Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh

Study Overview
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Brief Summary
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This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.

Detailed Description
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The design uses a repeated cross-sectional design, with multiple age-group samples for multiple outcomes [since each set of outcomes can only be assessed in the relevant age group for the outcome; e.g., exclusive breastfeeding is only assessed in children 0-6 months of age]. These include: For the evaluation of behavior change intervention only: 0-6 months for breastfeeding outcomes 6-23.9 months for complementary feeding outcomes (in the behavior change intervention evaluation) 24-48 months for child anthropometric outcomes (related to the behavior change interventions). for the substudy on behavior change and micronutrient powder interventions combined - 6-23.9 months for anemia and anthropometric outcomes A community-based random sample of children 0-6 months, 6-23.9 months, 24-48 months old was surveyed at baseline (April-June 2010). The original anemia sub-study design had proposed surveying children 6.23.9 months of age for the MNP intervention in April-June 2013 and for the behavior change intervention in April-June 2014. Based on program implementation timelines, the endline survey dates were extended by one year such that the above age groups were then sampled and surveyed in community-based surveys in April-June 2014. Infant feeding practices will be assessed using before-after intervention-comparison area group differences between 2010, and 2013 and 2014. Specifically, breast feeding will be assessed in children 0-6 months of age (sampled separately) and complementary feeding will be assessed in children 6-23.9 months of age (sampled separately). Stunting will be assessed in the sample of children 24-48 months of age using before-after intervention-comparison group differences between 2010 and 2014. In addition, the investigators will evaluate the processes through which the programs roll out using a mix of qualitative and quantitative research methods. Qualitative research methods will help to understand drivers of promotion and sales of MNPs by frontline health workers, as well as household level determinants and dynamics related to enabling purchase and use of the MNP and adhering to behavioral recommendations. Quantitative surveys of frontline health workers will help document their awareness about IYCF, MNPs, training, and sales, while quantitative surveys of the households will help document household level awareness, purchase and use of MNPs and awareness and adherence to IYCF practices for children in the target age range.

Official Title
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1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh

Conditions
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Child Malnutrition, Breastfeeding, Complementary Feeding, Childhood Anemia

Intervention / Treatment
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* Behavioral: EHC + BCC
* Dietary Supplement: Micronutrient powders
* Behavioral: Mass media


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child age < 60 months

Ages Eligible for Study
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Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Essential Health Care (EHC) only<br>This arm is the basic comparison arm, which will receive the standard package of health services offered through BRAC's essential health care (basic antenatal care, basic counseling on health and nutrition through health worker home visits. In addition, a nationwide mass media campaign on IYCF practices will ensure exposure to some messages about IYCF behaviors in this arm. | Behavioral: Mass media<br>* A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.<br>|
| Experimental: EHC + Micronutrient Powders<br>This arm will be based on the EHC platform but will also include EHC platform health workers promoting and selling the micronutrient powders. | Dietary Supplement: Micronutrient powders<br>* In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name Pushtikona in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others.<br>Behavioral: Mass media<br>* A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.<br>|
| Experimental: EHC + BCC<br>This arm will have a behavior chance communications intervention to improve infant and young child feeding practices. The intervention will be delivered primarily by the frontline health workers who will visit mothers in their homes and counsel them on essential IYCF practices. | Behavioral: EHC + BCC<br>* This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices<br>Behavioral: Mass media<br>* A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.<br>|
| Experimental: EHC + BCC + Micronutrient powders<br>This arm will contain both the behavior change communication and the micronutrient powder sales intervention. | Behavioral: EHC + BCC<br>* This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices<br>Dietary Supplement: Micronutrient powders<br>* In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name Pushtikona in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others.<br>Behavioral: Mass media<br>* A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding (EBF) among children 0-6 months of age | EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures | 4 years after baseline | 
| Child anthropometry (height, weight) among children 24-48 months of age | Child height and weight will be measured among the repeated cross-sectional of children living in the study villages. These will be converted into z-scores based on the WHO growth reference standards. | 4 years after baseline | 
| Complementary feeding among children 6-23.9 months of age | Complementary feeding indicators that include timely introduction of complementary feeding (infants 6-8 months), dietary diversity, minimum dietary diversity, minimum dietary diversity, are among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures in this age group. | 4 years after baseline | 
| Anemia among children 6-23.9 months | Anemia will be measured using Hemocue | 4 years after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron deficiency | Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Breastfeeding, Complementary feeding, Stunting, Wasting, Underweight, Micronutrient powder, Behavior change counseling, Frontline health worker