Peanut-based School Meals in Rural Ghana to Improve Attendance and Retention (PEANUT-SMART)

The goal of this clinical trial is to test daily provision of peanut paste-based milk-containing ready-to-use school food (PM-RUF) in children 5-17 years of age in Ghana . The main question it aims to answer is:

- Will provision of PM-RUF as a daily school meal improve attendance, improve matriculation, and/or reduce dropouts among Ghanaian schoolchildren 5-17 years of age in Mion District as compared with provision of a common local flour made of rice/millet?

Study Overview

• Status: Recruiting
• Conditions: School Feeding Programs; Child Nutrition; School Attendance; School Dropouts; School Enrollment
• Intervention / Treatment: Dietary supplement: Ready-to-use school food; Dietary supplement: Standard meal

Detailed Description

School feeding programs offer an opportunity to advance individual and community health and well-being, especially in contexts of poverty and limited diet quality. When compared with no school feeding, school feeding has been shown to improve attendance, reduce dropouts, and strengthen household food security.

In many low- and middle-income countries (LMICs), a model called Home-Grown School Feeding (HGSF) has been employed in an effort to increase the coverage of school feeding programs. This model involves local growing, procurement, and cooking of school meals, thereby aiming to boost local economies and improve sustainability. A potential drawback of this approach is the nutritive quality of the school meals, which will depend on what is typically grown and procured in the program. In areas of higher food insecurity, such a program may largely provide the foods to which children already have access, rather than nutrients their diets may be missing. Additional concerns include costs related to decentralized procurement and cooking, as well as food safety, which is more challenging to monitor in such a program.

Peanut paste-based school meals might offer benefits as an alternative. Local production is possible, as is done for ready-to-use supplementary and therapeutic foods. Local ingredient sourcing could offer similar economic and sustainability advantages. Peanut pastes are food safe with long storage capabilities. They also provide a matrix into which varied ingredients can be added while maintaining organoleptic acceptability to children. Finally, in regions where current government-run HGSF programs suffer from inadequate funds and instability, local production and distribution of RUFs (ready to use foods) might improve reliability and impact school attendance, dropouts, and matriculation.

This study is a cluster-randomized, controlled, investigator-blinded superiority trial. Schools will be randomized to receive PM-RUF or local rice/millet flour for porridge. PM-RUF will contain peanut, palm oil, sugar, fat-free milk powder, and 0.5-1 RDA (recommended dietary allowances) of 14 micronutrients. Attendance will be tracked with the use of fingerprint biometric scanning each day.

• Study Type: Interventional
• Enrollment (Estimated): 6700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Kidd, BS; Phone Number: 3146089141; Email: kiddp@wustl.edu
• Study Contact Backup: Name: Mark Manary, MD; Phone Number: 314-454-2178; Email: manarymj@wustl.edu

Study Locations

• Ghana
  • Afayili, Ghana
    • Recruiting
    • Afayili Islamic primary school
  • Bofoyili, Ghana
    • Recruiting
    • Bofoyili E/P JHS
  • Bofoyili, Ghana
    • Recruiting
    • Bofoyili primary school
  • Jimile, Ghana
    • Recruiting
    • Jimle AME Zion JHS
  • Jimile, Ghana
    • Recruiting
    • Jimle/Guma R/C primary school
  • Kanimo, Ghana
    • Recruiting
    • Kanimo R/C JHS
  • Kpabia, Ghana
    • Recruiting
    • Kpabia Islamic JHS
  • Kpuligini, Ghana
    • Recruiting
    • Kpuligini Islamic primary school
  • Kusheli, Ghana
    • Recruiting
    • Kusheli Islamic primary school
  • Mbatinga, Ghana
    • Recruiting
    • Mbatinga Islamic primary school
  • Mion, Ghana
    • Recruiting
    • St. Anthony primary school
  • Nadundo, Ghana
    • Recruiting
    • Nadundo R/C JHS
  • Nalogno, Ghana
    • Recruiting
    • Nalogno Methodist JHS
  • Salankpang, Ghana
    • Recruiting
    • Salankpang A.M.E Zion primary school
  • Salwelsi, Ghana
    • Recruiting
    • Zakpalsi Issawiya E/A primary school
  • Sambu, Ghana
    • Recruiting
    • Sambu Islamic JHS
  • Sang, Ghana
    • Recruiting
    • Sang Islamic JHS
  • Sang, Ghana
    • Recruiting
    • Sang Zakaria Islamic JHS
  • Tuwua, Ghana
    • Recruiting
    • Tuwua R/C JHS
  • Yabogu, Ghana
    • Recruiting
    • Yabogu Islamic primary school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provision of signed (or thumb-printed) and dated informed consent form by parent/guardian
• Enrolled at level Basic 1 or higher in a participating school
• Parent/guardian stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating school
• 5 - 17 years of age

Exclusion Criteria:

• Known allergy to components of intervention or control study food or medications
• Condition requiring immediate hospitalization

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ready-to-use school food; Provision of peanut paste-based, milk-containing ready-to-use school food (PM-RUF)	Dietary supplement: Ready-to-use school food; 80 grams of peanut paste-based food containing skim milk powder, cowpea, peanuts, vegetable oil, and multiple micronutrients
Active Comparator: Standard school meal; Provision of flour made from millet + rice (local food) as school food	Dietary supplement: Standard meal; 300ml of porridge made with rice/millet flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance percentage	Percent attendance will be compared between PM-RUF and rice/millet flour groups using ordinal logistic regression with school as a random effect to account for clustered randomization, and including the covariates used in stratified, covariate-constrained randomization. Odds ratios with 95% confidence interval (CI) will be reported as well as model-derived median of differences with 95% CI.. Higher numbers are better. Maximum is 100%.	11-30 months from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dropout from school	Dropout is a binary outcome, defined as no attendance for 3 consecutive months, and the time from enrollment to last day of school attended will define time-to-dropout. Dropouts will be analyzed using time-to-event analysis with Cox proportional hazards regression. A random effect for school will be included to account for clustered randomization. The reported effect measure will be a hazard ratio with 95% CI. Censoring will occur at graduation from the school and moving away from school's catchment area.	11-30 months
Matriculation	Matriculation is a binary outcome defined by attendance at a subsequent grade after completing a school year. Logistic regression with a random effect for school will be used to analyze matriculation to subsequent school grade. This will be repeated for each school year included in the study. The reported effect measure will be an OR with 95% confidence interval.	11-30 months
Afternoon attendance percentage	Defined as attendance registered following lunch break. Percent afternoon attendance will be compared between PM-RUF and rice/millet flour groups using ordinal logistic regression with school as a random effect to account for clustered randomization. Odds ratios with 95% CI will be reported as well as model-derived medians of difference with 95% CI. Higher numbers are better. Maximum is 100%.	11-30 months
New Attendees	New attendees are defined as new enrollments in school after initiation of school feeding. The number of new attendees as a percent of the school population they join will be analyzed using ordinal logistic regression with school as random effect, and variables used in stratified, covariate-constrained randomization as covariates. Higher numbers are better.	11-30 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: United States Agency for International Development (USAID); University of Ghana
• Investigators: Principal Investigator: Mark Manary, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 202404055

Drug and device information, study documents

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