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

Child Nutrition Clinical Trial

— PEANUT-SMART  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397989
• Other study ID #: GHS-ERC: 012/01/24
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Mark Manary, MD
• Phone: 314-454-2178
• Email: manarymj[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5500
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Provision of signed (or thumb-printed) and dated informed consent form by parent/guardian
• 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

Related Conditions & MeSH terms

• Child Nutrition
• School Attendance
• School Feeding Programs

Intervention

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
• Standard meal
300ml of porridge made with rice/millet flour

Locations

Country	Name	City	State
Ghana	Afayili Islamic primary school	Afayili
Ghana	Bofoyili E/P JHS	Bofoyili
Ghana	Bofoyili primary school	Bofoyili
Ghana	Jimle AME Zion JHS	Jimle
Ghana	Jimle/Guma R/C primary school	Jimle
Ghana	Kanimo R/C JHS	Kanimo
Ghana	Kpabia Islamic JHS	Kpabia
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	Nalogno Methodist JHS	Nalogno
Ghana	Salankpang A.M.E Zion primary school	Salankpang
Ghana	Sambu Islamic JHS	Sambu
Ghana	Sang Islamic JHS	Sang
Ghana	Sang Zakaria Islamic JHS	Sang
Ghana	Tuwua R/C JHS	Tuwua
Ghana	Yabogu Islamic primary school	Yabogu
Ghana	Zakpalsi Issawiya E/A primary school	Zakpalsi

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	United States Agency for International Development (USAID), University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. 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	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
Secondary	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
Secondary	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
Secondary	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. The outcome will be reported as an OR with 95% CIs. Higher numbers are better.	11-30 months