Nutributter Programming to Prevent Undernutrition: an Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti

Conditions
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Undernutrition

Intervention / Treatment
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* Dietary Supplement: Nutributter Program
* Other: Integrated Package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants 6 to 12 months old Lives in Fort San Michel Exclusion Criteria: Moderately or severely malnourished Peanut allergy

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: MSPP Integrated Package<br>Participants in this arm only receive the standard care offered by the Ministry of Health (MSPP)called the Integrated Package. During the trial, they do not receive Nutributter. | |
| Experimental: Nutributter 3 Months, Integrated Package<br>Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package. | Dietary Supplement: Nutributter Program<br>* Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.<br>* Other names: Nutriset;Other: Integrated Package<br>* The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).<br>|
| Experimental: Nutributter 6 Months, Integrated Package<br>Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package. | Dietary Supplement: Nutributter Program<br>* Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.<br>* Other names: Nutriset;Other: Integrated Package<br>* The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Length for Age | 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. | Once per month for 6 months, then once after 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight for Height | 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. | Once per month for 6 months, then once after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stunting, Hidden Hunger, Diarrhea, Vitamin A Deficiency