Nutributter Programming to Prevent Undernutrition: an Evaluation (NPPU)
Primary Purpose
Undernutrition
Status
Completed
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
Nutributter Program
Integrated Package
Sponsored by
About this trial
This is an interventional prevention trial for Undernutrition focused on measuring Stunting, Hidden Hunger, Diarrhea, Vitamin A Deficiency
Eligibility Criteria
Inclusion Criteria:
- Infants 6 to 12 months old
- Lives in Fort San Michel
Exclusion Criteria:
- Moderately or severely malnourished
- Peanut allergy
Sites / Locations
- Hopital Fort San Michel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
MSPP Integrated Package
Nutributter 3 Months, Integrated Package
Nutributter 6 Months, Integrated Package
Arm Description
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.
Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01552512
First Posted
February 15, 2012
Last Updated
August 2, 2018
Sponsor
Washington University School of Medicine
Collaborators
University of California, Davis, World Bank, United Nations World Food Programme (WFP)
1. Study Identification
Unique Protocol Identification Number
NCT01552512
Brief Title
Nutributter Programming to Prevent Undernutrition: an Evaluation
Acronym
NPPU
Official Title
Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of California, Davis, World Bank, United Nations World Food Programme (WFP)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
Keywords
Stunting, Hidden Hunger, Diarrhea, Vitamin A Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MSPP Integrated Package
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nutributter 3 Months, Integrated Package
Arm Type
Experimental
Arm Description
Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
Arm Title
Nutributter 6 Months, Integrated Package
Arm Type
Experimental
Arm Description
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutributter Program
Other Intervention Name(s)
Nutriset
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Integrated Package
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Length for Age
Description
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.
Time Frame
Once per month for 6 months, then once after 12 months.
Secondary Outcome Measure Information:
Title
Change in Weight for Height
Description
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.
Time Frame
Once per month for 6 months, then once after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants 6 to 12 months old
Lives in Fort San Michel
Exclusion Criteria:
Moderately or severely malnourished
Peanut allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora Iannotti, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Fort San Michel
City
Cap Haitien
Country
Haiti
12. IPD Sharing Statement
Citations:
PubMed Identifier
24225356
Citation
Iannotti LL, Dulience SJ, Green J, Joseph S, Francois J, Antenor ML, Lesorogol C, Mounce J, Nickerson NM. Linear growth increased in young children in an urban slum of Haiti: a randomized controlled trial of a lipid-based nutrient supplement. Am J Clin Nutr. 2014 Jan;99(1):198-208. doi: 10.3945/ajcn.113.063883. Epub 2013 Nov 13.
Results Reference
derived
Learn more about this trial
Nutributter Programming to Prevent Undernutrition: an Evaluation
We'll reach out to this number within 24 hrs