementary feeds as needed.
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b. Management of interventions There will be two senior infant feeding counsellors who will train the peer counsellors under supervisor of CI-B. These senior counsellors will provide technical support to the peer counsellors and help them resolve problems they encounter during the implementation of the trial interventions by regular meetings with peer counsellors in the field. . There will be 10 field supervisors who will support the day-to-day logistics and administration of the field activities including support for the senior infant feeding counsellors when they are in the field and the per counsellors. To facilitate the overall implementation process, an advisory committee consisting of a local health officers, local government officials, representatives of mothers groups from the community, representatives of the Bangladesh Breastfeeding Foundation, other relevant NGOs and project staff will help guide the research team and will meet every 3 months as the project progresses. 3. Evaluation plan a. Outcome assessment i) Key trial outcomes Differences in the percentage of stunted infants (height-for-age <-2 Z) at 6, 12 and 18
months. Changes in mean height-for age Z scores from birth till 18 months Changes in the percentage of women exclusively breastfeeding (breast milk and no other
foods or milk based liquids) their infants at 3 and 6 months. Changes in mean duration of any breastfeeding. Changes in the percentage of women bottle feeding (any liquid or semi-solid food from a
bottle with nipple/teat) their infants at 9 and 12 months. Changes in percentage of children at 6 & 9 months who receive solid, semi-solid or soft
foods. Changes in percentage of children consuming foods from >4 food groups at 9, 12, 15 & 18
months. Changes in the mean intake of food energy, protein, carbohydrate, fat and selected
micronutrients from complementary feeds at 9, 12, 15 and 18 months. ii) Measurements 1. Anthropometry:
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Trained research assistants will collect anthropometric measurements (weight and height) using established methods[9] and will record these measurements on both the research instruments and an infant growth chart for the mother to hold.. These measurements will be standardised before and during the data collection. Anthropometry will be collected soon after birth and at 3 month intervals (3, 6, 9, 12, 15 and 18 months). The 2006 WHO Growth Standard will be used to construct anthropometric indices and standard WHO recommended indicators will be used to assess stunting (Height-for-age <-2 Z), wasting (weight-for-height <-2 Z) and underweight (weight-for-age <-2 Z).
2. Infant feeding practices: Standard questions about infant feeding practices used in the Bangladesh DHS surveys[6] will be used to monitor these patterns at the 3 monthly data collection periods from birth till 18 months of age. These will include questions about current breastfeeding status, current use of other liquids and solid foods, timing of introduction of other liquids or solid foods, use of bottles for feeding and information about who is providing advice about infant feeding amongst family and friends. Ten percent of the interviewers scheduled visits will be monitored by one of the Senior Research Assistants or Principal Investigators or Investigators. The questionnaires will be checked daily, and if the information is incomplete or not clear, the supervisor will return to the home on the next day to complete the data form. Mothers reported infant feeding practice will be verified by a 4-hour observation period that will take place by unscheduled visits by Senior Research Assistants or Principal Investigators or Investigators. 3. Infant and maternal morbidity Infant Morbidity Illness histories such as diarrhoea, dysentery (blood and/or mucus), fever and cough, ear infection (purulent discharge) from ears will be obtained at 3, 6 and 12 and 18 months using 2-weeks recall method. ear discharge. Diarrhoea will be defined as an episode of the passage of three or more loose or watery stools within 24 hours. Presence of blood with stool will be defined as invasive
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The questions asked will be based on the
standard DHS infant morbidity recall questions but expanded to include questions about
diarrhea. When a single episode of diarrhea lasts for more than two weeks, it will be called persistent diarrhoea. Acute respiratory illnesses will be define as an episode of cough with reported fast and rapid breathing or difficulty breathing with or without fever. Maternal morbidity A simple recall method will be used to assess morbidity in the mothers. They will be asked to recall, over the month preceding the interview, any days they were ill enough to have their usual daily activities restricted. If they have experienced restricted day illness they will be asked about key symptoms (cough, diarrhoea, urinary discomfort and fever). A medical history will be collected at baseline to capture information about maternal chronic illnesses as well. The total number of restricted days and the number of restricted days with fever will be used in analyses of their relationship with feeding practises. If maternal morbidity is equally distributed across the treatment groups we would not expect that this factor would bias the trial results. 4. Dietary intake: Trained interviewers will collect 24-hr dietary recalls using standard methods starting at 6 months of age till 18 months. All the foods consumed in the 24 hours prior to interview will be recorded and portion sizes measured in local utensils. Recipes used to prepare foods will be recorded including the amounts of raw food used and the preparation methods. The foods will be coded by the research assistants and nutrient calculated in special purpose programs using the Bangladesh Food Composition Tables. Both nutrient intakes and food groups consumed will be analyzed and presented. Duplicate 24 hour recalls will be taken in a 10% subsample of respondents to assess within person variability and to allow adjustment of the prevalence of low intake nutrients. 5. Focus group discussion: A Focus Group Discussion (FGD) is an unique method of qualitative research that tries to find the views of people in a group through an interactive way. FGD will be conducted with the mothers to learn about their perception and practices on child feeding and dietary pattern. FGD will be focus on (1) Perception on Colostrum, TIBF, EBF, continuation of BF, and complementary feeding.
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(2) Constraints to feeding colostrum, EBF, continuation of BF, and complementary feeding. (3) Perception, causes, possible consequences of malnutrition from mothers that they experience in their day to day life. (4) The perceptions on food security of children like complementary feeding practice and pattern and adequacy of breast feeding. (5) Perception on disease, services taken during illness. (6) Beliefs about appropriate types of complementary feeding The FGDs will be conducted with mothers in 6 groups from the intervention areas and 6 groups from the control areas from randomly selected communities. Each FGD will consist of 6 to 8 participants, and will be held at a location and time, which is convenient for the group. The FGD will be conducted over 2 hours for each group. A trained Field Research Officer will facilitate the session. The group facilitator will be assisted by research personnel, who will record all answers in several broad categories. She will also record the session using cassette player for later transcription and translation. and terms. A statistical program ATLAS ti will be used for qualitative data analysis which will use 1) Free listing. 2) File sorting and 3) Rating. Dr. Sabrina Rashid an anthropologist has been included in the study team (as consultant) who has expertise in qualitative data analysis. iii) Schedule of data collection 1. A pilot study will be conducted in the first year of the study in a single cluster to test the recruitment methods, the implementation of the intervention and the evaluation instruments and field methods before commencing the trial. 2. Assessment of trial outcomes: A baseline survey at enrollment will be used to collect basic socio-demographic information about the family and the maternal characteristics. The details of the birth and pregnancy will be recorded shortly after delivery. The trial outcomes will be assessed by a series of measurements taken at 3 monthly intervals from birth until 18 months of age. These include anthropometry, recording of dietary patterns and dietary intake. The qualitative answers will then be transformed into quantitative expression. The data from the focus groups will be analyzed to extract essential issues
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b. Process assessment is needed to examine the fidelity, dose, reach and intensity of interventions: i) Participation of mothers in peer counselling sessions ii) Self report adherence to peer counselling guidelines by the peer counsellors iii) Unscheduled observations of the peer counsellors at home visits iv) Focus groups & open ended questions with mothers & peer counsellors about the program This data will be collected during the implementation of the interventions, and by focus groups at the end of the intervention year. Data Safety Monitoring Plan (DSMP)
All clinical investigations (biomedical and behavioural intervention research protocols) should include the Data and Safety Monitoring Plan (DSMP) to provide the overall framework for the research protocols data and safety monitoring. It is not necessary that the DSMP covers all possible aspects of each element. When designing an appropriate DSMP, the following should be kept in mind. a) b) c) d) All investigations require monitoring; The benefits of the investigation should outweigh the risks; The monitoring plan should commensurate with risk; and Monitoring should be with the size and complexity of the investigation.
Safety monitoring is defined as any process during clinical trails that involves the review of accumulated outcome data for groups of patients to determine if any treatment procedure practiced should be altered or not.
Data will be kept confidential and following their collection will be accessible to only the investigators and Ethical Review Committee of ICDDR, B. The field staff will be advised to maintain all information/ data confidential, which may be shared with respondent or the guardian if requested. Data will be coded at the level of computer entry. All data will remain the property of ICDDR, B. The contractor will not have right to retain a copy of data set in case the part of the study is contracted out. Quality Control of the study: A major responsibility of ICDDR,B would be to ensure quality and authenticity of data generated from the study, and their analyses. The Independent Quality Control Team (IQCT), comprising of representatives of ICDDR,B, will visit the survey sites and re-interview and re-examine a randomly selected 2% of the respondents interviewed over the preceding 15 days. The team will observe onsite interviews and anthropometric measurements of the under-2. Discrepancies noted during external validation will be resolved in discussion with the survey agency. A quality control team will retain the survey team, if necessary. If gross errors are found, respective staff will be removed.
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Data Safety: Data will be kept confidential and will not be available to anybody except the investigators. Data collecting personnel will be advised and motivated to keep the information confidential, and data may be shared only with respective respondent or participating parents/ primary caregivers if requested. Data will not carry the name of the participants and instead codes will be entered onto computer.
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Time line for survey study

Months of studies
Works to be ac co m pl is he d 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Approval Screening for target population/Study set-up/Mapping Recruitment & Training Pilot study Enrolment, Intervention & Monitoring Follow up Data Collection Data Entry
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Data analysis Report writing
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Data Analysis
Describe plans for data analysis. Indicate whether data will be analysed by the investigators themselves or by other professionals. Specify what statistical software packages will be used and if the study is blinded, when the code will be opened. For clinical trials, indicate if interim data analysis will be required to determine further course of the study.
Quantitative Data analysis plan: Data analysis will be by intention to treat. Analyses will be conducted at the mother-infant dyad level, but will be adjusted for the community-cluster randomization.[12] The primary analyses will compare the prevalence of stunting (height-for-age < -2 Z) in children at 24 months of age using Pearsons chi-square tests and 95% confidence intervals for the group difference, adjusted for clustering. We will report the results for 2-sided 5% tests for the primary trial outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age, feeding patterns, and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. We will use linear mixed models for continuous outcomes (e.g. height-forage Z) and generalized linear mixed models for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage exclusively breastfeeding). Models will include treatment group as a fixed effect, infants as a random effect to account for the repeated measurements, and community-cluster as a random effect to account for the cluster effect. The models will be able to evaluate the impact of the interventions over time by testing for an interaction between time and intervention group. Analyses will be conducted to identify the baseline characteristics of mother-infant dyads who may benefit most from the intervention. Model assumptions will be checked and appropriate adjustments to the analysis will be made where necessary. STATA software version 10.1 (2008; Stata Corporation, College Station, TX, USA) will be used for all analyses, with xtmixed command to fit linear mixed models and xtmelogit command to fit mixed-effects models for binary outcomes/responses.
Analysis of qualitative data: Data collected from the focus group discussion and observation will be ordered, reduced and coded according to the qualitative data analysis method (Applied Health Research Manual: Anthropology of Health & Medical Care). All qualitative data will be summarized and a detailed report will be presented. Emphasis will be given on changes in KAP (Knowledge, Attitude and Practice), BCC (Behaviour Change Communication) among the parents/ primary caregivers of participating children. Statements about various important issues. Matrix, diagram and flow chart will be presented as the reason /origin (both socio-economical) behind peer counselling, exclusive
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breastfeeding, continuation of breastfeeding, complementary feeding, malnutrition, failure to improve nutritional status by the study subjects. Ethical Assurance for Protection of Human Rights
Describe the justifications for conducting this research in human participants. If the study needs observations on sick individuals, provide sufficient reasons for using them. Indicate how participants rights will be protected, and if there would be benefit or risk to each participants of the study.
Written informed consent will be obtained from patients/ primary caregivers of respective children after explaining to them the purpose of the study, and its methods, risks and benefits, and confidential handling of personal information, as well as the voluntary nature of participation and the rights to withdraw from the study without any penalty or prejudice.
Use of Animals
Describe if and the type and species of animals to be used in the study. Justify with reasons the use of particular animal species in the experiment and the compliance of the animal ethical guidelines for conducting the proposed procedures.
This study doesnt involve use of any animal.
Literature Cited
Identify all cited references to published literature in the text by number in parentheses. List all cited references sequentially as they appear in the text. For unpublished references, provide complete information in the text and do not include them in the list of Literature Cited. There is no page limit for this section, however, exercise judgment in assessing the standard length.
References 1. Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, et al. (2008) Maternal and child undernutrition: global and regional exposures and health consequences.[see comment]. Lancet 371: 243-260. 2. Dewey KG, Brown KH (2003) Update on technical issues concerning complementary feeding of young children in developing countries and implications for intervention programs.[erratum appears in Food Nutr Bull. 2003 Jun;24(2):239]. Food & Nutrition Bulletin 24: 5-28. 3. Haider R, Ashworth A, Kabir I, Huttly S (2000) Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial [see commments]. Lancet 356: 1643 - 1647. 4. Caulfield LE, de Onis M, Blossner M, Black RE (2004) Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr 80: 193-198.
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5. Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, et al. (2008) What works? Interventions for maternal and child undernutrition and survival.[see comment]. Lancet 371: 417-440. 6. National Institute of Population Research and Training (NIPORT), Mitra and Associates, Macro. O (2005) Bangladesh Demographic and Health Survey 2004. Dhaka, Bangladesh and Calverton, Maryland [USA]: National Institute of Population Research and Training, Mitra and Associates, and ORC Macro. 7. Murray DM (1998) Design and Analysis of Group-Randomized Trials. New York: Oxford University Press 190-211 p. 8. Arifeen S, Black R, Antelman G, Baqui A, Caulfield L, et al. (2001) Exclusive breastfeeding reduces acute respiratory infection and diarrhea deaths among infants in Dhaka slums. Pediatrics 108: E67. 9. Lohman TG, Roche AF, Martorell R (1991) Anthropometric Standardization Reference Manual. Champaign: A Division of Human Kinetics Publishers. 10. Penny ME, Creed-Kanashiro HM, Robert RC, Narro MR, Caulfield LE, et al. (2005) Effectiveness of an educational intervention delivered through the health services to improve nutrition in young children: a cluster-randomised controlled trial. Lancet 365: 1863-1872. 11. Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM (2004) Sample size calculator for cluster randomized trials. Comput Biol Med 34: 113-125. 12. Donner A, Klar N (2000) Design and analysis of cluster randomization trials in health research. London: Arnold. x,178 p. p. Dissemination and Use of Findings
Describe explicitly the plans for disseminating the accomplished results. Describe if and how the research findings would be shared with stakeholder, identifying them if known, and the mechanism to be used. Also describe what type of publication is anticipated: working papers, internal (institutional) publication, international publications, international conferences and agencies, workshops etc. Indicate, if the project is linked to the Government of the Peoples Republic of Bangladesh through a training programme or a collaborative arrangement.
The results of this study will be shared with the government of Bangladesh, and will be disseminated at ICDDR.,Bs and national and international seminars. Results will also be published in international peer-reviewed journal(s) for sharing with larger scientific community.
Collaborative Arrangements
Briefly describe if this study involves any scientific, administrative, fiscal, or programmatic arrangements with other national or international organizations or individuals. Indicate the nature and extent of collaboration and include a letter of agreement between the applicant or his/her organization and the collaborating organization.
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This trial will conduct by the investigators collaboratively. One of the Principal investigators is from the University of Sydney and there are also two more Investigators from The University of Western Sydney and the Queensland University of Technology Biography of the Investigators
Give biographical data in the following table for key personnel including the Principal Investigator. Use a photocopy of this page for each investigator. (Note: Biography of the external Investigators may, however, be submitted in the format as convenient to them)
Biography of the Investigators

Name: A.K.M. Iqbal Kabir
2 Present Position: Scientist & Coordinator, Clinical Unit C, Clinical Sciences Division, Head (Previuosly), Breastfeeding Counselling Service and Research Unit, ICDDR,B 3 Educational background: MBBS /1975 Dhaka Medical College; M.D./1986, Case Western Reserve University, Cleveland, USA Gastroenterology & Clin Nutr Ph.D./1992, Dhaka University in nutrition
(last degree and diploma & training
relevant to the present research proposal)
4.0 List of ongoing research protocols

(start and end dates; and percentage of time)
4.1.
As Principal Investigator
Protocol Number 2008053 01211733 (BC) Starting date 01-08-08 15-09-07 End date 01-08-10 29-06-10 Percentage of time 30% 20%
4.2.
As Co-Principal Investigator
Protocol Number Starting date End date Percentage of time
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4.3.
As Co-Investigator
5 Publications a. Types of publications Original scientific papers in peer-review journals Peer reviewed articles and book chapters Papers in conference proceedings Letters, editorials, annotations, and abstracts in peer-reviewed journals Working papers Monographs Numbers 91 4 30 70
b.
c. d. e. f.
Five recent publications including publications relevant to the present research protocol
1) Enneroth H, El Arifeen S, Persson LA, Kabir I, Lonnerdal B, Hussain MB, Ekstrom EC. Duration of exclusive breastfeeding and infant iron and zinc status in rural Bangladesh. J Nutr 2009, 139: 1562-1567. 2) Mihrshahi S, Oddy WH, Peat JK, Kabir I: Association between breastfeeding pattern and diarrhoeal and respiratory illness: a cohort study in Chittagong, Bangladesh. Int Breastfeeding J 2008; Nov 24 (3): 283) Fangstrom B, Moore S, Barbo N, Kunstl L, Goessler W, Grander M, Kabir I, Palm B, Arifeeen SE, Vahter M. Breast-feeding protects against arsenic exposure in Bangladeshi infants. Environ Health Perspect 2008; 116: 963-69.
Bhandari N, Kabir AKMI, Salam MA. Mainstreaming nutrition in maternal and child health program; scaling up of exclusive breastfeeding. Matern Child Nutr 2008; Apr 4(supple 1): 5-23.
4) 5) Moore SE, Prentice AM, Coward WA, Wright A, Frongillo EA, Fulford AJC, Mander
AP, Persson LA, Arifeen SE, Kabir I. Use of stable-isotope techniques to validate infant feeding practices reported by Bangladeshi women receiving breastfeeding counseling. Am J Clin Nutr 2007;85:1075-82.
1. Name: Michael J. Dibley

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2 Present Position: Associate Professor in International Public Health School of Public Health, The University of Sydney, NSW Australia
Educational background:
Master of Public Health, 1988, Emory University ,School of Public Health, Atlanta, GA, U.S.A, Epidemiology Postgraduate Training in Nutrition in Health and Disease, 1982, Dunn Nutrition Unit, Cambridge University and Institute for Child Health, University of London

4.4.
4.5.
4.6.
As Co-Investigator
5 Publications Types of publications g. Original scientific papers in peer-review journals h. Peer reviewed articles and book chapters i. Papers in conference proceedings j. Letters, editorials, annotations, and abstracts in peer-reviewed journals k. Working papers l. Monographs Numbers 85 1 14 64 18
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1) 1) Watson J.F., Collins C.E., Sibbritt D.W., Dibley M.J., Garg M.L. Reproducibility and comparative validity of a food frequency questionnaire for Australian children and adolescents. International Journal of Behavioral Nutrition and Physical Activity 2009, 6:62 doi:10.1186/1479-5868-6-62
Cheng Y., Dibley M.J., Zhang X., Zeng L., Yan H. Assessment of dietary intake among pregnant women in a rural area of western China. BMC Public Health. 2009 July 9; 9:222. PMID: 19589154
2) 3) Ramli, Agho KE, Inder KJ, Bowe SJ, Jacobs J. and Dibley MJ. Prevalence and risk factors for stunting and severe stunting among under-fives in North Maluku province of Indonesia Submitted to BMC Public Health accepted August 2009.
Trang, N.H.H.D., Hong, T.K., Dibley, M.J., Sibbritt, D.W. Factors associated with physical inactivity in adolescents in Ho Chi Minh City, Vietnam. Medicine and Science in Sports and Exercise 2009, 41 (7), pp. 1374-1383
4)
5) Hong, T.K., Dibley, M.J., Sibbritt, D.W. Validity and reliability of an FFQ for use
with adolescents in Ho Chi Minh City, Vietnam. Public Health Nutrition, September 2009, doi: 10.1017/S136898000999125X

1 2 3
Name: Dr. S. K. Roy Present Position: Senior Scientist Educational background:

FRCP Ph.D in Nutrition Certificate on Food, Nutrition, Biotechnology & poverty
2008 1987-1990 1984 - 1985 University of London London School of Hygiene and Tropical Medicine, UK & UNU
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M.Sc. in Human Nutrition MBBS
1983-1984 1973
London School of Hygiene and Tropical Medicine, UK Dhaka Medical College, University of Dhaka

4.7.
Protocol Number 2006-45 2008-003 PR-09014 Starting date 1st February 2007 15 May 2008 1st October 2009 End date 30 November 2007 10 months after approval 30 September 2010 Percentage of time
4.8.
4.9.
As Co-Investigator
5 Publications Types of publications m. Original scientific papers in peer-review journals n. Peer reviewed articles and book chapters o. Papers in conference proceedings p. Letters, editorials, annotations, and abstracts in peer-reviewed journals q. Working papers r. Monographs Numbers 65 9 36
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1. Roy SK, Khatun W, Azim T, Raqib R, Chakraborty B. Synergistic effect of vitamin A and zinc on nutritional status and growth in 6-36 months age group. In: proceedings of the symposium on Nutrition in late infancy and early childhood (6-24 months), Nutrition Foundation of India. 2006 2. Roy S K, AM Tomkins, SM Akrauzzman, KE Islam, G Ara, W Khatun, S P Jolly. Impact of Zinc supplementation on subsequent morbidity and growth in Bangladeshi children with persistent diarrhoea. J Health Popul Nutr 2007 Mar;25(1):67-74 3. Roy SK, Raqib R, Khatun W, Azim T, Chowdhury R, Fuchs GJ, Sack DA. Zinc supplementation in the management of shigellosis in malnourished children in Bangladesh. EJCN March 2007; 1-7 4. Roy SK, Hossain M.J, W.Khatun, Chakraborty B, Chowdhury S, Begum A, Muneer SME, Shafique S, Khanam M, Chowdhury R. Zinc supplementation in children in cholera in Bangladesh: Randomised controlled trial; BMJ January 2008: online publication. 5. Roy SK, Jolly S P, Shafique S, Fuchs G J, Mahmud Z, Chakraborty B, and Roy S. Prevention of malnutrition among young children in rural Bangladesh by a foodhealthcare educational intervention: A randomized controlled trial; Food and Nutrition Bulletin; January 2008; vol 28 (4); 375-383.

1 2
Name: Seema MIHRSHAHI Present Position: October 2009

Heinz Postdoctoral Research Fellow Institute of Biomedical Innovation (IHBI) School of Public Health Queensland University of Technology Kelvin Grove 4059 Australia
Educational background:
Masters in Public Health, University of Sydney, 1999 Coursework & treatise: International Health/Disease Prevention. MPH Treatise: Effectiveness of allergen avoidance in infancy PhD, Curtin University of Technology, 2007 International Health Thesis topic: Exclusive breastfeeding and child morbidity in developing countries
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4.10.
4.11.
4.12.
As Co-Investigator
5 Publications Types of publications a. Original scientific papers in peer-review journals b. Peer reviewed articles and book chapters c. Papers in conference proceedings d. Letters, editorials, annotations, and abstracts in peer-reviewed journals e. Working papers f. Monographs Numbers 26 3 39 39
1) Casey GJ, Phuc TQ, Macgregor L, Montresor A, Mihrshahi S, Thach TD, Tien NT, Biggs
BA. A free weekly iron-folic acid supplementation and regular deworming program is associated with improved hemoglobin and iron status indicators in Vietnamese women. BMC Public Health. 2009;9:261.
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2) Mihrshahi S, Oddy WH, Peat JK, Kabir I. Association between infant feeding patterns and diarrhoeal and respiratory illness: A cohort study in Chittagong, Bangladesh. Int Breastfeed J. 2008; 24;3:28. 3) Mihrshahi S, Ichikawa N, Shuaib M, Oddy W, Ampon R, Dibley MJ, Kabir AKMI, and Peat JK Prevalence of exclusive breastfeeding in Bangladesh and association with diarrhoea and acute respiratory infection: results of the Multiple Indicator Cluster Survey (MICS), Journal of Health, Population and Nutrition 2007;25(2):195-204. 4)Mihrshahi S, Ampon R, Webb K, Almqvist C, Kemp AS, Hector D, Marks GB; CAPS Team. The association between infant feeding practices and subsequent atopy among children with a family history of asthma. Clin. Exp. Allergy. 2007; 37(5):671-9. 5)Mihrshahi S, Casey GJ, Montresor A, Phuc TQ, Thach DT, Tien NT, Biggs BA. The effectiveness of 4 monthly albendazole treatment in the reduction of soil-transmitted helminth infections in women of reproductive age in Viet Nam. Int J Parasitol. 2009;39(9):1037-43.

