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临床试验/NCT06397989
NCT06397989已完成不适用

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

Washington University School of Medicine20 个研究点 分布在 1 个国家目标入组 5,731 人开始时间: 2024年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5,731
试验地点
20
主要终点
Attendance percentage

研究概览

简要总结

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?

详细描述

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 meal (rice delivered, cash provided for additional ingredient purchase). 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

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.

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Standard school meal

Active Comparator

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

干预措施: Standard meal (Dietary Supplement)

Ready-to-use school food

Experimental

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

干预措施: Ready-to-use school food (Dietary Supplement)

结局指标

主要结局

Attendance percentage

时间窗: 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%.

次要结局

  • New Attendees(11-30 months)
  • Afternoon attendance percentage(11-30 months)
  • Dropout from school(11-30 months)
  • Matriculation(11-30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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