This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome will be cognitive tests of executive function. Secondary outcomes will be changes in standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living in villages in rural Guinea-Bissau. This is a within-village randomization at the level of the family, and all children will receive a dietary intervention.
Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be recruited for this study along with their maternal caregiver and father. Child ages will be based on the official birth records which families possess. The mothers/primary caregivers and fathers of the children will also be recruited for simple outcome assessments. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments. Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3 supplements and if any family (defined based on the father of the children since this is a polygamous community) has more than one enrolling child all those children will be randomized to the same supplement arm. * One supplement will be the locally-prepared bar * One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus, prepared as recommended in a 10:3 ratio with fortified vegetable oil. * One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is the typical local breakfast. Villagers will be informed of the randomization after baseline testing is complete. Following baseline measurements in children of anthropometry and body composition, grip strength, cognition, hemoglobin, and skin carotenoids, children will receive their intervention for 24-30 weeks and the same measurements taken at baseline will be repeated during the last study week. The flexible end data is given to accommodate the local rainy season and its impact on transportation. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial. Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined as children consuming ≥75% of their supplement. However, a clerical error in this clinical trial registration did not describe this predetermined focus on a per-protocol population. The registration implies an intention-to-treat (ITT) analysis by default. Investigators therefore revised our analytical approach to designate the ITT cohort as the primary cohort of interest. The secondary cohort of interest is the predefined per-protocol cohort (children consuming ≥75% of their supplement).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,059
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
International Partnership for Health Development
Bissau, Guinea-Bissau
Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years
Time frame: baseline and 24-30 weeks after baseline testing
Hemoglobin
Time frame: baseline and 24-30 weeks after baseline testing
Changes in z-scores for weight (WAZ)
Time frame: baseline and 24-30 weeks after baseline testing
Changes in z-scores for height (HAZ)
Time frame: baseline and 24-30 weeks after baseline testing
Cognitive tests for children >3 years old
Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.
Time frame: baseline and 24-30 weeks after baseline testing
Mid-upper arm circumference
Time frame: baseline and 24-30 weeks after baseline testing
Cerebral blood flow
By infrared spectroscopy
Time frame: baseline and 24-30 weeks after baseline testing
% Lean tissue and lean growth
Time frame: baseline and 24-30 weeks after baseline testing
Changes in weight for height Z scores
Time frame: baseline and 24-30 weeks after baseline testing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.