Locally Prepared Supplement to Support Growth and Brain Health

NCT03017209 | Completed

• 1 other identifier: 12356
• Study Type: interventional
• Target: 1,059
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Child; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years

  baseline and 24-30 weeks after baseline testing

Secondary Outcomes (8)

• Hemoglobin

  baseline and 24-30 weeks after baseline testing

• Changes in z-scores for weight (WAZ)

  baseline and 24-30 weeks after baseline testing

• Changes in z-scores for height (HAZ)

  baseline and 24-30 weeks after baseline testing

• Cognitive tests for children >3 years old

  baseline and 24-30 weeks after baseline testing

• Mid-upper arm circumference

  baseline and 24-30 weeks after baseline testing

Other Outcomes (6)

• Carotenoids

  baseline and 24-30 weeks after baseline testing

• Grip strength

  baseline and 24-30 weeks after baseline testing

• Weight of female-caregivers and fathers

  baseline and 24-30 weeks after baseline testing

Study Arms (3)

Locally-prepared bar

EXPERIMENTAL

The bar is similar to one tested recently in a pilot study and is a locally prepared bar designed to facilitate growth and cognitive development. It will provide 300 kcal/day and will have ≈20-30% of energy from protein (of which 25-50% is from an animal protein source), 20-35% from total carbohydrate and ≈40-60% from fat. The bar will be fortified with vitamins and minerals to meet USAID recommendations for moderate malnutrition and Dietary Reference Intake recommendations for at-risk and healthy children of the ages studied, and at the same time will not exceed Upper Level nutrient recommendations for any micronutrient. Ingredients in the bar will be a combination of local products and imported shelf-stable ingredients.

Dietary Supplement: Locally-prepared bar

USAID Corn Soy Blend Plus

ACTIVE COMPARATOR

The usual-intervention condition will be 300 kcal/day of USAID Corn Soy Blend Plus cooked in the usual manner with fortified vegetable oil (10:3 ratio) and sugar. The community health workers or other designated villagers will prepare the supplement freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.

Dietary Supplement: USAID Corn Soy Blend Plus

Locally-purchased rice

PLACEBO COMPARATOR

The placebo condition will be 300 kcal/day of locally-purchased rice cooked with a small amount of oil (10:2 ratio), which mimics the usual breakfast of children in this region. The community health workers or other designated villagers will prepare the rice freshly each intervention day using locally accepted standards for hygiene, and a quality control process for ratios of ingredients assigned by the research team to ensure consistent composition.

Other: Placebo

Interventions

Locally-prepared bar DIETARY_SUPPLEMENT

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.

Locally-prepared bar

USAID Corn Soy Blend Plus DIETARY_SUPPLEMENT

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.

USAID Corn Soy Blend Plus

Placebo OTHER

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.

Also known as: Locally-purchased rice

Locally-purchased rice

Eligibility Criteria

• Age: 15 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent or legal guardian provides consent for all children \<7 years and the parent plus the child provide consent for any child \> 7 years.
• Age 15 months to 6.99 years old or any age enrolled in first grade in the same village.
• The family plans to remain in the village for the duration of the study (up to 30 weeks) based on self-report by a parent;
• The child does not have any known food allergies as reported by the mother or guardian.

Sponsors & Collaborators

• Tufts University: lead
• Massachusetts General Hospital: collaborator
• Global Food & Nutrition Inc.: collaborator

Study Sites (1)

International Partnership for Health Development

Bissau, 1000, Guinea-Bissau

Location

Related Publications (2)

• Roberts SB, Franceschini MA, Silver RE, Taylor SF, de Sa AB, Co R, Sonco A, Krauss A, Taetzsch A, Webb P, Das SK, Chen CY, Rogers BL, Saltzman E, Lin PY, Schlossman N, Pruzensky W, Bale C, Chui KKH, Muentener P. Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial. BMJ. 2020 Jul 22;370:m2397. doi: 10.1136/bmj.m2397.

  PMID: 32699176 DERIVED

• Roberts SB, Franceschini MA, Krauss A, Lin PY, de Sa AB, Co R, Taylor S, Brown C, Chen O, Johnson EJ, Pruzensky W, Schlossman N, Bale C, Wu KT, Hagan K, Saltzman E, Muentener P. A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood. Curr Dev Nutr. 2017 Nov;1(11):e000885. doi: 10.3945/cdn.117.000885. Epub 2017 Oct 12.

  PMID: 29658962 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Susan B Roberts, PHD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 1, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)