Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Abstract
This study is a randomized controlled pilot for a future larger trial. The goals of this pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural communities, and b) to generate pilot data for sample size estimates needed for a larger trial. The study will test the effect of a supplement prepared locally with local and imported ingredients on changes in standard anthropometric benchmarks of growth, cognition, immune function, hemoglobin and skin carotenoids in young children living in 2 villages in rural Guinea-Bissau. Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics. As part of the study, we will assess the feasibility of having local commercial bakers prepare the supplement.
Conditions: Malnutrition.
Primary outcome: Change in executive cognitive function.
Enrollment: 80 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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