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Saving Brain in Uganda and Burkina Faso

Primary Purpose

Poor Performance Status, Neurologic Deficits, Mixed Behavior and Emotional Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Peer support for exclusive breastfeeding
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Poor Performance Status focused on measuring Human capital formation

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

  • Makerere University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral

Control

Arm Description

Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months

No peer support for exclusive breastfeeding

Outcomes

Primary Outcome Measures

Cognitive function
Proportion of children with impaired cognitive function in intervention compared to the control group

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2013
Last Updated
August 1, 2013
Sponsor
Makerere University
Collaborators
Centre Muraz, University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT01882335
Brief Title
Saving Brain in Uganda and Burkina Faso
Official Title
Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
Collaborators
Centre Muraz, University of Bergen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Performance Status, Neurologic Deficits, Mixed Behavior and Emotional Disorder, Malnutrition, Infections, Hospital
Keywords
Human capital formation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months
Arm Title
Control
Arm Type
No Intervention
Arm Description
No peer support for exclusive breastfeeding
Intervention Type
Behavioral
Intervention Name(s)
Peer support for exclusive breastfeeding
Other Intervention Name(s)
Peer support
Intervention Description
Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters. They were followed up for 6 months post delivery.
Primary Outcome Measure Information:
Title
Cognitive function
Description
Proportion of children with impaired cognitive function in intervention compared to the control group
Time Frame
one year
Secondary Outcome Measure Information:
Title
Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
Description
Determine the cost of promoting peer counselling for exclusive breastfeeding in relation to the cost of attending to children with poor outcomes
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
School attainment
Description
School attainment in the intervention compared to school attainment in the control group
Time Frame
One year
Title
School readiness
Description
The age at which children are ready to start school in the intervention compared to the control group.
Time Frame
One year
Title
Physical growth
Description
Compare the proportion of children with poor nutritional status in the intervention and control group.
Time Frame
One year
Title
Behavioural and emotional status
Description
Behavioral and emotional status of children in the intervention compared to those in the control group
Time Frame
One year
Title
Household economic status
Description
Assess the social economic status in the intervention compared to the social economic status in the control group.
Time Frame
One year
Title
Motor skills
Description
Compare motor skills of children in the intervention compared to the control group using MABC
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF). Informed caregiver consent Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K Tumwine, PhD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makerere University
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
33110445
Citation
Engebretsen IMS, Nalugya JS, Skylstad V, Ndeezi G, Akol A, Babirye JN, Nankabirwa V, Tumwine JK. "I feel good when I drink"-detecting childhood-onset alcohol abuse and dependence in a Ugandan community trial cohort. Child Adolesc Psychiatry Ment Health. 2020 Oct 24;14:42. doi: 10.1186/s13034-020-00349-z. eCollection 2020.
Results Reference
derived
PubMed Identifier
29474479
Citation
Tumwine JK, Nankabirwa V, Diallo HA, Engebretsen IMS, Ndeezi G, Bangirana P, Sanou AS, Kashala-Abotnes E, Boivin M, Giordani B, Elgen IB, Holding P, Kakooza-Mwesige A, Skylstad V, Nalugya J, Tylleskar T, Meda N. Exclusive breastfeeding promotion and neuropsychological outcomes in 5-8 year old children from Uganda and Burkina Faso: Results from the PROMISE EBF cluster randomized trial. PLoS One. 2018 Feb 23;13(2):e0191001. doi: 10.1371/journal.pone.0191001. eCollection 2018.
Results Reference
derived

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Saving Brain in Uganda and Burkina Faso

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