Name: Kingsley Emwinyore Agho
2 Present Position: Research Fellow in Biostatistics, School of Medicine The University

of Western Sydney, Australia.
Educational background: Doctor of Philosophy, University of Technology,

Sydney

4.13.
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4.14.
4.15.
As Co-Investigator
5 Publications Types of publications s. Original scientific papers in peer-review journals t. Peer reviewed articles and book chapters u. Papers in conference proceedings v. Letters, editorials, annotations, and abstracts in peer-reviewed journals w. Working papers x. Monographs Numbers 35 4 13 2 2 1
1) Ramli, Agho K, Inder K, Bowe SJ, Jacobs J and Dibley MJ: Prevalence and risk factors for stunting and severe stunting among under-fives in North Maluku province of Indonesia. BMC Pediatrics 2009, 9 (1):64. 2) Titaley, CR., Dibley, MJ., Agho, K., Roberts, CL and Hall, J: Determinants of Neonatal Mortality in Indonesia. BMC Public Health. 2008 Jul 9;8(1):232. 3) Agho, K., Dibley, MJ, DEste, C and Gibberd, R: Factors associated with Hb concentration among Timor-Leste children aged 6-59 months. Journal of Health, Population and Nutrition 2008 26 (2):200-9. 4) Senarath, U., Dibley, MJ & Agho, K: Breastfeeding practices index: a composite index to describe overall breastfeeding performance among infant under 6 months of age. Journal of Public Health Nutrition 2007 10(10):996-1004. 5) Agho, K., Dai, W & Robinson, J: Empirical Saddlepoint Approximations of the Studentized ratio and Regression Estimates for Finite Population. Statistics and Probability Letters. 2005. 71 (3): 237247.
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1 Name: ANADIL ALAM 2 Present Position:. Research Investigator Health system and economics unit, HSID, International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B).
Educational background: M.B.B.S 1994

4.16.
4.17.
4.18.
As Co-Investigator
5 Publications Types of publications y. Original scientific papers in peer-review journals z. Peer reviewed articles and book chapters aa. Papers in conference proceedings Numbers 3 1 45
bb. Letters, editorials, annotations, and abstracts in peer-reviewed journals cc. Working papers dd. Monographs
1. Khairun Nessa, Shama-A-Waris, Anadil Alam, Mohsina Huq, Shamsun Nahar, Faisal Arif Hasan Chawdhury, Shirajum Monira, Monir Uddin Badal, Jinath Sultana, Kazi Faisal Mahmud, Joseph Das, Dipak Kumar Mitra, Zafar Sultan, Najmul Hossain and Motiur Rahman. (2004) Sexually transmitted infections (STIs) among brothel-based Sex Workers (SWs) in Bangladesh: high prevalence of asymptomatic infection. Sexually Transmitted Diseases. Sexually Transmitted Diseases, Jan 2005, Vol.32, No.1. p. 13-19 2. Khairun Nessa, Anadil Alam, Faisal Arif Hasan Chawdhury, Mohsina Huq, Shamsun Nahar, Gazi Salauddin, Shayema Khursheed, Saifur Rahman, Emily Gurley, Robert F Brieman, Motiur Rahman. Field evaluation of simple rapid tests in the diagnosis of syphilis, Excepted in the Journal of STD and AIDS
Budget Justifications
Please provide one page statement justifying the budgeted amount for each major item, including the use of human resources, major equipment, and laboratory services.
PI: Will spent 25% of time and be responsible for overall design, defending the proposal at institutional review committees, coordination with relevant persons and departments, training of staff, monitoring of quality and progress, checking at least 5% data in the field, and in data analyses and report writing. Co-Principal Investigators: The co-principal investigator will help in the design, training, actual conduct of the survey, quality control, data analysis and report writing. One of them will lead the QC data collection in the field
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Statisticians/ Data Analyst: The Statistician/Data analyst will supervise Data Management Assistant and assign daily tasks to data entry staff. S/he will provide required support to the scientific staff, and assuring quality output on a regular basis as planned. Program Manager: One full time senior manager is needed to keep track of progress in all sectors and coordination of such a large survey work. S/he will organize work schedules, ensures logistics support, manages financial transaction, supervise for QC in field team coordination, training in QC, questionnaire development and conducting workshops, process and analyze data collected from field surveys, make literature search of relevant researches, liaison in organization of work within office and other offices, check data entry cleaning & prepare analytical tables and figures. Research Officer: S/he will work full time to organize work schedules, participates and supervises and coordinates QC field teams gives training in QC, organizes questionnaire development, field testing process and analyze data collected from field surveys, literature search , organization of work within office, check data entry, cleaning & draft data tables and figures. Data Management Assistant: S/he will organize data entry activity with reference to data collection procedures, prepare documentation of data files with code plan, ensure data file backup on a regular basis. S/he will prepare code plans, edit plans, carry out consistency checks, and ensure daily/weekly data backup. Will also assist analysis of data. Office Attendant: S/he will assists the Project Office Management Team to provide its day-to-day logistics support services i.e xerox needs, carrying supplies, handles different office machines e.g. xerox machine, spiral binder, etc., keep offices clean and in order. S/he will be responsible to arrange the meeting/seminar rooms and keeps materials in its places as per plan arrange logistics for meetings and to respond all other meeting needs i.e. photocopying, switch adjustments, or transporting overhead/power point etc. Secretary: Secretary will prepare documents and help tying and liaison with departments for HR issues and smooth supply and procurement, prepare and organize documents for staff and field related communication. Keep records for financial transactions and follow up communications and decisions. Field research Officer: The post holder is responsible to supervise the activities to maintain the quality of service and data collection. S/he is responsible to identify the training need of the staff and conduct/organize training. S/he is responsible to review the field activities and prepare report.
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The position holder is needed to edit the collected data independently and ensure completion, consistency and accuracy of the collected data. S/he is responsible for field administration, managing leave, checking the bills etc. The position holder is responsible to maintain liaison with the community and senior staff of the project. Field Research Assistant: S/he will carry out fieldwork independently or jointly for collecting data at a satisfactory quality. S/he will be, responsible for editing, coding and crosschecking of the data in the field.
Other Support
Describe sources, amount, duration, and grant number of all other research funding currently granted to PI or under consideration.
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Check-List
CHECK-LIST FOR SUBMISSION OF RESEARCH PROTOCOL FOR CONSIDERATION OF RESEARCH REVIEW COMMITTEE (RRC) [Please check (X) appropriate box]
1. Has the proposal been reviewed, discussed and cleared at the Division level? Yes If No, please clarify the reasons: 2. Has the proposal been peer-reviewed externally? Yes No No
If the answer is No, please explain the reasons: If yes, have the external reviews comments and their responses been attached Yes 3. No
Has the budget been cleared by Finance Department? Yes No
If the answer is No, reasons thereof be indicated: 4. Does the study involve any procedure employing hazardous materials, or equipments? Yes If Yes, fill the necessary form. 5. Has the Ethics Certificate(s) been attached with the Protocol? Yes No No
If the answer is No, please explain the reasons:
_______________________________ Signature of the Principal Investigator
_________ Date
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INFORMATION TO INCLUDE IN ABSTRACT SUMMARY

