Clinical Trial: Locally Prepared Supplement to Support Growth and Brain Health

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study on a Locally Prepared Food Supplement to Support Growth and Brain Health

Brief 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 Summary:

Up to 1050 children aged 15 months to 6.99 years, and older children if they are 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 re
Sponsor: Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: baseline and 24-30 weeks after baseline testing ]
    Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.
  • Mid-upper arm circumference [ Time Frame: baseline and 24-30 weeks after baseline testing ]
  • Cerebral blood flow [ Time Frame: baseline and 24-30 weeks after baseline testing ]
    By infrared spectroscopy
  • % 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 ]


Original Secondary Outcome: Same as current

Information By: Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging

Dates:
Date Received: December 17, 2016
Date Started: January 2017
Date Completion: August 2017
Last Updated: January 9, 2017
Last Verified: January 2017