NCT04349007

Power of Peanuts School Feeding

Completed NA Last updated 23 December 2022

What this trial tests

NA trial testing Standard meal in School Feeding Programs in 880 participants. Completed in 5 August 2022.

Timeline

10 September 2021

Primary endpoint
5 August 2022

5 August 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	880
Start date	10 September 2021
Primary completion	5 August 2022
Estimated completion	5 August 2022
Sites	1 location across Ghana

Drugs / interventions tested

• Standard meal
• School food ready-to-use
• School food ready-to-use plus Milk

Conditions studied

• School Feeding Programs — all drugs for School Feeding Programs →
• Nutrition Supplements — all drugs for Nutrition Supplements →

Sponsor

Washington University School of Medicine

Who can join

Adults 5 to 12, any sex, with School Feeding Programs or Nutrition Supplements. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Peanut Paste-based Ready-to-use School Meals With and Without Milk on Fluid Cognition in Northern Ghana: A Randomized Controlled Trial.
   Stephenson KB, Wegner DR, Hershey TG, Doty T, et al · · 2023 · cited 3× · PMID 37567391 · DOI 10.1016/j.ajcnut.2023.08.001