The Ethical Review Committee will not consider any application that does not include an abstract summary. The abstract should summarise the purpose of the study, the methods and procedures to be used, by addressing each of the following items. If an item is not applicable, please note accordingly: 1. Describe the requirements for a study population and explain the rationale for using in this special population groups such as children, or groups whose ability to give voluntary informed consents might be compromised. 2. Describe and assess any potential risks physical, psychological, social, legal or other, and assess their likelihood and seriousness. If research methods are anticipated to create potential risks, describe alternate methods, if any, which were considered and why they will not be used. 3. Describe procedures for protecting against or minimizing potential risks and an assessment of their likely effectiveness. 4. Include a description of the methods for safeguarding confidentiality and protecting anonymity. 5. When there are potential risks to the subject, or the privacy of the individual may be affected, the investigators are required to obtain a signed informed consent from the prospective participant.For minors and individuals with compromised ability to provide a valid consent, informed consent must be obtained from their parents or legal guardians. Describe consent procedures to be followed including how and where informed consent will be obtained. a) If signed consent will not be obtained, explain why this requirement should be waived and provide an alternative procedure that would be used. b) If information is to be withheld from a subject, provide justification for this course of action. c) If there is a potential risk to the participant or privacy of the individual might be affected while applying any particular procedure include a statement in the consent form to clarify whether or not compensation and/or treatment will be available. 6. If study involves an interview, describe the place and processes, and state the approximate length of the interview. 7. Assess the potential benefits to be gained or risk the individual participants might be subjected to, and also the benefits that might accrue to the society in general as a result of the planned work. Clarify if and how the benefits outweigh the risks. 8. State if the activity requires the use of records (hospital, medical, birth, death or other), organs, tissues, body fluids, the foetus or the abortus. The statement to the potential participants should include information specified in item 2,3,4,5(c) and 7, and also indicate the approximate time they would be required to remain in the activity.
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Detailed Budget for the study titled: Name of Principal Investigator: Protocol Number: Division: Funding Source: Budget: Study period: Strategic Priority Code(s): Details Budget:
Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Dr. A. K. M. Iqbal Kabir PR#10001 CSD National Health & Medical Research Council (NHMRC), Australia Total: Au$_912,488 From:_2010_ through__2014 1.5 & 3.3
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APPLICANT RESPONSE
Application ID: 633229
We thank the Assessors for their positive review of our proposed cluster randomized controlled trial of peer counseling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh. We agree with the assessment that the significant innovation in our proposal is the extension of a peer-counseling approach to integrate all the key infant and young child feeding messages in a single program of support and promotion of appropriate feeding from pregnancy through the first of life. We welcome the opportunity to respond to the Assessors questions below. Will 13 peer counsellor visits will be sufficient to achieve the outcomes? (Assessor 1) We understand the concern of the assessor in questioning the intensity of the intervention if the number of peer counselor visits is reduced from the earlier trial in which only breastfeeding was promoted. We have therefore modified the proposal to expand the peer counselor contacts with mothers to monthly visits until nine months (see description below). However less frequent peer counselor contacts with mothers have been used in other research projects conducted by CIB and yet resulted in an adequate response1. We carefully considered the number of contacts when designing the trial because we wanted to test an intervention that was replicable and sustainable in the future and thus we restricted the total number of contacts. However we plan to train the counselors to be flexible and to increase their contacts if the mother needs additional support (or the reverse if mother needed less support). Micronutrients and complementary feeding interventions (Assessor 2) We agree with the comment by Assessor 2 that adequate micronutrient intake is required for appropriate child growth. The rationale for our use of a food-based intervention was to ensure that both the energy density and micronutrient content of the complementary feeds would be improved in a sustainable way. We realize that the description of the complementary feeds that would be promoted by the peer counselors lacked sufficient detail and we have expanded this in the section on modifications to the protocol below. The approach we will use has been previously evaluated by CIE and found to result in significant impact on growth2. There is strong evidence from a systematic review that education interventions about appropriate complementary feeding do improve child growth3 . Interestingly this systematic review found a smaller growth response from home micronutrient fortification (sprinkles or crushable tablets) than education interventions. Although we think that multiple micronutrients are needed for adequate growth, the evidence indicates that food-based interventions are able to deliver these nutrients even in poor communities provided adequate knowledge, encouragement and support is available in the community. How to deal with attrition and will it be higher than 22%? (Assessor 1 & 3) We would have no difficulty with expanding the sample size if we found a higher attrition rate in the pilot study than was assumed when calculating the sample size. We have calculated the subject attrition rate from birth till the infant was 12 months of age for the pilot study described in the research plan, and found it was only 23%. Thus we think our estimates for attrition are reasonable. However we would be more concerned about compromised validity of the trial if the attrition rate was much higher then 20% to 25%. We will therefore actively engage the cohort of mothers by regular group meetings to talk about the study and identify any problems they may be experiencing. We would also use mobile phones to Minimat Study conducted in Matlab where there were 2 counseling sessions during pregnancy, then 5 more until the baby was six months old and this resulted in an exclusive breast feeding rate of 50% in the BF counseling group compared to only 27% in the control group. Presented at Pediatric Academic Societies meeting in Baltimore, May 2-5, 2009 2 Roy SK, et al. Food and Nutrition Bulletin, 28 (4): January 2008: 375-383. 3 Dewey K et al Web Appendix 3 Systematic review of the efficacy & effectiveness of complementary feeding interventions in developing countries. In Bhutta ZA, et al. (2008) What works? Interventions for maternal and child undernutrition and survival. Lancet 371: 417-440.
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keep in contact with families, and we would collect multiple family contacts at the start of the trial to ensure we had more than one avenue to search for the participants if needed for follow up assessments. These approaches could be used for both the control and intervention groups. Contamination can it be reduced and monitored? (Assessor 1) Contamination of the intervention into the control group population is always an important concern of investigators conducting community-based health promotion trials. We think that the risk of contamination is low because the social networks are weaker in urban populations. Each Mahalla is approximately 1 Km2 and has over 2000 to 3000 households. We will map each Mahalla and divide it into a central zone with 75% of the households from where the women for the trial will be recruited, thus effectively creating a buffer zone4 to reduce contamination. Why three monthly follow-up? What cost savings and trade-offs would be involved in reducing the frequency of follow-up? (Assessor 1) Reducing the follow up frequency is unlikely to result in substantial cost savings especially if it was limited to just two follow up visits at 9 and 15 months. The risk would be more missing data and less data to describe longitudinal changes in growth. CIs experience leading large scale epidemiological studies (Assessor 1) CIA, CIB and CIC have all had experience in either directly managing or facilitating large scale epidemiological studies that involve multidisciplinary teams and require active engagement of government and non-government stakeholders. CIA has done this in cross cultural settings (relative to his Anglo-Australian background) including in Indonesia, China, Vietnam and India. CIB and CIC have worked closely with BRAC a large NGO in Bangladesh on both research and development projects. Data management, quality control systems & data transfer across countries (Assessor 1 & 2) CIA has had substantial experience is setting up data management systems for international field trials. He would work with the data manager (PRP4) and CIB and CID to prepare manuals of operations, establish the data entry, data cleaning and monitoring processes. A web-based data entry system would be used and both research groups at the University of Sydney and ICDDR,B have had prior experience in using these systems. Justification of the time fractions requested for CIB and CIE (Assessor 1) CIB will allocate 50% effort for managing the field trial. This level of effort is essential to ensure a successful outcome in any complex community based trial where daily supervision and monitoring of staff and activities is required. Any lower level of effort would risk compromising the implementation of the study interventions and the quality of the evaluation data. CIE brings important experience in developing and putting into operation an intervention study on complementary feeding. He also has strong links with key government and NGO stakeholders and his networks will greatly facilitate the implementation of the project. The allocation of 10% effort for this project is sufficient for these tasks which do not overlap with the more intensive field work required of CIB. Justification for int. travel, especially for CIB & CIE to visit Australia in YR 4 (Assessor 1) International collaborative research requires cross country contact to be successful. Although phone, email and internet connections will also be important to support effective management of the project, face-to-face contact is essential when developing research instruments, establishing project management systems, monitoring the quality of data collection, conceptualizing analysis plans and conducting analyses. It is not possible to equitably conduct international collaborative research without the participation of in-country partners in the data analysis and this is the rationale for their visits to Australia in year four of the project. Appropriateness of dietary assessment methods (Assessor 2) Design Issues, Strategies to reduce contamination, pp58 in Hayes RJ, Moulton LH. Cluster Randomised Trials. Chapman & Hall/CRC 2009
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The proposed dietary assessment methods are appropriate because the analysis will examine the group means for each treatment group. . Competitive position of the research group relative to other international nutrition/health groups working in South Asia (Assessor 2) All the CIs have worked together as part of the South Asian Infant Feeding Research Network (SAIFRN) which was established by CIA to address the lack of research being conducted in South Asia on infant and young child feeding, despite the large burden of disease from child malnutrition in the region. CIA was faculty of the Department of International Health at the Johns Hopkins University for seven years and has close professional relationships with their international nutrition staff. The JHU staff have focused their research on micronutrient interventions which are being conducted in Nepal and Bangladesh and not on infant and child feeding interventions. The ICDDR,B is one of the global leaders in research on child nutrition and health in developing countries and does not need to be benched marked against US universities. Our research team is internationally competitive and has conceptualized an innovative research project that can potentially provide important evidence to guide nutrition programs in South Asia. Justify why adverse events are not being monitored (Assessor 2) We will not have sufficient statistical power to examine the effect of the intervention on child mortality. Child morbidity will be balanced across treatment groups by randomization. Measurement of morbidity would add considerable complexity and costs tot eh trial. The close contact required might result in a non-specific study effect as a consequence of the close contact required that would reduce the differences between the treatment groups. Why the focus on stunting rather that underweight? (Assessor 3) We plan to measure weight and height, and report all three indicators (underweight, stunting, and wasting) since they measure and reflect different aspects of child malnutrition. Stunting (low height for age) is currently the best measure for assessing the cumulative deficient growth associated with longterm dietary insufficiency and recurrent illness. Wasting (low weight for height) indicates in most cases recent acute weight loss from food shortage or an acute severe disease. Underweight (low weight for age) is influenced both by linear growth as well wasting. Its composite nature complicates its interpretation. The best long term indicator of improved nutrition and health is stunting and this has been widely used in evaluations of infant feeding interventions3. Team make-up (Assessor 3) The team could benefit from further diversity and we have reached an agreement to work collaboratively with Sabrina Rasheed Ph.D. Assistant Scientist, Social and Behavioral Sciences Unit, ICDDR,B. She is social scientist and nutritionist with an interest in the social processes influencing family decisions about infant feeding. She will work closely with the team during the development of the intervention, and with the training of the peer counsellors. Modifications to the proposal in response assessor questions or comments The following items have been added to the proposal in response to points raised by the assessors. Intervention schedule The peer counseling contacts will be monthly from 2 until 9 months. Description of complementary feeds to be promoted by peer counselors The two types of complementary feeds to be promoted are based on prior survey of foods given to young children in urban Dhaka. The first will be rice-suzi (powdered rice + soybean oil to make it energy dense), and the second will be Khichri (cooked rice + lentil + soybean oil). For both traditional feeds the mothers will be encouraged to add animal protein, mashed vegetables including green leafy vegetables, and some seasonal fruits to improve the micronutrient diversity of the feeds. Mothers will also be discouraged from using bottles for feeding
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Diversifying the team We have added Dr Sabrina Rasheed, a health social scientist with an interest in infant and young child feeding.
Ethics Certificate of Dr. A.K. M. Iqbal Kabir
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Ethics Certificate of Dr. S. K. Roy
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Ethics Certificate of Dr. Anadil Alam

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Consent Form (18-45)
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Protocol Number: _10001___________________________________________________________ Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Investigators name: Dr. A. K. M. Iqbal Kabir
Organization: _ICDDR,B Purpose of the research Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 54% of child deaths and 11% of the total global disease burden. Appropriate IYCF have been found to reduce one fifth of child death and prevent malnutrition. To date there have been no interventions that include peer-counselling to improve infant feeding practices over the first 18 months of life. The potential intensity and duration of the intervention is likely to result in a reduced rate of malnutrition and will be of great interest to public health planners in developing countries. It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.
Why are we inviting you to participate in the study? We are inviting you to participate in this study because your cooperation to the study may help to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children. What is expected from the participants of the research study?
If you agree to our proposal of enrolling you in the study, we will ask you some questions about socio-
economic status, current breastfeeding status, current use of other liquids and solid foods, timing of introduction of other liquids or solid foods, use of bottles for feeding and information about who is providing advice about infant feeding amongst family and friends, collect 24-hr dietary recalls that your child usually take within 24 hours. We will also measure his/her weight and height as well as mid upper arm circumference and measure your child food which your will eat within 24 hours. The completion of all processes may need about one hour of your time.
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Risk and benefits There is no risk from participating in this study involving any procedure, which may harm you. In fact, you may know more about your nutritional status and related information if you ask us. If you help in this study by giving some time, the research will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. Privacy, anonymity and confidentiality We will keep all of your information strictly confidential, and none other than the staff of our study and the Ethical Review Committee of ICDDR,B that protects the interest of research participants will have an access to your information. If you wish we will inform you any results of your own. Future use of information If the results are found as anticipated, the module of peer counselling intervention program will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh.
Right not to participate and withdraw
Your participation in this study is absolutely voluntary i.e. you are the one to decide for and against participation. You may also decide not to respond to any or all questions that we will ask you. You would also be able to withdraw your consent at any time during the study period. If you do not participate and if you withdraw your participation after initial enrolment, you would continue to receive the standard care and treatment of the Dhaka Hospital of ICDDR,B in future.
Principle of compensation
Your participation in this study is absolutely voluntary. We will not be able to give you any compensation for participation in this study. If you have any question regarding your health aspects, or about our study, you may ask us now or in future. You will also be able to contact the principal investigator of this research study, Dr. Iqbal Kabir, at the Dhaka Hospital of ICDDR,B, Mohakhali, Dhaka-1212 personally or communicate him over telephone 8860523-32 (extension number 2312)) or Mobile phone No:01730095515. If you want to know more about your rights as a participant in a research study or related issues you may contact Mr. M. A. Salam, Manager, IRB Secretariat, RA, ICDDR,B, Mohakhali, Dhaka-1212 personally or
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communicate with him at the following telephone number: 8860523-32 (extension number 3206) or direct: +880-2-9886498.
If you agree to our proposal of enrolling you/your patient in our study, please indicate that by putting your signature or your left thumb impression at the specified space below Thank you for your cooperation _______________________________________ Signature or left thumb impression of subject ____________________ Date
_______________________________________ Signature or left thumb impression of attendant/Guardian _______________________________________ Signature or left thumb impression of the witness
____________________ Date
____________________ Date
_______________________________________ Signature of the PI or his/her representative
___________________ Date
(NOTE: In case of representative of the PI, she/he shall put her/his full name and designation and then sign) (Name and contact phone of IRB Secretariat, RA, M. A. Salam Khan, phone: 9886498 or PABX 8860523-32 ext. 3206).
Consent Form (Bangla)

(18-45 years)
72
MelYvi bî: 10001 MelYvi bvg: evsjv`ki 0-2 eQii wkì Lv`vfvmi Dbqb Ges Acyw `~ixKibi Rb mZx_ civgk `vb cavb MelK: W: G.K.BKevj Kwei ms&v: AvRvwZK D`vivgq MelYv K`, evsjv`k |
MelYvi Dk:
Dbqbkxj `ki ga evsjv`ki wkì ga Acywi ecKZvi nvi cej| cixvq `Lv wMqQ h h_vh_ AvBIqvBwZGd viv 1/5 wk gZz nvi KgQ Ges Acyw `~ixKib iyZc~iY fywgKv ivL| 54% wk gZz Ges 11% wewfb aibi AmyLi cavb Kvib GB Acyw| 18 gvmi wk Lv`vfvm DbZ Kivi Rb eZgvb Kvb aibi civgk Kvhg wekl Ki mZx_ civgk Pvjy bB| civgk Kvhgi mydj Ges civgk `vbi Dchy mgq Avgvì `ki Acyw `~ixKib iyZc~iY fywgKv ivLe| Dbqbkxj `ki RbmsLv cwiKbvKvixì Rb GwU GKwU AZ AvKlbxq cwiKbv nZ cvi| Avkv Kiv hvq GB Melbv nZ cv djvdj cKvwkZ nj wkì ^vi Dci iZc~ib cfve dje| `wY Gwkqvi wkì Rb Rb^v I cyw welqK cwiKbvi Dbqb Kiv hve, hvi viv wkì ^vI DbwZZ ecK f~wgKv ivLe| Kb GB MelYvq Afy nIqvi Avnvb Rvbvbv nQ? AvcbvK GB MelYvi Afy nIqvi Avnvb Rvbvbv nQ KviY Avcbvi mnhvMxZvi Rb mwVKfve gvZ`y `vb I wki cwic~iK Lv` MnYi gvag Lv`fvm Dbqb, wki ew Ges Acywi ecKZvK iva KiZ mvnvh Kie| ivMx/Di`vbKvixi wbKU nZ wK Avkv Kiv hvq? Avcwb hw` GB MelYv KvR AskMnb KiZ mZ nb Ze Avgiv AvcbvK Avcbvi Av_ mvgvwRK Aev, wki Rb eZgvb Zij I k Lvevii eev, k ev Zij Lvevi i Kivi mgq, `y`vbi Rb evZji eenvi mK wKQy ck Kie| Avgiv AviI RvbZ PvBe h cvwievwiK I cvovcwZkx v Avxq bq Ggb Kn AvcbvK beRvZKi Lv`vfvm mK Dc`k w`qQ Ges MZ 24 NUvq KZevi wkwU Lv` Mnb KiQ| Avgiv Avcbvi IRb I DPZv Ges Avcbvi wki IRb, `N, ga evi cwigvcGes 24 NUvq m h Lv` Mnb Ki Zv cwigvc Kie| GB cyiv cwqvwUi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne| Avgiv AvcbvK m^wjZ AvjvPbvZ AskMnb Kivi Rb Avgb hvbvwQ | GB AvjvPbvZ AskMnb Kivi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne| SzuwK Ges DcKvixZv:GB MelYv Kvhi mv_ hy nj Zgb Kvbv wZ nevi mvebv bB , eis GB MelYvq AZfy nj Avcwb v Avcbvi wkkyi Avcbvi eZgvb cywMZ Aev Ges G mwKZ h Kvbv Z_ RvbZ cvieb| hw` GB Melbv Kvhg Avcwb AvgvìK mvnvh Kib Ze Zv mZx_ AskMnb cvMvgwU Dchy cgvb
73
wnme mwVKgvZ`y `vb I cwic~iK Lv`vfvm Zwii gvag Acyw `yixKib evsjv`ki ki wkì mvnvh Kie| MvcbxqZv ivq cwZkwZ:Avcbvi h Kvbv Z_ Avcwb eZxZ mKji wbKU Mvcb ivLv ne| Z_mg~n AvBwmwWwWAviwei KwDUvi msiwZ _vKe| Avcbvi wbRi mK h Kvbv Z_ RvbZ PvBj Avgiv AvcbvK Zv RvbvZ eva| fwelZ eenvii Rb Z_:hw` cv djvdj Avkvbyic nq, Ze mZx_ AskMnb cvMvgwU Dchy cgvb wnme mwVKgv`y `vb I cwic~iK Lv`vfvm Zwii gvag Acyw `yixKib evsjv`ki ki wkì mvnvh Kie| AskMnY AwbQv ev ev` `qvi AwaKvi: Avcbvi MelYv KvR AskMnY cyivcywi Avcbvi Dci wbfikxj| Avcwb PvBj AskMnb KiZ cvib A_ev weiZ _vKZ cvib| hKvb cki Di bvI w`Z cvib| PvBj hKvb mgq MelYvq AskMnY cwinvi KiZ cvib| MelYv Kvh AskMnY bv KiZ PvBjI Avcwb AvBwmwWwWAviwe KZK c` DbZ mev Ges wPwKrmv jvf Kieb| wZc~iY:Avcbvi GB MelYv Kvh AskMnb m~Y Avcbvi BQvi Dci wbfikxj| AskMnYi Rb Kvb wZc~iY `qv ne bv| hw` Avcbvi ^v mwKZ Kvb wRvmv _vK Ze Zv GLb ev fwelZ MelYv PjvKvjxb mgq KiZ cvieb|G Rb Avcwb cavb MelK W: W: G.K.BKevj Kweii mv_ hvMvhvM KiZ cvib| gnvLvjxi AvBwmwWwWAviwe , XvKv nvmcvZvj mivmwi hvMvhvM KiZ cvib ev 8860523(G. 2312) ev 017130095515 bv^vi K_v ejZ cvib| GQvovI Avcbvi AwaKvi mwKZ Kvb wRvmv _vKj Avcwb wg. Gg G mvjvg, gvbRvi, AvBAviwe mUvixqU, AviG, AvBwmwWwWAviwe, gnvLvjx, XvKv-1212, Gi mv_ hvMvhvM KiZ cvib ev Awdm bv^vi 8860523-32 (G.3206) ev+880-2-9886498 bv^vi K_v ejZ cvib| hw` G mKj kZ Avcwb/Avcbvi ivMx GB MelYv Kvh AskMnY KiZ Pvb, Ze AbyMn Ki wbPi wPwZ Ask Avcbvi `LZ ev Avyji Qvc c`vb Kib| mnhvwMZvi Rb AvcbvK abev`| AskMnYKvixi `LZ ev Avyji Qvc
ZvwiL
74
AskMnYKvixi mv_ AvMZ AwffveK `LZ ev Avyji Qvc mvvrKvi MnYKvixi `LZ cavb MelKi `LZ
ZvwiL
ZvwiL
ZvwiL
(Kvb Kvib cavb MelK AbycwZ _vKj Zvi cwZwbwai bvg , `LZ) { KwgwU m^^q mUvixi bvg I dvb bv^vi :Gg G mvjvg Lvb, dvb 9666498(WvBi), wcGweG 8860523-32,G3206}
Assent Form
(15-17 years)
Protocol Number: 10001 Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Investigators name: Dr. A. K.M. Iqbal Kabir
Organization: ICDDR,B Purpose of the research Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 54% of child deaths and 11% of the total global disease burden. Appropriate IYCF have been found to reduce one fifth of child death and prevent malnutrition. To date there have been no interventions that include peer-counselling to improve infant feeding practices over the first 18 months of life. The potential intensity and duration of the intervention is likely to result in a reduced rate of malnutrition and will be of great interest to public health planners in developing countries. It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.
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Why are we inviting you to participate in the study? We are inviting you to participate in this study because your cooperation to the study may help to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children. What is expected from the participants of the research study?
If you agree to our proposal of enrolling you in the study, we will ask you some questions about socio-
economic status, current breastfeeding status, current use of other liquids and solid foods, timing of introduction of other liquids or solid foods, use of bottles for feeding and information about who is providing advice about infant feeding amongst family and friends, collect 24-hr dietary recalls that your child usually take within 24 hours. We will also measure his/her weight and height as well as mid upper arm circumference and measure your child food which your will eat within 24 hours. The completion of all processes may need about one hour of your time. Risk and benefits There is no risk from participating in this study involving any procedure, which may harm you. In fact, you may know more about your nutritional status and related information if you ask us. If you help in this study by giving some time, the research will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. Privacy, anonymity and confidentiality We will keep all of your information strictly confidential, and none other than the staff of our study and the Ethical Review Committee of ICDDR,B that protects the interest of research participants will have an access to your information. If you wish we will inform you any results of your own. Future use of information If the results are found as anticipated, the module of peer counselling intervention program will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh.
Right not to participate and withdraw
76
Your participation in this study is absolutely voluntary i.e. you are the one to decide for and against participation. You may also decide not to respond to any or all questions that we will ask you. You would also be able to withdraw your consent at any time during the study period. If you do not participate and if you withdraw your participation after initial enrolment, you would continue to receive the standard care and treatment of the Dhaka Hospital of ICDDR,B in future.
Principle of compensation
Your participation in this study is absolutely voluntary. We will not be able to give you any compensation for participation in this study. If you have any question regarding your health aspects, or about our study, you may ask us now or in future. You will also be able to contact the principal investigator of this research study, Dr. Iqbal Kabir, at the Dhaka Hospital of ICDDR,B, Mohakhali, Dhaka-1212 personally or communicate him over telephone 8860523-32 (extension number 2312)) or Mobile phone No:01730095515. If you want to know more about your rights as a participant in a research study or related issues you may contact Mr. M. A. Salam, Manager, IRB Secretariat, RA, ICDDR,B, Mohakhali, Dhaka-1212 personally or communicate with him at the following telephone number: 8860523-32 (extension number 3206) or direct: +880-2-9886498.
If you agree to our proposal of enrolling you/your patient in our study, please indicate that by putting your signature or your left thumb impression at the specified space below Thank you for your cooperation _______________________________________ Signature or left thumb impression of subject ____________________ Date
_______________________________________ Signature or left thumb impression of attendant/Guardian _______________________________________ Signature or left thumb impression of the witness
____________________ Date
____________________ Date
_______________________________________ Signature of the PI or his/her representative
___________________ Date
77
(NOTE: In case of representative of the PI, she/he shall put her/his full name and designation and then sign) (Name and contact phone of IRB Secretariat, RA, M. A. Salam Khan, phone: 9886498 or PABX 8860523-32 ext. 3206).
Assent Form (Bangla)

(15-17 years) MelYvi bî: 10001 MelYvi bvg: evsjv`ki 0-2 eQii wkì Lv`vfvmi Dbqb Ges Acyw `~ixKibi Rb mZx_ civgk `vb cavb MelK: W: G.K.Gg.BKevj Kwei ms&v: AvRvwZK D`vivgq MelYv K`, evsjv`k |
MelYvi Dk:
Dbqbkxj `ki ga evsjv`ki wkì ga Acywi ecKZvi nvi cej| cixvq `Lv wMqQ h h_vh_ AvBIqvBwZGd viv 1/5 wk gZz nvi KgQ Ges Acyw `~ixKib iyZc~iY fywgKv ivL| 54% wk gZz Ges 11% wewfb aibi AmyLi cavb Kvib GB Acyw| 18 gvmi wk Lv`vfvm DbZ Kivi Rb eZgvb Kvb aibi civgk Kvhg wekl Ki mZx_ civgk Pvjy bB| civgk Kvhgi mydj Ges civgk `vbi Dchy mgq Avgvì `ki Acyw `~ixKib iyZc~iY fywgKv ivLe| Dbqbkxj `ki RbmsLv cwiKbvKvixì Rb GwU GKwU AZ AvKlbxq cwiKbv nZ cvi| Avkv Kiv hvq GB Melbv nZ cv djvdj cKvwkZ nj wkì ^vi Dci iZc~ib cfve dje| `wY Gwkqvi wkì Rb Rb^v I cyw welqK cwiKbvi Dbqb Kiv hve, hvi viv wkì ^vI DbwZZ ecK f~wgKv ivLe| Kb GB MelYvq Afy nIqvi Avnvb Rvbvbv nQ?
78
AvcbvK GB MelYvi Afy nIqvi Avnvb Rvbvbv nQ KviY Avcbvi mnhvMxZvi Rb mwVKfve gvZ`y `vb I wki cwic~iK Lv` MnYi gvag Lv`fvm Dbqb, wki ew Ges Acywi ecKZvK iva KiZ mvnvh Kie| ivMx/Di`vbKvixi wbKU nZ wK Avkv Kiv hvq? Avcwb hw` GB MelYv KvR AskMnb KiZ mZ nb Ze Avgiv AvcbvK Avcbvi Av_ mvgvwRK Aev, wki Rb eZgvb Zij I k Lvevii eev, k ev Zij Lvevi i Kivi mgq, `y`vbi Rb evZji eenvi mK wKQy ck Kie| Avgiv AviI RvbZ PvBe h cvwievwiK I cvovcwZkx v Avxq bq Ggb Kn AvcbvK beRvZKi Lv`vfvm mK Dc`k w`qQ Ges MZ 24 NUvq KZevi wkwU Lv` Mnb KiQ| Avgiv Avcbvi IRb I DPZv Ges Avcbvi wki IRb, `N, ga evi cwigvcGes 24 NUvq m h Lv` Mnb Ki Zv cwigvc Kie| GB cyiv cwqvwUi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne| Avgiv AvcbvK m^wjZ AvjvPbvZ AskMnb Kivi Rb Avgb hvbvwQ | GB AvjvPbvZ AskMnb Kivi Rb Avcbvi 1 NUv mgq Avgvì ìKvi ne| SzuwK Ges DcKvixZv:GB MelYv Kvhi mv_ hy nj Zgb Kvbv wZ nevi mvebv bB , eis GB MelYvq AZfy nj Avcwb v Avcbvi wkkyi Avcbvi eZgvb cywMZ Aev Ges G mwKZ h Kvbv Z_ RvbZ cvieb| hw` GB Melbv Kvhg Avcwb AvgvìK mvnvh Kib Ze Zv mZx_ AskMnb cvMvgwU Dchy cgvb wnme mwVKgvZ`y `vb I cwic~iK Lv`vfvm Zwii gvag Acyw `yixKib evsjv`ki ki wkì mvnvh Kie| MvcbxqZv ivq cwZkwZ:Avcbvi h Kvbv Z_ Avcwb eZxZ mKji wbKU Mvcb ivLv ne| Z_mg~n AvBwmwWwWAviwei KwDUvi msiwZ _vKe| Avcbvi wbRi mK h Kvbv Z_ RvbZ PvBj Avgiv AvcbvK Zv RvbvZ eva| fwelZ eenvii Rb Z_:hw` cv djvdj Avkvbyic nq, Ze mZx_ AskMnb cvMvgwU Dchy cgvb wnme mwVKgv`y `vb I cwic~iK Lv`vfvm Zwii gvag Acyw `yixKib evsjv`ki ki wkì mvnvh Kie| AskMnY AwbQv ev ev` `qvi AwaKvi: Avcbvi MelYv KvR AskMnY cyivcywi Avcbvi Dci wbfikxj| Avcwb PvBj AskMnb KiZ cvib A_ev weiZ _vKZ cvib| hKvb cki Di bvI w`Z cvib| PvBj hKvb mgq MelYvq AskMnY cwinvi KiZ cvib| MelYv Kvh AskMnY bv KiZ PvBjI Avcwb AvBwmwWwWAviwe KZK c` DbZ mev Ges wPwKrmv jvf Kieb| wZc~iY:-
79
Avcbvi GB MelYv Kvh AskMnb m~Y Avcbvi BQvi Dci wbfikxj| AskMnYi Rb Kvb wZc~iY `qv ne bv| hw` Avcbvi ^v mwKZ Kvb wRvmv _vK Ze Zv GLb ev fwelZ MelYv PjvKvjxb mgq KiZ cvieb|G Rb Avcwb cavb MelK W: W: G.K.BKevj Kweii mv_ hvMvhvM KiZ cvib| gnvLvjxi AvBwmwWwWAviwe , XvKv nvmcvZvj mivmwi hvMvhvM KiZ cvib ev 8860523(G. 2312) ev 017130095515 bv^vi K_v ejZ cvib| GQvovI Avcbvi AwaKvi mwKZ Kvb wRvmv _vKj Avcwb wg. Gg G mvjvg, gvbRvi, AvBAviwe mUvixqU, AviG, AvBwmwWwWAviwe, gnvLvjx, XvKv-1212, Gi mv_ hvMvhvM KiZ cvib ev Awdm bv^vi 8860523-32 (G.3206) ev+880-2-9886498 bv^vi K_v ejZ cvib| hw` G mKj kZ Avcwb/Avcbvi ivMx GB MelYv Kvh AskMnY KiZ Pvb, Ze AbyMn Ki wbPi wPwZ Ask Avcbvi `LZ ev Avyji Qvc c`vb Kib| mnhvwMZvi Rb AvcbvK abev`|
AskMnYKvixi `LZ ev Avyji Qvc AskMnYKvixi mv_ AvMZ AwffveK `LZ ev Avyji Qvc mvvrKvi MnYKvixi `LZ cavb MelKi `LZ
ZvwiL
ZvwiL
ZvwiL
ZvwiL
(Kvb Kvib cavb MelK AbycwZ _vKj Zvi cwZwbwai bvg , `LZ) { KwgwU m^^q mUvixi bvg I dvb bv^vi :Gg G mvjvg Lvb, dvb 9666498(WvBi), wcGweG 8860523-32,G3206}
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PEER COUNSELLING TO IMPROVE FEEDING PRACTICES AND REDUCE MALNUTRITION IN CHILDREN 0-2 YEARS IN BANGLADESH
QUESTIONNAIRE
Principal investigator: Dr. A.K. M. Iqbal Kabir Scientist : Clinical Sciences Division
ICDDR, B: Knowledge for Global Lifesaving Solution

