Clinical trial NCT01882335: Saving Brain in Uganda and Burkina Faso
Official title: Saving Brains In Uganda And Burkina Faso (PROMISE Saving Brains)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poor Performance Status
Neurologic Deficits
Mixed Behavior and Emotional Disorder
Malnutrition
Infections, Hospital
Keywords: Human capital formation
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Centre Muraz
name: University of Bergen
First posted: 2013-06-20
Enrollment: 600
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Cognitive function
timeFrame: one year
Secondary outcomes:
measure: Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation
timeFrame: 3 months
Other outcomes:
measure: School attainment
timeFrame: One year
measure: School readiness
timeFrame: One year
measure: Physical growth
timeFrame: One year
measure: Behavioural and emotional status
timeFrame: One year
measure: Household economic status
timeFrame: One year
measure: Motor skills
timeFrame: One year
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: Makerere University
name: James K Tumwine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.