Power of Peanuts School Feeding

Study Overview
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Brief Summary
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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.

Official Title
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Integrating the Power of Peanuts Into School Feeding Programs in Ghana

Conditions
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School Feeding Programs, Nutrition Supplements

Intervention / Treatment
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* Dietary Supplement: Standard meal
* Dietary Supplement: School food ready-to-use
* Dietary Supplement: School food ready-to-use plus Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy school children Exclusion Criteria: severe malnutrition chronic debilitation disease peanut or milk allergy not attending school

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard meal<br>local porridge with a vitamin and mineral sprinkle powder that will be mixed in | Dietary Supplement: Standard meal<br>* local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking<br>|
| Experimental: School food ready-to-use<br>peanut-based school food ready-to-use | Dietary Supplement: School food ready-to-use<br>* 80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals<br>|
| Experimental: School food ready-to-use plus Milk<br>peanut-based school food ready-to-use with milk | Dietary Supplement: School food ready-to-use plus Milk<br>* 80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height-for-age Z | difference between enrollment and end of study height-for-age z score | 10 months | 
| Change in body mass index | difference between enrollment and end of study body mass index | 10 months |