Breastfeeding Clinical Trial
Official title:
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
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.
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:
1. 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).
2. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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