Saving Brain in Uganda and Burkina Faso

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01882335
• Other study ID #: Grant # 0064-03
• Secondary ID: Grant # 0064-03
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 18, 2013
• Last updated: August 1, 2013
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2013
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyBurkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

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

• Informed caregiver consent

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Centre Muraz, University of Bergen

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	School attainment	School attainment in the intervention compared to school attainment in the control group	One year	No
Other	School readiness	The age at which children are ready to start school in the intervention compared to the control group.	One year	No
Other	Physical growth	Compare the proportion of children with poor nutritional status in the intervention and control group.	One year	No
Other	Behavioural and emotional status	Behavioral and emotional status of children in the intervention compared to those in the control group	One year	No
Other	Household economic status	Assess the social economic status in the intervention compared to the social economic status in the control group.	One year	No
Other	Motor skills	Compare motor skills of children in the intervention compared to the control group using MABC	One year	No
Primary	Cognitive function	Proportion of children with impaired cognitive function in intervention compared to the control group	one year	No
Secondary	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	No