GPO Box- 128, Mohakhali, Dhaka-1000, Bangladesh
QUESTIONNAIRE-1
81
PREGNANCY DATA FORM (To be filled during 8th month of pregnancy)

1. Interviewer code (1-6) ___/ 2. ID no. __/__/__/ 3. Section no. __/ 4. Block and house no. __ /__/__/__/__/ 5. Date of interview __ /__/__/__/__/
Interviewer`s name :
ASK MOTHER these questions What is your name? ______________

6. How many children do you have? __/ 7. Is this your 1st/2nd/3rd/4th/5th pregnancy? __/ 8. How many people live in this house(household members) __/__/ (eating from the same pot at present) 9. Does your husband live in this house __/ 1 = no, separated 2 = no, lives in city/abroad dead 4 = no, has another wife 5 = yes comes and goes 10a. Besides your husband, do any of the following family members live in this house, who can influence decisions about baby`s feeding (1 = no, 2 = yes ) Your mother __/ Your husband`s mother __/ Your sister-in-law __/ Others (specify) __/
3 = no, 6=
82
Does any influential family member live in this union Specify who ___________________________ 10b. __/ 11. __/__/ 12. __/__/ Religion of family
What is your age (years)
How many grades/classes have you studied
(Q 13-21for SE status ) 13. What has been your occupation during current pregnancy __/ 1 = housewife 2 = maid 4 = office employee 5 = professional 7 = others ( specify ) If housewife, go to Q.16 14. __/ 15. __/ Are you employed at present? 1 = no 2 = yes
3 = factory worker 6 = business
Have you had any antenatal checkups (ANC) during this pregnancy 1 = no 2 = yes If no, go to Q.18
16. __/ 17. __/
How many ANC have you had so far?
ANC where? 1 = FWC 3 = other clinic in union 5 = hospital (give name) 2 = satellite clinic 4 = other clinic elsewhere (name)
18. Have you had Tetanus Toxoid (TT) injections __/ 1 = no 2 = partial 3 = all complete ASK HUSBAND (as far as possible),the following questions: IF HUSBAND IS NOT AVAILABLE, ask mother to check with husband and inform 19. What is your (husband`s) occupation __/ 1 = unemployed 2 = farmer
3 = laborer (sk/unsk)
83
4 = rickshawpuller 7 = professional 20.
5 = driver 8 = business
6 = office employee 9 = other (specify)
How many grades/classes have you ( husband) studied __/__/
21. a) what is your (husband`s) monthly income (in takas) /_ /_/_/_/_/ b)income of wife (if earning) /_/_/_/_/
22. what is the total family income /_/_/_/_/
If there is previous living child, ask MOTHER the following questions, If not, go to Q.35 What is the name of your youngest baby 23. How old is s/he? (months) /_/_/ 24. /_/ Did you breastfeed (name)? 1 = no 2 = yes ________________________
25. /_/
Did you give (name) colostrums?
1 = no
2 = yes
[Explain that colostrums is the thick, yellowish secretion Produced from the breast in the first week of life]
26. How old was (name) when you started to give /_/_/ her/him plain water? (in days)
Ask for complementary feeds 84
27. /_/
Did you give him/her any additional food along with breast milk
(not prelacteals) when s/he was a small baby (before 6 months) 1 = no 2 = yes
If no go to Q.33 If yes, ask Q. 28 28 /_/ What additional food did you start first?
1 = cow`s milk = banana 6 = others (specify)
2 = powder milk
3 = gruel
4 = rice
7 = dont know/dont remember
29. How old was (name) when you started to give this food (days)? /_/_/
30. /_/
Why you did give this _______?
1 = insufficient milk 4 = for better growth restless/not sucking 7 = baby sick weak
2 = to accustom baby to other milk 5 = mother employed
3 = mother sick 6 = baby
8 = too much housework
9 = mother
31. Did anyone advise you to start these (complementary ) feeds? (1 = no Mother /_/ Mother-in-law /_/ Friend/relative /_/ 2 = yes)
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Doctor /_/ Nurse/midwife /_/ husband /_/ others(specify) /_/
32. Did you use a bottle to feed the baby at any time ? /_/ (esp within 6m)
1 = no
2 = yes
33. /_/
Are you still breastfeeding her/him?
1 = no
2 = yes
If answer is yes, go to Q.35, if no,ask Q.34
34. So what was (name)`s age when /_/_/ You stopped breastfeeding her/him (in days)? 35. /_/ Have you heard any advice about infant feeding?
(Prompt for ebf, how to breastfeed bf benefits, bf duration & start of CF) 1 = no 2 = yes
If no, go to Q,38,if yes ,ask Q.36
36. If yes, what? /_ /_/ ____________________________________________________________ _/ /
86
/_/
37.
From whom did you hear this advice? Clinic staff
(1 = no
2 = yes)
/_/ mother /_/ m-in-law /_/ FP worker /_/ Friends/neighbors/relatives /_/ Media (radio and/ TV) /_/ Printed material /_/ Others (specify ) /_/ 38i). Do you plan to breastfeed the coming baby? /_/ ii). If no, why not ? /_/ ____________________________________________________ 39. How soon after delivery do you plan to start breastfeeding? /_/ 1 = within 1 hour 2 = after few hours milk flows out 4 = on 3rd day 5 = dont know 40. /_/ Do you plan to give your baby anything else in The first 3-4 days? 41. 1 = no 2 = yes 3 = dont know 2 = yes 1 = no 2 = yes
3 = after 6=
If yes, ask what other fluids do you plan to give?
1 = no
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honey /_/ misri water/suger water /_/ mustard oil & honey /_/ Plain water /_/ Mustard oil /_/ powder milk /_/ Fresh cow`s milk /_/ Other food (specify) /_/
42. /_/
Do you plan to use any family planning method after this baby
1 = no 2 = yes 3 = dont know If no or dont know, go to Q.45 If yes, ask Q.43 43a. When do you plan to start (When baby is how old?-----days) On day of birth /_/ When periods start /_/ When husband comes back /_/ Dont know /_/ 43b. When baby is----days old _/_/_/ 44. Do you have a preferred method? (if necessary, prompt for pill, condom, inj) /_/_/ 1 = no 2 = combined pill 3 = prog only pill 4 = condom 5 = IUD 6 = inj 7 = ligation 8 = homeo 9 = kabiraj 10 = withdrawal 11 = safe period 12 = foam tablet 13 = Norplant 20 = combination of 2 or more methods (specify) 45. Some people say that breastfeeding helps to space pregnancies /_/ What do you think? 1 = disagree 2 = agree 3= dont know 4 = not sure
88
46. If disagree why? /_/ _________________________________________________________ 47. /_/ If agree why? _________________________________________________________ 48. And for how long does bf help space pregnancies (months) /_/_/ OBSERVATIONS + RELATED QUESTIONS (for SE status) 49. /_/ Type of house 1 = katcha 2 = semi pucca( brick with tin roof) 3 = pucca (brick and cement) 50. /_/ 51. /_/ Number of rooms
Electricity
1 = no
2 = yes
(Assets to be coded 1 = no 52. Bed /_/ 53. Table and chair /_/ 54. Fan present /_/ 55. Radio /_/ 56. Rickshaw /_/ 57. TV /_/ 58. Sewing machine /_/ 59. Fridge /_/ 60. VCP /_/
2 = yes
89
61. /_/ 62. /_/ pucca
Own house Type of latrine 1 = none 2 = common latrine katcha 3 = common latrine
4 = private latrine katcha 6 = common sanitary 63. /_/ Water source for washing 2 = tubewell
5 = private latrine pucca 7 = private sanitary (flush)
1 = pond/river water (private) 64. /_/ 65. /_/_/
3 = piped water (common)
4 = piped
Water source for drinking (code as above)
Mother`s weight (kg)
66. Mother`s height (cm) _/_/_/_/ 67. /_/_/ Mother`s MUAC (cm)
COMMENTS
90
QUESTIONNAIRE-2 POST DELIVERY DATA Interviewer`s name
Respondent: Mother________ or other _______

1. Interviewer code (1-6) /_/ 2. ID no. _/_/_/ 3. Section no. _/_/ 4. Block and house no. /_/_/_/_/_/ 5. Date of interview _/_/_/_/_/_/_/
6. Date of birth of baby (dt-mo-yr) /_/_/_/_/_/_/ Time of birth of baby (hours) /_/_/_/_/_/ 7. Mother`s reporting of gestation age (weeks) /_/_/ 8. Where was the baby delivered? /_/ 1 = home 2 = hospital 9. Type of delivery section 1 = vaginal
3 = clinic 2 = caesarean /_/
10. Who delivered the baby /_/
91
1 = TBA (identify by kit box/bag with an organization logo) 3 = experienced relative 4 = nurse 5 = doctor 11. Baby born /_/ 0 = still birth
2 = untrained dai 6 = others specify
1 = singleton 1 = male
2 = twins/triplets 2= /_/
12. Gender of baby female
13. Where there any problems after delivery (1 =no 2 = yes ) (write from hospital records in case of hospital delivery) /_/ 14. What problems Mother given antidepressants Baby was/is in intensive care /_/ Visible congenital anomalies such as cleft palate /_/ (babies with other cong. anomalies eg. Down`s syndrome, Cardiac problems, to be excluded when diagnosed) Other problems (specify) /_/ *For exclusion form study 15. How soon after delivery did you hold the baby (hours) /_/_/ 16. What is the fast food given to the baby /_/ 1 = colostrums oil 5 =plain water 6 =mustard oil 7 = cow`s milk 8 = powder milk 9 = others If colostrums was given, go to Q.17 17. Why was this food given (code 1 = no For sweet voice /_/ To satisfy hunger /_/ To prevent cold, cough /_/ To clean stomach, mouth of throat /_/ To stop baby`s crying /_/ 2 = yes ) 2 = honey 3 = misri/sugar/glucose water 4 = honey+mustard
/_/
92
Given traditionally /_/ Colostrum insufficient /_/ Mother sick /_/ Baby do not suckle /_/ Other reason (specify) /_/ 18. Was any other fluid/milk given in the first 3 days /_/ before colostrums /_/ 19. /_/ Sugar/misri water /_/ Honey +mustard oil /_/ Plain water /_/ Mustard oil /_/ Cow`s milk /_/ Powder milk /_/ Other food /_/ 20. /_/ Have you given your baby colostrums as yet (definition as in Questionnaire 1) ( 1 = no 2 = yes ) What other food/fluids (prelacteals)were given? ( 1 = no Honey 2 = yes ) ( 1 = no 2 = yes )
If no, go to Q.26.If yes ,ask Q.21 onwards 21. Within how many hours after delivery did the baby first suckle from the breast /_/_/ 21a. Was expressed breastmilk given? /_/ 22. /_/ Did you continue other (prelacteal) fluids/milk AFTER Giving colostrum 1 = no 2 = yes
93
23. /_/ 24. /_/
Did you start new food (postlacteal)after giving colostrums? If new food started,what was it? Honey Sugar/misri water
/_/ Honey +mustard oil /_/ Plain water /_/ Mustard oil /_/ Cow`s milk /_/ Powder milk /_/ Other food /_/ 25. Where these other feeds continued or given in addition to colostum (code 1 = no 2 = yes ) For sweet voice /_/ To satisfy hunger /_/ To prevent cold, cough /_/ To clean stomach, mouth of throat /_/ To stop baby`s crying /_/ Given traditionally /_/ Colostrum insufficient /_/ Mother sick /_/ Baby do not suckle /_/ Other reason (specify) /_/ 26. After delivery, did anyone tell you /_/ When to start breast feeding, or did you start yourself 1 = started myself 2 = dai 3 = baby`s maternal grand mother 4 = baby`s paternal grandmother 5 = nurse 6 = doctor 7 = PC
94
27. /_/ 28. /_/
Did anyone actually help you to hold your baby correctly If yes ,who helped you? Dai/TBA baby`s maternal grandmother
/_/ baby`s paternal grandmother /_/ nurse /_/ doctor /_/ PC /_/ Others /_/ 29. Since sunrise yesterday till sunrise today, What have you fed the baby (Prompt for water and other food in addition to breastmilk) TOTAL colostrums honey sugar water honey+m.oil plain water mustard oil cow`s milk powder milk other (specify) ____________ _____________ ___________ ________ ________ __________ ____________ _____________
Time Food Time Food NUMBER OF FEEDS ________ _______ _ ________ ________ ________ ________ ____ _____ _______ ________ ________ _________ _________ ________ ________ _____ ______ ________ ________ _____________ ____ _____ ________ ________ ________ ________ ________ ________ 30. /_/ 31. /_/ Did you use a bottle for feeding ? Where does the baby sleep at night 1 = same bed as mother 3 = different room 1 = no
2 = yes
2 = same room, but different bed
95
32. /_/ 33. /_/
If anyone helping with mother`s share of housework 1 = no 2 = yes
If helped, by whom? Baby`s maternal grandmother Baby`s paternal grandmother
/_/ Baby`s aunt /_/ Servant /_/ Neighbor /_/ Other (specify) /_/ 34a. baby`s weight in kg (1st reading)* /_/_/_/ b. baby`s weight in kg (2nd reading)* * (To be referred if wt <1800 g) 35. Baby`s length in cm (1st reading) /_/_/_/ 36. Mother`s weight (kg) /_/_/_/ 37. Mother`s MUAC (cm) /_/_/_/ 38. Feeding status /_/ OTHER EBSERVATIONS and COMMENTS
/_/_/_/
96
QUESTIONNAIRE 3 (
WEEKS) Interviewer name:
1a. Interviewer code 1-6 1b. Respondent Mother ___/ Maternal GM___/ Paternal GM___/Aunt___/Others___/ 2. ID no. /_/_/_/ 3. 4. Section no. Block and House no. /_/_/ /_/_/_/_/_/ /_/_/_/_/_/ /_/_/
5a. Date of interview b. Visit week no Ask mother, how are you? 8. Do you stay at home all the time OR (if employed), have you resumed paid work? 1 = at home 2 = resumed work
/_/ 3 = planning to join
PART 1
MORBIDITY
Now I am going to ask you how_____(baby`s _name) was during the last 7 days. I will start by asking about the last 24h from sunrise yesterday to sunrise today-and then about the day before-then the previous day and so on. 9.From sunrise yesterday until sunrise today, how has____been? 1 = not well 2 = well LAST 24 HRS (please fill boxes below) 9a). Did____ have symptoms or illness from sunrise yesterday until sunrise today: /_/
/_/
97
1 = no. 2 = yes, (prompt for specific illness if not mentioned spontaneously ), 3 = not known (IF YES ,also CODE 2 = YES in past week for same illness)
PAST WEEK (please fill boxes bellow) 10a). Did _____have any other illness in the past week /_/ CODE 1 =no 2 = yes 3 = dont know (IGNORING ANY WHICH HABE ALREADY BEEN MENTIONED AS PRESENT IN PAST 24 HRS)code 2 only if symptoms in the box are present
NO b c d e
SYMPTOM or ILLNESS Diarrhea Dysentery Cough fever
PAST 24 HRS
PAST WEEK
If the baby DID NOT have DIARRHOEA, DYSENTERY, COUGH OR FEVER GO TO Q.13 If the baby DID NOT have DIARRHOEA OR DYSENTERY, but HAD COUGH OR FEVER, GO TO Q.12i If the baby HAD DIARRHOEA, ORDYSENTERY, ASK Q.11 (fill appropriate boxes) 11) ASK whether any TREATMENT was given (including ORT)& COST OF EACH ONE 1 = no treatment required 2 = ORS 3 = kabiraj med (herbal) 4 = homeopathic med 5 = local healer 6 = allopathic med 7=2+6 NO NAME CODE 11a. COST (taka ) 1 2 3 b) When _____ had diarrhea /dysentery, did you go anywhere outside the home to get treatment for him/her? 1 =no 2 = yes /_/ c) If yes, how much did you spend on travel (takas)? /_/ d) How much did you spend on service/doctor/healer`s fees /_/_/_/_/_/
e) besides treatment and travel ,did you spend anything else in connection with this illness ?(special food, tips etc) If yes, specify on what,_________ And how much /_/_/_/_/_/ f) during diarrhea, did you feed breast milk ? 1 = no, 2 = same, 3 = more, 4 = less /_/
98
(For cough) If the baby DID NOT have COUGH OR FEVER , go to Q.13 12) If the baby had cough and fever ,ASK WHETHER ANY TREATMENT WAS GIVEN AND THE COST OF EACH ONE 1 = no treatment 2 = liniments applied locally 3 = kabiraji med (herbal) 4 = homeopathic med 5 = local healer 6 = allopathic med NO 1 2 3 NAME CODE 12a. COST (taka )
b) When _____ had cough and fever, did you go anywhere outside the home to get treatment for him/her? 1 = no 2 = yes c) If yes, how much did you spend on travel (takas)? /_/_/ /_/_/_/_/_/
d) How much did you spend on service/doctor/healer`s fees
e) besides treatment and travel ,did you spend anything else in connection with this illness ?(special food, tips etc) If yes, specify on what,_________ /_/_/_/_/_/ And how much For sever e illness 13. Since your last interview, has _____ had any illness for which s/he had to be taken to a health Facility/clinic/hospital or others for treatment? (1 = no, 2 = yes ) IF NO,GO TO Q.14 If yes, specify illness and give name of clinic also 1 = UTPS or other NGO clinic 2 = govt. health facility 3 = govt hospital 4 = other hospital/ICDDR,B 5 = private clinic 6 = doctor`s chamber 7 = from pharmacy 8 = homeopath 9 = kabiraj/fakir/huzur 10 = allopath+ homeopath 11 = homeo= kabiraj /_/
Visit 1 Type of health facility codes: Date (approx)-dd/mm/yy Reason Codes:
Visit 2
Visit 3
99
Medicine given (1) Cost (1) Medicine given (2) Cost (2) Medicine given (3) Cost (3) Total medicine costs Total travel costs Service fees Other expenditure If admitted, no. days Total expenditure OTHER COSTS 14a. Did you lose any wages because you stayed at home (1 = no, 2 = yes ) b. If yes, how much x. Did your husband lose any wages because baby was sick c. If yes, how much d. Were there any other costs (because baby was BF & mother had to stay at home-specify) /_/ /_/ _/_/_/ /_/ /_/_/_/_/_/ /_/_/_/_/_/
SECTION II For termination of ebf- (anything on 2 successive days) 16. Since my last visit, is there anything besides breast milk that you have fed your baby ? (prompt for water ) 1 = no 2 = yes /_/
If no, had only BM reported, ask Q.35.If yes, ask Q.17A 17a. What did you feed him/her at that time (or when you started giving something in addition to BM 1 = no 2 = yes Enter column 2 (for milk, gruel, other food, go to Q.22A) 1 = water __/ 2) sugar water __/ 3) Juice __/ 4)ORS /_/_/_/ /_/ /_/ 4 = hand After term.def 5 = dropper
17b. What baby`s age (in days) when----(name food) was first started 17c. Did you give this food/other food on the next day as well? 1 = no 2 = yes Enter column 3 If no, go to Q.30 If yes, ask Q 17D & 18 onwards 17d. What did you use for feeding this food 1 = bottle 2 = spoon 3 = both On 24 hours recall Day 1 food Day 2 food
100
EBF 18. /_/ After applying termination definition, the baby is 1 = EBF 2 = PRedom BF
19A. And why did you think baby needed this/these fluids? /_/_/ (write in mother`s words) 20. Did anyone advise you to start this fluid? a) no one __/ b) mother __/ c)mother-in-law __/ e) nurse __/ f)doctor __/ g) FP worker __/ i) PC __/ j) husband __/ k) other __/ If mother is not partial bf, go to Q 22. If no, go to Q.31
d) neigh/frnd/relative __/ h) Dai ___/
SECTION II b) (for termination of predominant bf/or feeding ___ [named fluids]) 21. Since my last visit, is there anything else besides breast milk and these fluids that you have fed your baby? (prompt) 1 = no 2 = yes /_/ If no go to Q.31.If yes, ask Q.22A 22A. What was baby`s age when comp food was first started (days) /_/_/_/ 22B. What food did you feed her/him? (enter in column t) 1) Cow`s milk __/ 2) powder milk __/ 3) gruel __/ 4) fruit __/ 5) others __/ Did you give this (name food as mentioned above) enter column 3 on the next /_/ As well 1 = no 2 = yes
22C. day
If no, go to Q.31. If yes, ask Q.22D (in box) and Q.24 onwards 22D. /_/ What did you use for feeding this food? 1 = bottle On 24 hours recall PRBF/ PTBF/ EBF Day 1 food 2 = spoon Day 2 food 3 = both 4 = hand 5 = dropper
After term.def
23. After applying termination definition, the baby is /_/ 1 = EBF 2 = PRBF 3 = PTBF For partial bf, ask following questions
4 = non-BF
101
24A. And why did you think baby needed these additional (comp) feeds in addition to /_/_/ breast milk (write in mother`s words-to be coded later reasons for individual foods not required) _____________________________________________________ B. /_/ /_/ 25. Did anyone advise you to start this fluid? a) no one __/ b) mother __/ c)mother-in-law __/ d) neigh/frnd/relative __/ e) nurse __/ f)doctor __/ g) FP worker __/ h) Dai ___/ i) PC __/ j) husband __/ k) other __/ 26A. If other milk is given, which one do you give? /_/ 1 = infant formula 2 = half cream milk 3 = full cream milk 4 = condensed milk 5 = cow`s milk 9 = comb (Recorded after tin/packet seen by interview) B. In what dilution is CM given? /_/_/ (Give times dilution, eg. 02 = 2 times, 10 = 10 times) c. /_/_/ D. times? If concentrated, how many /_/_/ In what dilution is PM given? If mother say`s insufficient BM ask why she thought so (to be coded later) /_/
Ask Q.27 only if bottle use has been specified before in Q.15y or z 27. so? /_/ 28. /_/ __________________________________ Only ask Q.29 if breastfed before but stopped now 29. /_/ 30. SPECIAL GROUP QUESTIONS How many days did you breastfeed altogether? If other food is given, what was it ? If mother uses a bottle why does she do /_/_/ __________________________________
If baby was non- bf on last visit,(or was partially bf and now is on ebf0, i.e mother has changed her feeding practice.
102
Baby maybe
Partial bf predom bf ebf
Ask following questions: a) If NON BF: when did you start breastfeeding (baby`s age or b) if PRBF or PTBF: When did you stop other feeds () /_/_/ c) How and why did you decide to change your babies feeding practice? /_/ ________________________________________________________ _/ ________________________________________________________ ________________________________________________________ (note suggestions by self/media/ health facility/individuals)
To check for PC and FP 31. Since we visited you the last time, did anyone apart from your family and friends, come and advise you about feeding your baby 1 = no one 2 = dai 3 = fp worker 4 = PC 5 = nurse doctor If above is 1,go to part iii,Q.33. If yes is code 2-6 ask Q.32 If non-bf,go to part lll Q.33 32i). Did she observe you while you were breastfeeding to check how you were doing 1 = no 2 = yes ii) Did she show/help you to hold the baby while breastfeeding ? 1 = no 2= yes /_/
/_/ 6=
103
CONTRACEPTIVE PRACTICE PART III 33a. /_/ b. /_/_/_/ Have you started having periods again? 1 = no If yes, what was baby`s age in days when it started 2 = yes
34A. Are you using any family planning method to delay your next child? /_/ 1 = no 2 = yes B. /_/_/ If answer is 1,go to Q.36 35A. If yes how are you doing it (prompt for methods)
1 = combined pill 5 = inj 6 = Norplant 7 = bf frequently 8 = homeo 10 = abstinence 11 = more then 1 method 12 = Withdrawal 9 = kabiraj 13 = ligation 2 = prog only 3 = condom 4 = IUD
Number of days abstinence practice postpartum
B. _/ C. /_/
Method started when baby was how old? (days) contraceptive method advised by? 1 = family planning worker 3 = husband 2 = health facility staff 4 = others
/_/-
104
36. /_/
Are the LAM criteria applicable for this mother? 1 = no
2 = yes
37. LAM not applicable because a. BF gap during day > 4 hours /_/ b. BF gap during night > 6 hours /_/ To check on number of actual visits 38A). Since our last visit, please tell us How many times were visited by the FP worker 0 = not visited 1 = visited once B) (for intervention group only) How many times you were visited by the PC OBSERVATIONS 39. Baby`s weight in kg Baby`s weight in kg 40. 41. 42. 43. /_/ Baby`s length in cm Baby`s length in cm Mother`s wt in kg Mother`s MUAC Feeding status 1 = EBF 2 = PRBF 3 = PTBF 4 =NON-BF
/_/
/_/ /_/_/_/ /_/_/_/ /_/_/_/ /_/_/_/ /_/_/_/ /_/_/_/
OTHER OBSERVATIONS and COMMENTS
105
Section 1: Information on Children

