Saving Brain in Uganda and Burkina Faso

August 1, 2013 updated by: Makerere University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Makerere University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
  • Informed caregiver consent

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: one year
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
Time Frame: 3 months
Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
School attainment
Time Frame: One year
School attainment in the intervention compared to school attainment in the control group
One year
School readiness
Time Frame: One year
The age at which children are ready to start school in the intervention compared to the control group.
One year
Physical growth
Time Frame: One year
Compare the proportion of children with poor nutritional status in the intervention and control group.
One year
Behavioural and emotional status
Time Frame: One year
Behavioral and emotional status of children in the intervention compared to those in the control group
One year
Household economic status
Time Frame: One year
Assess the social economic status in the intervention compared to the social economic status in the control group.
One year
Motor skills
Time Frame: One year
Compare motor skills of children in the intervention compared to the control group using MABC
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Collaborators

University of Bergen
Centre Muraz

Investigators

  • Principal Investigator: James K Tumwine, PhD, Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 20, 2013

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Grant # 0064-03 (Other Identifier: GRAND CHALLENGES CANADA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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