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Saving Brain in Uganda and Burkina Faso

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ClinicalTrials.gov Identifier: NCT01882335
Recruitment Status : Unknown
Verified April 2013 by Makerere University.
Recruitment status was:  Enrolling by invitation
First Posted : June 20, 2013
Last Update Posted : August 2, 2013
Sponsor:
Collaborators:
Centre Muraz
University of Bergen
Information provided by (Responsible Party):
Makerere University

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.

Condition or disease Intervention/treatment Phase
Poor Performance Status Neurologic Deficits Mixed Behavior and Emotional Disorder Malnutrition Infections, Hospital Behavioral: Peer support for exclusive breastfeeding Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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 Name: Peer support

No Intervention: Control
No peer support for exclusive breastfeeding



Primary Outcome Measures :
  1. Cognitive function [ Time Frame: one year ]
    Proportion of children with impaired cognitive function in intervention compared to the control group


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. School attainment [ Time Frame: One year ]
    School attainment in the intervention compared to school attainment in the control group

  2. School readiness [ Time Frame: One year ]
    The age at which children are ready to start school in the intervention compared to the control group.

  3. Physical growth [ Time Frame: One year ]
    Compare the proportion of children with poor nutritional status in the intervention and control group.

  4. Behavioural and emotional status [ Time Frame: One year ]
    Behavioral and emotional status of children in the intervention compared to those in the control group

  5. 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.

  6. Motor skills [ Time Frame: One year ]
    Compare motor skills of children in the intervention compared to the control group using MABC



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882335


Locations
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Uganda
Makerere University
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Centre Muraz
University of Bergen
Investigators
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Principal Investigator: James K Tumwine, PhD Makerere University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT01882335    
Other Study ID Numbers: Grant # 0064-03
Grant # 0064-03 ( Other Identifier: GRAND CHALLENGES CANADA )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: April 2013
Keywords provided by Makerere University:
Human capital formation
Additional relevant MeSH terms:
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Cross Infection
Neurologic Manifestations
Malnutrition
Nutrition Disorders
Nervous System Diseases
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes