Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health

NCT03319589 | Completed

• 1 other identifier: 1200
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Change in executive cognitive function

  Two measures of executive function, working memory and task-switching abilities, will be administered through play-based games by local research team members. "Spin the Pots" and "Reverse Categorization" tasks, modeled after Carlson et al., have been age modified and culturally adopted.

  Baseline and end line (12 weeks difference)

Secondary Outcomes (18)

• Supplementation Attendance

  Through study completion (12 weeks)

• Sicknesses

  Through study completion (12 weeks)

• Change in hand grip strength

  Baseline and end line (12 weeks difference)

• Change in Hemoglobin

  Baseline and end line (12 weeks difference)

• Change in skin carotenoids

  Baseline and end line (12 weeks difference)

Study Arms (2)

Supplement Arm

EXPERIMENTAL

School children (age 6 to 6.5) will receive their supplement 5 days a week in the morning before school starts. They will either receive the supplement at school or at the community health center depending on the preference of the villagers after recruitment. Young children (age 24 to 30 months) will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers.

Dietary Supplement: Supplement

Control Arm

NO INTERVENTION

Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics

Interventions

Supplement DIETARY_SUPPLEMENT

locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development

Supplement Arm

Eligibility Criteria

• Age: 24 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Non-malnourished children within the 2 villages chosen for study
• Within the specified age range: 24-36 months for young children and 6-7 years for older children, who will also be enrolled in their local school. In the event that researchers cannot enroll at least 15 participants in each age range in each village, will extend the age range up to 35.99 months for young children and up to 6.99 years for older children.
• The family plans to remain in the village for the duration of the study;
• The child does not have any known food allergies as reported by the mother or guardian.

You may not qualify if:

• If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape or a weight-for-age or height-for-age z-score of less than or equal to -3.0, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic

Sponsors & Collaborators

• Tufts University: lead
• International Partners for Human Development: collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: October 24, 2017
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)