Clinical trial NCT04349007: Power of Peanuts School Feeding
Official title: Integrating the Power of Peanuts Into School Feeding Programs in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: School Feeding Programs
Nutrition Supplements
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: Project Peanut Butter, Ghana
First posted: 2020-04-16
Enrollment: 880
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy school children

Exclusion Criteria:

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

Primary outcomes:
measure: Fluid cognition as measured by tests in NIH toolbox
timeFrame: 10 months
measure: Fluid cognition as measured by tests in NIH toolbox
timeFrame: 10 months
measure: Fluid cognition as measured by tests in NIH toolbox
timeFrame: 10 months
measure: Fluid cognition as measured by tests in NIH toolbox
timeFrame: 10 months
Secondary outcomes:
measure: Height-for-age Z
timeFrame: 10 months
measure: Change in body mass index
timeFrame: 10 months
Other outcomes:
Locations:
city: Tamale
country: Ghana
facility: Project Peanut Butter
Study officials:
affiliation: Washington University School of Medicine
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References: