Nutributter Programming to Prevent Undernutrition: an Evaluation
NPPU
Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
1 other identifier
interventional
1,228
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 6, 2018
August 1, 2018
2.3 years
February 15, 2012
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Weight for Height
Once per month for 6 months, then once after 12 months
Study Arms (3)
MSPP Integrated Package
NO INTERVENTIONParticipants 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.
Nutributter 3 Months, Integrated Package
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- Infants 6 to 12 months old
- Lives in Fort San Michel
You may not qualify if:
- Moderately or severely malnourished
- Peanut allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- University of California, Daviscollaborator
- World Bankcollaborator
- United Nations World Food Programme (WFP)collaborator
Study Sites (1)
Hopital Fort San Michel
Cap-Haïtien, Haiti
Related Publications (1)
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.
PMID: 24225356DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lora Iannotti, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
March 13, 2012
Study Start
June 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
August 6, 2018
Record last verified: 2018-08