Interviewer`s name : 1. Interviewer code (1-6) 2. ID no. 3. Union no. 4. Block and house no. 5.Date of interview ___/ __/__/__/ __/ __ /__/__/__/__/ _ /__/__/__/__/
INTERVIEWER VISITS 1 DATE INTERVIEWERS NAME RESULT* NEXT VISIT: DATE

TIME
FINAL VISIT DAY MONTH YEAR 10 INTV. CODE RESULT* TOTAL NO. OF VISITS
**RESULT CODES: 1 COMPLETED 2 NOT AT HOME 3 POSTPONED 4 REFUSED 5 PARTLY COMPLETED 6 RESPONDENT INCAPACITATED 7 OTHER (SPECIFY)
SUPERVISOR FIELD EDITOR OFFICE EDITOR KEYED BY
NAME
NAME
106
Interviewer`s name : 1. Interviewer code (1-6) 2. ID no. 3. Union no. 4. Block and house no. 5.Date of interview
___/ __/__/__/ __/ __ /__/__/__/__/ _ /__/__/__/__/
INTERVIEWER VISITS DATE DATE
107
Section:2
Child Feeding Practices

Codes and Categories Yes.1 No..2 Immediately after birth..1 Within 24 hours.2 After 24 hours of birth...3 Yes.....1 No..2 Upsets babys stomach..1 Benefits mother ....2 Benefits baby.3 Benefits both mother and baby..4 Makes no difference..5 Others6 Dont know/not sure..7 Do nothing to increase...1 Increased intake of foods...2 Increased intake of fluid3 Others________________________4 Specify Rice..A Pulses...B Fish..C Meat.....D Eggs.....E Vegetables...F Milk.G FruitsH Others.. I Yes...1 No....2 Yes...1 No....2 Dont know..3 Yes...1 No....2 Dont know..3 Age in days Not applicable/Not yet..999 Age in days Not applicable/Not yet..999 Skip
Q# Questions and Filters 1 Did you breastfed(name)? 2 3 4 How long after birth of (name)did you begin breastfeeding him/her? Did you feed the first milk (colostrum) to this child? What happens if a mother feeds colostrum to a newborn?
What did/do you do to increase breast milk production?
21
What were those foodsthat you increased the intake for? (Anything else?)
7 8 9
Are you still breastfeeding the child? Are you still exclusively breastfeeding the child?
At any time(name) has eaten or drunk anything other than breastmilk? 10 At what age did you first give plain water, sugar water, honey water, or semi-solid or solid foods besides breast milk? 11 At what age did you first give (name) fruits, vegetables, porridge or dal?
108
12 At what age did you first give (name) rice, wheat, meat, fish or eggs? 13 At what age did you give (name) any other thing in addition to breast milk? 14 What happens if solid food is introduced to a child before 6 months? 15 What happens if solid food is introduced to a child before 6 months?
Age in days Not applicable/Not yet..999 Age in days Not applicable/Not yet..999 Bad for child1 Makes no difference....2 Others..3 Dont know/not sure....4 Bad for child1 Makes no difference....2 Others..3 Dont know/not sure....4
SECTION 3: COMPLEMENTARY FEEDING PRACTCE

109
Q# Questions and Filters 16 What other foods do you give your complementary food is given to your child?
Codes and Categories Khichuri .1 Halwa /Shuji /Fernee..2 Fruits ..3 Pitha4 Family food..5 Food from shops (Cake , Biscute, Bread etc) 6 Others (Identify) ..7 N/A88 Khichuri 1 Halwa /Shuji /Fernee 2 Fruits.... 3 Pitha.4
Skip
17
If you give family food then what kind of food do you give mostly ?
18
Familyfood..5 Food from shops (Cake , Biscute, Bread etc).6 Others (Identify)..7 N/A88 Yes Do you prepare the 1 complementary food No with oil for your child? 2 (If N/A=88 don't feed Complementary /__/__/ feeding ) How many days do you cook khichuri for last seven days? / __/__/ Days (If N/A=88 don't feed Complementary feeding) Days (If N/A=88 don't feed Complementary feeding ) Days (If N/A=88 don't feed Complementary feeding )
19
20 21
How frequent the child is feed khichuri for the days cooked? How many eggs are given to the child for last seven days ? /__/__/
22
How many fruits did you give to the baby for last seven days?
Days (If N/A=88 don't feed Complementary feeding )
110
SECTION 4: FOOD FREQUENCY QUSETIONNAIRE
(24 hour Recall Method& 7 days)

o 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 Name of the food Rice (cup) Bread/ chapati (piece) Pulse (cup) Meat / Fish (piece) Egg (piece) Milk (Cup) Khichuri (Normal) Khichuri (Formulated cup) Leafy vegetable (cup) Fruits (piece) Halua/suji/Firni (cup) Chira/ Muri (cup) Biscuit Sugar/Gur (tea spoon) Oil (tea spoon) Others (identify) Quantity Frequency 7 days
Anthropometry measurement
Q# 17. a. 17. b. 17. b. 18. a. 18. a. 19. a. Questions and Filters Lentgh in cm (1st time) Lentgh in cm (2nd time) Lentgh in cm (3rd time) Weight in Kg (1st time) Weight in Kg (1st time) MUAC(mm) Codes and Categories Skip
. . . . . .
111
Ending Time:
Hour Minutes
112

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RRC APPLICATION FORM

RESEARCH PROTOCOL NUMBER: PR-10001

Scientist, ICDDR,B, Mohakhali, Dhaka-1212, Emailikabir@icddrb.org, 8860523-32(2312)

Dr. A.K.M. Iqbal Kabir (Acting )

Check here if appendix is included

Description of the Research Project

Background of the Project including Preliminary Observations

Research Design and Methods

o i f nsa f na t t 3, 6, 9 & 1 mnh 2 ot s

o i f nsa f na t t 3, 6, 9 & 1 mnh 2 ot s

o i f nsa f na t t 1 & 1 mnh 2 8 ot s

o i f nsa f na t t 1 & 1 mnh 2 8 ot s

Source: http: //banglapedia.search.com.bd/HT/M_0260.htm

Each community-cluster (Mahalla) has an average population of 70,000 and an expected

(a). (b). (c).

Manpower Administrative infra-structure Expertise

The questions asked will be based on the

Time line for survey study

Data analysis Report writing

This study doesnt involve use of any animal.

Biography of the Investigators

Name: A.K.M. Iqbal Kabir

relevant to the present research proposal)

4.0 List of ongoing research protocols

1. Name: Michael J. Dibley

relevant to the present research proposal)

4.0 List of ongoing research protocols

Biography of the Investigators

Name: Dr. S. K. Roy Present Position: Senior Scientist Educational background:

relevant to the present research proposal)

FRCP Ph.D in Nutrition Certificate on Food, Nutrition, Biotechnology & poverty

M.Sc. in Human Nutrition MBBS

4.0 List of ongoing research protocols

Biography of the Investigators

Name: Seema MIHRSHAHI Present Position: October 2009

relevant to the present research proposal)

4.0 List of ongoing research protocols

Biography of the Investigators

Name: Kingsley Emwinyore Agho

2 Present Position: Research Fellow in Biostatistics, School of Medicine The University

Educational background: Doctor of Philosophy, University of Technology,

relevant to the present research proposal)

4.0 List of ongoing research protocols

Biography of the Investigators

Educational background: M.B.B.S 1994

4.0 List of ongoing research protocols

Has the budget been cleared by Finance Department? Yes No

If the answer is No, please explain the reasons:

_______________________________ Signature of the Principal Investigator

INFORMATION TO INCLUDE IN ABSTRACT SUMMARY

Application ID: 633229

Ethics Certificate of Dr. A.K. M. Iqbal Kabir

Ethics Certificate of Dr. S. K. Roy

Ethics Certificate of Dr. Anadil Alam

Consent Form (18-45)

_______________________________________ Signature of the PI or his/her representative

Consent Form (Bangla)

_______________________________________ Signature of the PI or his/her representative

Assent Form (Bangla)

ICDDR, B: Knowledge for Global Lifesaving Solution

PREGNANCY DATA FORM (To be filled during 8th month of pregnancy)

ASK MOTHER these questions What is your name? ______________

What is your age (years)

16. / 17. /

How many grades/classes have you ( husband) studied //

Respondent: Mother__ or other _

d) neigh/frnd/relative / h) Dai _/

_/ /// / ///// _ /////