Nutributter Programming to Prevent Undernutrition: an Evaluation (NPPU)

The Washington University

Status

Completed

Conditions

Undernutrition

Treatments

Dietary Supplement: Nutributter Program

Other: Integrated Package

Study type

Interventional

Funder types

Other

Identifiers

NCT01552512

FSM-001-201101760

Details and patient eligibility

About

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.

Enrollment

1,228 patients

Sex

All

Ages

6 to 12 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infants 6 to 12 months old
Lives in Fort San Michel

Exclusion criteria

Moderately or severely malnourished
Peanut allergy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,228 participants in 3 patient groups

MSPP Integrated Package

No Intervention group

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.

Nutributter 3 Months, Integrated Package

Experimental group

Description:

Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.

Treatment:

Other: Integrated Package

Dietary Supplement: Nutributter Program

Nutributter 6 Months, Integrated Package

Experimental group

Description:

Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.

Treatment: