Power of Peanuts School Feeding

NCT ID: NCT04349007

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-08-05

Brief Summary

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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

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Conditions

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School Feeding Programs Nutrition Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators
Single (Investigator)

Study Groups

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Standard meal

local porridge with a vitamin and mineral sprinkle powder that will be mixed in

Group Type ACTIVE_COMPARATOR

Standard meal

Intervention Type DIETARY_SUPPLEMENT

local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking

School food ready-to-use

peanut-based school food ready-to-use

Group Type EXPERIMENTAL

School food ready-to-use

Intervention Type DIETARY_SUPPLEMENT

80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals

School food ready-to-use plus Milk

peanut-based school food ready-to-use with milk

Group Type EXPERIMENTAL

School food ready-to-use plus Milk

Intervention Type DIETARY_SUPPLEMENT

80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals

Interventions

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Standard meal

local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking

Intervention Type DIETARY_SUPPLEMENT

School food ready-to-use

80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals

Intervention Type DIETARY_SUPPLEMENT

School food ready-to-use plus Milk

80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy school children

Exclusion Criteria

* severe malnutrition
* chronic debilitation disease
* peanut or milk allergy
* not attending school
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ghana

OTHER

Sponsor Role collaborator

Project Peanut Butter, Ghana

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Project Peanut Butter

Tamale, , Ghana

Site Status

Countries

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Ghana

References

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Stephenson KB, Wegner DR, Hershey TG, Doty T, Davis E, Steiner-Asiedu M, Saalia FK, Shani I, Manary MJ. Effect of Peanut Paste-based Ready-to-use School Meals With and Without Milk on Fluid Cognition in Northern Ghana: A Randomized Controlled Trial. Am J Clin Nutr. 2023 Oct;118(4):782-791. doi: 10.1016/j.ajcnut.2023.08.001. Epub 2023 Aug 9.

Reference Type DERIVED
PMID: 37567391 (View on PubMed)

Other Identifiers

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202011110

Identifier Type: -

Identifier Source: org_study_id