Peanut-based School Meals in Rural Ghana to Improve Attendance and Retention

NCT06397989 | Active Not Recruiting

• 1 other identifier: 202404055
• Study Type: interventional
• Target: 5,800
• Locations: 1 country
• Sites: 20

Brief Summary

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?

Conditions

School Dropouts; School Enrollment; School Feeding Programs; Child Nutrition; School Attendance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Dropout from school

  11-30 months

• Matriculation

  11-30 months

• Afternoon attendance percentage

  11-30 months

• New Attendees

  11-30 months

Study Arms (2)

Ready-to-use school food

EXPERIMENTAL

Provision of peanut paste-based, milk-containing ready-to-use school food (PM-RUF)

Dietary Supplement: Ready-to-use school food

Standard school meal

ACTIVE COMPARATOR

Provision of rice + cash for cooks to purchase local ingredients to make a school meal

Dietary Supplement: Standard meal

Interventions

Ready-to-use school food DIETARY_SUPPLEMENT

80 grams of peanut paste-based food containing skim milk powder, cowpea, peanuts, vegetable oil, and multiple micronutrients

Ready-to-use school food

Standard meal DIETARY_SUPPLEMENT

Meal made with rice (cooked \~300 g/d) + local ingredients purchased by school cooks

Standard school meal

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• years of age

You may not qualify if:

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

Sponsors & Collaborators

• University of Ghana: collaborator
• Washington University School of Medicine: lead
• United States Agency for International Development (USAID): collaborator
• The Danish Dairy Research Foundation, Denmark: collaborator

Study Sites (20)

Afayili Islamic primary school

Afayili, Ghana

Location

Bofoyili E/P JHS

Bofoyili, Ghana

Location

Bofoyili primary school

Bofoyili, Ghana

Location

Jimle AME Zion JHS

Jimile, Ghana

Location

Jimle/Guma R/C primary school

Jimile, Ghana

Location

Kanimo R/C JHS

Kanimo, Ghana

Location

Kpabia Islamic JHS

Kpabia, Ghana

Location

Kpuligini Islamic primary school

Kpuligini, Ghana

Location

Kusheli Islamic primary school

Kusheli, Ghana

Location

Mbatinga Islamic primary school

Mbatinga, Ghana

Location

St. Anthony primary school

Mion, Ghana

Location

Nadundo R/C JHS

Nadundo, Ghana

Location

Nalogno Methodist JHS

Nalogno, Ghana

Location

Salankpang A.M.E Zion primary school

Salankpang, Ghana

Location

Zakpalsi Issawiya E/A primary school

Salwelsi, Ghana

Location

Sambu Islamic JHS

Sambu, Ghana

Location

Sang Islamic JHS

Sang, Ghana

Location

Sang Zakaria Islamic JHS

Sang, Ghana

Location

Tuwua R/C JHS

Tuwua, Ghana

Location

Yabogu Islamic primary school

Yabogu, Ghana

Location

Study Officials

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Neither participants nor outcomes assessors (who perform biometric attendance tracking) will be blinded to allocation to PM-RUF vs. rice meal. The trial statistician responsible for final analyses will remain blinded by use of letter assignment to each school. The code linking letter/school to intervention vs. control will remain locked and inaccessible to the trial statistician.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized, controlled, investigator-blinded superiority trial. Schools will be randomized to receive PM-RUF or local rice meal. Randomization will be stratified / covariate-constrained by primary vs. junior secondary school, school size, and distance from a main road.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 7, 2024
• Primary Completion: May 20, 2026
• Study Completion: June 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

GH (20)