Power of Peanuts School Feeding

School Feeding Programs Clinical Trial

Official title:

Integrating the Power of Peanuts Into School Feeding Programs in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349007
• Other study ID #: 202011110
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: August 5, 2022

Study information

• Verified date: December 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Healthy school children

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Nutrition Supplements
• School Feeding Programs

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Ghana	Project Peanut Butter	Tamale

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Project Peanut Butter, Ghana, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid cognition as measured by tests in NIH toolbox	Dimensional change card Sort, performance score	10 months
Primary	Fluid cognition as measured by tests in NIH toolbox	Flanker inhibitory control and attention, performance score	10 months
Primary	Fluid cognition as measured by tests in NIH toolbox	List sorting working memory, performance score	10 months
Primary	Fluid cognition as measured by tests in NIH toolbox	Pattern comparison processing speed, performance score	10 months
Secondary	Height-for-age Z	difference between enrollment and end of study height-for-age z score	10 months
Secondary	Change in body mass index	difference between enrollment and end of study body mass index	10 months