Power of Peanuts School Feeding

Integrating the Power of Peanuts Into School Feeding Programs in Ghana

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.

Study Overview

• Status: Completed
• Conditions: School Feeding Programs; Nutrition Supplements
• Intervention / Treatment: Dietary supplement: Standard meal; Dietary supplement: School food ready-to-use; Dietary supplement: School food ready-to-use plus Milk

• Study Type: Interventional
• Enrollment (Actual): 880
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Tamale, Ghana
    • Project Peanut Butter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy school children

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard meal; local porridge with a vitamin and mineral sprinkle powder that will be mixed in	Dietary supplement: Standard meal; local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking
Experimental: School food ready-to-use; peanut-based school food ready-to-use	Dietary supplement: School food ready-to-use; 80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals
Experimental: School food ready-to-use plus Milk; peanut-based school food ready-to-use with milk	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid cognition as measured by tests in NIH toolbox	Dimensional change card Sort, performance score	10 months
Fluid cognition as measured by tests in NIH toolbox	Flanker inhibitory control and attention, performance score	10 months
Fluid cognition as measured by tests in NIH toolbox	List sorting working memory, performance score	10 months
Fluid cognition as measured by tests in NIH toolbox	Pattern comparison processing speed, performance score	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height-for-age Z	difference between enrollment and end of study height-for-age z score	10 months
Change in body mass index	difference between enrollment and end of study body mass index	10 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Ghana; Project Peanut Butter, Ghana

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202011110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No