Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Up to 20 children aged 24-30 months and 20 school children aged 6-6.5 years living in each of
      2 villages in the Oio region of Guinea-Bissau (total study population up to 80, with no
      minimum recruitment number) will be recruited for this study, with ages documented by the
      official birth record, which all families possess. 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. The villages will be broadly comparable in terms of size,
      affluence, rates of malnutrition, the presence or absence of a school meal program, and
      tribal affiliation and religion.

      One village will be randomly assigned to receive the locally-prepared biscuit and a daily
      multivitamin and the other will be randomly assigned to be an assessment-only control site.
      Because this is a pilot study designed to develop methodology for a future powered trial, and
      the logistics of local supplement preparation need to be developed in advance of the study,
      the randomization will occur prior to baseline testing to allow for development of
      infrastructure for supplement preparation. However the villagers will not be informed of the
      randomization until after baseline testing is complete.

      Following baseline measurements of anthropometry, grip strength, cognition, non-invasive
      measurements of hemoglobin, and skin carotenoids, participants will receive their
      intervention for 12 weeks and the same measurements taken at baseline will be repeated during
      the last study week. Since access for the final assessment to villages may be hampered by the
      rainy season we also request permission to terminate the trial between 9-12 weeks of
      supplement consumption depending on weather conditions. 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.
    

Intervention name(s): Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment