Nutributter Programming to Prevent Undernutrition: an Evaluation (NPPU)

August 2, 2018 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Haiti
      • Cap Haitien, Haiti
        • Hopital Fort San Michel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Moderately or severely malnourished
  • Peanut allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: MSPP Integrated Package
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
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
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.
Other Names:
  • Nutriset
Other: Integrated Package
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).
EXPERIMENTAL: Nutributter 6 Months, Integrated Package
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
Dietary supplement: Nutributter Program
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.
Other Names:
  • Nutriset
Other: Integrated Package
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

University of California, Davis
World Bank
United Nations World Food Programme (WFP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2011

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSM-001-201101760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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