Power of Peanuts School Feeding

Not Applicable

Completed

• Conditions: School Feeding Programs; Nutrition Supplements
• Interventions: Dietary Supplement: Standard meal; Dietary Supplement: School food ready-to-use plus Milk; Dietary Supplement: School food ready-to-use

• Registration Number: NCT04349007
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This will be a two-phase protocol. Phase 1 will include the development of the peanut-based school food, and a small formative research study on the acceptability and consumption of the school food study intervention. This will occur among children 5-12 yr in the Mion district, 60 school aged children between 6-12 years old will be recruited to participate in a 3 week consumption and acceptability study. An integral part of the food development process is acceptability testing. A child must like and want to eat a new food if it is to be consumed as prescribed and effective in potential improving linear growth and cognitive performance. This study will confirm that food developed for the school feeding clinical trial will be consumed as dosed and what additional snack food offerings may be useful in encouraging consumption.

Phase 2 will be a individually randomized, investigator blinded, controlled clinical effectiveness trial of a peanut-based school meal with and without milk powder compared to a control meal for linear growth and cognitive performance. 880 children 5 to 12 years old, healthy, enrolled in primary school, including kindergarten at 6 selected schools in the Mion district will be randomized to receive one of three school foods, a peanut-based food with milk, a peanut-based food without milk and a control group composed of commonly available tuber/cereal. The sample size accounts for up to 15% attrition for a final sample size of 750 with a total 250 eligible children enrolled in each group. Enrolled children will receive the meal daily during the school lunch period for an entire school year. At enrollment and upon completion, anthropometric measurements and body composition data will be collected and a tablet- based, language independent cognitive test battery will be administered. Basic demographic information and school attendance information will be collected as well.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Study Start: 2021-09-10
• Primary Completion: 2022-08-05
• Study Completion: 2022-08-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

• Healthy school children

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Exclusion Criteria

• severe malnutrition
• chronic debilitation disease
• peanut or milk allergy
• not attending school

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard meal	Standard meal	local porridge with a vitamin and mineral sprinkle powder that will be mixed in
School food ready-to-use plus Milk	School food ready-to-use plus Milk	peanut-based school food ready-to-use with milk
School food ready-to-use	School food ready-to-use	peanut-based school food ready-to-use

Primary Outcome Measures

Name	Time	Method
Fluid cognition as measured by tests in NIH toolbox	10 months	Pattern comparison processing speed, performance score

Secondary Outcome Measures

Name	Time	Method
Height-for-age Z	10 months	difference between enrollment and end of study height-for-age z score
Change in body mass index	10 months	difference between enrollment and end of study body mass index

Trial Locations

Locations (1)

Project Peanut Butter; 🇬🇭 Tamale, Ghana