Power of Peanuts School Feeding

NCT04349007 | Completed

• 1 other identifier: 202011110
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

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.

Conditions

School Feeding Programs; Nutrition Supplements

Outcome Measures

Primary Outcomes (4)

• Fluid cognition as measured by tests in NIH toolbox

  Dimensional change card Sort, performance score

  10 months

• Fluid cognition as measured by tests in NIH toolbox

  Flanker inhibitory control and attention, performance score

  10 months

• Fluid cognition as measured by tests in NIH toolbox

  List sorting working memory, performance score

  10 months

• Fluid cognition as measured by tests in NIH toolbox

  Pattern comparison processing speed, performance score

  10 months

Secondary Outcomes (2)

• Height-for-age Z

  10 months

• Change in body mass index

  10 months

Study Arms (3)

Standard meal

ACTIVE COMPARATOR

local porridge with a vitamin and mineral sprinkle powder that will be mixed in

Dietary Supplement: Standard meal

School food ready-to-use

EXPERIMENTAL

peanut-based school food ready-to-use

Dietary Supplement: School food ready-to-use

School food ready-to-use plus Milk

EXPERIMENTAL

peanut-based school food ready-to-use with milk

Dietary Supplement: School food ready-to-use plus Milk

Interventions

Standard meal DIETARY_SUPPLEMENT

local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking

Standard meal

School food ready-to-use DIETARY_SUPPLEMENT

80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals

School food ready-to-use

School food ready-to-use plus Milk DIETARY_SUPPLEMENT

80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals

School food ready-to-use plus Milk

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy school children

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Ghana: collaborator
• Project Peanut Butter, Ghana: collaborator

Study Sites (1)

Project Peanut Butter

Tamale, Ghana

Location

Related Publications (1)

• 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.

  PMID: 37567391 DERIVED

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: September 10, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

GH (1)