Nutributter Programming to Prevent Undernutrition: an Evaluation

Not Applicable

Completed

• Conditions: Undernutrition
• Interventions: Dietary Supplement: Nutributter Program; Other: Integrated Package

• Registration Number: NCT01552512
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1228

Inclusion Criteria

• Infants 6 to 12 months old
• Lives in Fort San Michel

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Exclusion Criteria

• Moderately or severely malnourished
• Peanut allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutributter 6 Months, Integrated Package	Nutributter Program	Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
Nutributter 3 Months, Integrated Package	Nutributter Program	Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
Nutributter 3 Months, Integrated Package	Integrated Package	Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
Nutributter 6 Months, Integrated Package	Integrated Package	Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.

Primary Outcome Measures

Name	Time	Method
Change in Length for Age	Once per month for 6 months, then once after 12 months.	Length (measured in centimeters) for age is an indicator of stunting, an outcome of chronic undernutrition during the first 2 years of life. Because our primary purpose is to prevent undernutrition, we are highly interested in this measurement.

Secondary Outcome Measures

Name	Time	Method
Change in Weight for Height	Once per month for 6 months, then once after 12 months	Weight (measured in kilograms) for height (measured in centimeters) is an indicator of moderate to severe acute malnutrition and if an infant is underweight, she/he could require immediate medical attention. We therefore weigh each participant to assess their current health status in this regard.

Trial Locations

Locations (1)

Hopital Fort San Michel; 🇭🇹 Cap Haitien, Haiti