Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
880 participants
INTERVENTIONAL
2021-09-10
2022-08-05
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Standard meal
local porridge with a vitamin and mineral sprinkle powder that will be mixed in
Standard meal
local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking
School food ready-to-use
peanut-based school food ready-to-use
School food ready-to-use
80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals
School food ready-to-use plus Milk
peanut-based school food ready-to-use with milk
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
Interventions
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Standard meal
local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking
School food ready-to-use
80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* chronic debilitation disease
* peanut or milk allergy
* not attending school
5 Years
12 Years
ALL
Yes
Sponsors
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University of Ghana
OTHER
Project Peanut Butter, Ghana
UNKNOWN
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Mark Manary, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Project Peanut Butter
Tamale, , Ghana
Countries
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References
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Stephenson KB, Wegner DR, Hershey TG, Doty T, Davis E, Steiner-Asiedu M, Saalia FK, Shani I, Manary MJ. Effect of Peanut Paste-based Ready-to-use School Meals With and Without Milk on Fluid Cognition in Northern Ghana: A Randomized Controlled Trial. Am J Clin Nutr. 2023 Oct;118(4):782-791. doi: 10.1016/j.ajcnut.2023.08.001. Epub 2023 Aug 9.
Other Identifiers
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202011110
Identifier Type: -
Identifier Source: org_study_id