Power of Peanuts School Feeding

The Washington University

Status: Completed

Conditions: Nutrition Supplements; School Feeding Programs

Treatments: Dietary Supplement: School food ready-to-use plus Milk; Dietary Supplement: School food ready-to-use; Dietary Supplement: Standard meal

Study type: Interventional

Funder types: Other

Identifiers

NCT04349007

202011110

Details and patient eligibility

About

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.

Enrollment: 880 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy school children

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

880 participants in 3 patient groups

Standard meal

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard meal

School food ready-to-use

Experimental group

Description:

peanut-based school food ready-to-use

Treatment:

Dietary Supplement: School food ready-to-use

School food ready-to-use plus Milk

Experimental group

Description:

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

Treatment:

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