跳至主要内容
临床试验/NCT04349007
NCT04349007已完成不适用

Integrating the Power of Peanuts Into School Feeding Programs in Ghana

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
880
试验地点
1
主要终点
Fluid cognition as measured by tests in NIH toolbox

研究概览

简要总结

This will be a two-phase protocol. Phase 1 will include the development of the peanut-based school food, and a small formative research study on the acceptability and consumption of the school food study intervention. This will occur among children 5-12 yr in the Mion district, 60 school aged children between 6-12 years old will be recruited to participate in a 3 week consumption and acceptability study. An integral part of the food development process is acceptability testing. A child must like and want to eat a new food if it is to be consumed as prescribed and effective in potential improving linear growth and cognitive performance. This study will confirm that food developed for the school feeding clinical trial will be consumed as dosed and what additional snack food offerings may be useful in encouraging consumption.

Phase 2 will be a individually randomized, investigator blinded, controlled clinical effectiveness trial of a peanut-based school meal with and without milk powder compared to a control meal for linear growth and cognitive performance. 880 children 5 to 12 years old, healthy, enrolled in primary school, including kindergarten at 6 selected schools in the Mion district will be randomized to receive one of three school foods, a peanut-based food with milk, a peanut-based food without milk and a control group composed of commonly available tuber/cereal. The sample size accounts for up to 15% attrition for a final sample size of 750 with a total 250 eligible children enrolled in each group. Enrolled children will receive the meal daily during the school lunch period for an entire school year. At enrollment and upon completion, anthropometric measurements and body composition data will be collected and a tablet- based, language independent cognitive test battery will be administered. Basic demographic information and school attendance information will be collected as well.

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

Single (Investigator)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy school children

排除标准

  • severe malnutrition
  • chronic debilitation disease
  • peanut or milk allergy
  • not attending school

结局指标

主要结局

Fluid cognition as measured by tests in NIH toolbox

时间窗: 10 months

Dimensional change card Sort, performance score

次要结局

  • Height-for-age Z(10 months)
  • Change in body mass index(10 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验