Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03017209
Study type Interventional
Source Tufts University
Contact
Status Completed
Phase N/A
Start date January 2017
Completion date January 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03708692 - Menstrual Cycle Phases on Recovery and Cognitive Function
Completed NCT02915913 - Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults N/A
Completed NCT01410097 - Physical and Cognitive Function - Look AHEAD Ancillary Study N/A
Recruiting NCT03208569 - Anticholinergic Burden - Treatment Optimization
Enrolling by invitation NCT03698123 - Performance Nutrition for Residents and Fellows N/A
Enrolling by invitation NCT03716609 - Effects of Magnesium Supplementation on Hemodynamic Parameters and Cognitive Function N/A
Active, not recruiting NCT02763514 - The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood N/A
Completed NCT02675621 - Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults N/A
Completed NCT02344056 - Cognition Intervention Study Dortmund- Continued (Coco) N/A
Completed NCT02277002 - Commuter Air Pollution Intervention Study N/A
Completed NCT01965795 - Whole Coffee Fruit Concentrate Pilot Study 1 N/A
Completed NCT02012881 - LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention N/A
Recruiting NCT03525561 - Acetazolamide and Exercise Performance at Altitude Early Phase 1
Recruiting NCT03500601 - Effects of Consumption of Nut Components on Cognitive Function, Intestinal Microbial Communities and Markers of Health N/A
Completed NCT01734200 - Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function Phase 2/Phase 3
Active, not recruiting NCT03526406 - Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans N/A
Recruiting NCT03168360 - Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient N/A
Not yet recruiting NCT03459183 - Effects of Infra- and Ultrasound on the Brain N/A
Recruiting NCT01734213 - Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function Phase 2/Phase 3
Completed NCT00688155 - Seniors Health and Activity Research Program-Pilot N/A