Locally Prepared Supplement to Support Growth and Brain Health
Condition: Malnutrition, Child; Cognitive Function
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Locally-prepared bar; USAID Corn Soy Blend Plus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 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.
Other intervention name(s): Locally-purchased rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention