Saving Brain in Uganda and Burkina Faso

Study Overview
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Brief Summary
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The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

Detailed Description
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Between 2006 and 2008 we carried out a cluster randomized study (PROMISE-EBF) to establish the effect of individual home based peer counselling on exclusive breast feeding (EBF). The results, published in the Lancet in 2011 were remarkable(Tylleskar T, et al). The PROMISE-EBF trial which compared mothers in the intervention arm that were offered at least 5 peer-visits promoting EBF to mothers in the control arm, that received the standard of care showed a doubling in the prevalence of EBF in the intervention arm. Community-based peer counsellors increased the EBF rate in Uganda and Burkina Faso from about 40% to 80%. The current study will trace and re-enrol at least 70% of the children involved in the PROMISE-EBF study. These children are now aged between 5 and 7 years. The primary objective of the current study is to evaluate the effect of peer-counselling for EBF in the first six months of life on human capital formation among children in Uganda and Burkina Faso. This study will contribute to a crucial wider discussion on external validity regarding the relationship between EBF and intellectual performance and mental health. In the social area, this study will identify solutions to potential barriers that limit scale up for peer-counselling for EBF. From the business perspective, the study will identify the best business model for affordable, acceptable and cost effective ways of delivering peer counselling for EBF in Burkina Faso and Uganda. If this intervention is found effective, and is adopted, it could improve productivity in adulthood and work towards breaking the cycle of poverty.

Official Title
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Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)

Conditions
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Poor Performance Status, Neurologic Deficits, Mixed Behavior and Emotional Disorder, Malnutrition, Infections, Hospital

Intervention / Treatment
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* Behavioral: Peer support for exclusive breastfeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF). Informed caregiver consent Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral<br>Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months | Behavioral: Peer support for exclusive breastfeeding<br>* Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters. They were followed up for 6 months post delivery.<br>* Other names: Peer support;|
| No Intervention: Control<br>No peer support for exclusive breastfeeding | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Proportion of children with impaired cognitive function in intervention compared to the control group | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation | Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human capital formation