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

April 17, 2026 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance percentage
Time Frame: 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, 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dropout from school
Time Frame: 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.
11-30 months
Matriculation
Time Frame: 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.
11-30 months
Afternoon attendance percentage
Time Frame: 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%.
11-30 months
New Attendees
Time Frame: 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, and variables used in stratified, covariate-constrained randomization as covariates. Higher numbers are better.
11-30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Agency for International Development (USAID)
University of Ghana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Manary, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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