Clinical trial NCT06397989: Peanut-based School Meals in Rural Ghana to Improve Attendance and Retention
Official title: Peanut-based School Meals in Rural Ghana to Improve Attendance and Retention
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: School Attendance
School Dropouts
School Enrollment
School Feeding Programs
Child Nutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: United States Agency for International Development (USAID)
First posted: 2024-05-03
Enrollment: 5500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized, controlled, investigator-blinded superiority trial. Schools will be randomized to receive PM-RUF or local flour for porridge. Randomization will be stratified / covariate-constrained by primary vs. junior secondary school, school size, and distance from a main road.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance percentage
timeFrame: 11-30 months from enrollment
Secondary outcomes:
measure: Dropout from school
timeFrame: 11-30 months
measure: Matriculation
timeFrame: 11-30 months
measure: Afternoon attendance percentage
timeFrame: 11-30 months
measure: New Attendees
timeFrame: 11-30 months
Other outcomes:
Locations:
city: Afayili
country: Ghana
facility: Afayili Islamic primary school
city: Bofoyili
country: Ghana
facility: Bofoyili E/P JHS
city: Bofoyili
country: Ghana
facility: Bofoyili primary school
city: Jimle
country: Ghana
facility: Jimle AME Zion JHS
city: Jimle
country: Ghana
facility: Jimle/Guma R/C primary school
city: Kanimo
country: Ghana
facility: Kanimo R/C JHS
city: Kpabia
country: Ghana
facility: Kpabia Islamic JHS
city: Kpuligini
country: Ghana
facility: Kpuligini Islamic primary school
city: Kusheli
country: Ghana
facility: Kusheli Islamic primary school
city: Mbatinga
country: Ghana
facility: Mbatinga Islamic primary school
city: Mion
country: Ghana
facility: St. Anthony primary school
city: Nadundo
country: Ghana
facility: Nadundo R/C JHS
city: Nalogno
country: Ghana
facility: Nalogno Methodist JHS
city: Salankpang
country: Ghana
facility: Salankpang A.M.E Zion primary school
city: Sambu
country: Ghana
facility: Sambu Islamic JHS
city: Sang
country: Ghana
facility: Sang Islamic JHS
city: Sang
country: Ghana
facility: Sang Zakaria Islamic JHS
city: Tuwua
country: Ghana
facility: Tuwua R/C JHS
city: Yabogu
country: Ghana
facility: Yabogu Islamic primary school
city: Zakpalsi
country: Ghana
facility: Zakpalsi Issawiya E/A primary school
Study officials:
affiliation: Washington University School of Medicine
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References: