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Completed

NCT Number: NCT04349007

Power of Peanuts School Feeding

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Peanut Butter

Tamale, Ghana

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy school children

Exclusion criteria

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

Treatment and study plan

Standard meal

Dietary Supplement

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

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 plus Milk

Dietary Supplement

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

Primary outcomes

  1. Fluid cognition as measured by tests in NIH toolbox

    Time frame: 10 months

    Dimensional change card Sort, performance score

  2. Fluid cognition as measured by tests in NIH toolbox

    Time frame: 10 months

    Flanker inhibitory control and attention, performance score

  3. Fluid cognition as measured by tests in NIH toolbox

    Time frame: 10 months

    List sorting working memory, performance score

  4. Fluid cognition as measured by tests in NIH toolbox

    Time frame: 10 months

    Pattern comparison processing speed, performance score

Secondary outcomes

  1. Height-for-age Z

    Time frame: 10 months

    difference between enrollment and end of study height-for-age z score

  2. Change in body mass index

    Time frame: 10 months

    difference between enrollment and end of study body mass index

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Project Peanut Butter, Ghana
  • University of Ghana

Registry information

Official study title

Integrating the Power of Peanuts Into School Feeding Programs in Ghana

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2020
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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