Power of Peanuts School Feeding
NCT04349007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 880
Last updated 2022-12-23
Summary
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.
Conditions
- School Feeding Programs
- Nutrition Supplements
Interventions
- DIETARY_SUPPLEMENT
-
Standard meal
local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking
- DIETARY_SUPPLEMENT
-
School food ready-to-use
80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals
- DIETARY_SUPPLEMENT
-
School food ready-to-use plus Milk
80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals
Sponsors & Collaborators
-
University of Ghana
collaborator OTHER -
Project Peanut Butter, Ghana
collaborator UNKNOWN -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Mark Manary, MD · Washington University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-10
- Primary Completion
- 2022-08-05
- Completion
- 2022-08-05
Countries
- Ghana
Study Locations
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