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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
880
local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking
80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals
80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals
Project Peanut Butter
Tamale, Ghana
Fluid cognition as measured by tests in NIH toolbox
Dimensional change card Sort, performance score
Time frame: 10 months
Fluid cognition as measured by tests in NIH toolbox
Flanker inhibitory control and attention, performance score
Time frame: 10 months
Fluid cognition as measured by tests in NIH toolbox
List sorting working memory, performance score
Time frame: 10 months
Fluid cognition as measured by tests in NIH toolbox
Pattern comparison processing speed, performance score
Time frame: 10 months
Height-for-age Z
difference between enrollment and end of study height-for-age z score
Time frame: 10 months
Change in body mass index
difference between enrollment and end of study body mass index
Time frame: 10 months
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