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

Not Applicable

• Conditions: Child Nutrition; School Enrollment; School Attendance; School Dropouts; School Feeding Programs
• Interventions: Dietary Supplement: Ready-to-use school food; Dietary Supplement: Standard meal

• Registration Number: NCT06397989
• Lead Sponsor: Washington University School of Medicine

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?

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 Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Study Start: 2024-05-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ready-to-use school food	Ready-to-use school food	Provision of peanut paste-based, milk-containing ready-to-use school food (PM-RUF)
Standard school meal	Standard meal	Provision of flour made from millet + rice (local food) as school food

Primary Outcome Measures

Name	Time	Method
Attendance percentage	11-30 months from enrollment	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. 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%.

Secondary Outcome Measures

Name	Time	Method
Afternoon attendance percentage	11-30 months	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%.
Dropout from school	11-30 months	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.
Matriculation	11-30 months	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.
New Attendees	11-30 months	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. The outcome will be reported as an OR with 95% CIs. Higher numbers are better.

Trial Locations

Locations (20)

Bofoyili E/P JHS; 🇬🇭 Bofoyili, Ghana

Jimle/Guma R/C primary school; 🇬🇭 Jimle, Ghana

Kpuligini Islamic primary school; 🇬🇭 Kpuligini, Ghana

Kusheli Islamic primary school; 🇬🇭 Kusheli, Ghana

Mbatinga Islamic primary school; 🇬🇭 Mbatinga, Ghana

St. Anthony primary school; 🇬🇭 Mion, Ghana

Nadundo R/C JHS; 🇬🇭 Nadundo, Ghana

Sambu Islamic JHS; 🇬🇭 Sambu, Ghana

Sang Islamic JHS; 🇬🇭 Sang, Ghana

Sang Zakaria Islamic JHS; 🇬🇭 Sang, Ghana

Nalogno Methodist JHS; 🇬🇭 Nalogno, Ghana

Yabogu Islamic primary school; 🇬🇭 Yabogu, Ghana

Tuwua R/C JHS; 🇬🇭 Tuwua, Ghana

Zakpalsi Issawiya E/A primary school; 🇬🇭 Zakpalsi, Ghana

Bofoyili primary school; 🇬🇭 Bofoyili, Ghana

Jimle AME Zion JHS; 🇬🇭 Jimle, Ghana

Kanimo R/C JHS; 🇬🇭 Kanimo, Ghana

Afayili Islamic primary school; 🇬🇭 Afayili, Ghana

Kpabia Islamic JHS; 🇬🇭 Kpabia, Ghana

Salankpang A.M.E Zion primary school; 🇬🇭 Salankpang, Ghana