Preventing Malnutrition in Children Under Two Years of Age Approach

NCT01072279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16895

Last updated 2016-02-25

No results posted yet for this study

Summary

A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both feasible and highly effective. The study's principal aim was to compare a newly designed preventive approach with the traditional (recuperative) food assisted MCHN program approach, and therefore included only two comparison groups: one group of communities that was randomly assigned to the preventive approach and another group assigned to the recuperative approach. For logistical and financial reasons, the study did not include a randomized control group receiving no intervention.

The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the preventive approach was more effective than the recuperative approach at preventing child undernutrition - but it left a number of questions unanswered.

The present study will address several of these questions, which will allow to further refine the PM2A approach, facilitate its replication in different contexts, and maximize its impact and cost-effectiveness in future programming. The study will be conducted in Guatemala and Burundi. The key research objectives are:

1. Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status.
2. Optimal composition and size of food rations in PM2A: Assess the differential and absolute impact of varying the size and types of foods incorporated in the food ration of the PM2A. More specifically, assess the differential effect of different sizes of family food rations, and assess the impact of substituting the individual food ration with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or micronutrient Sprinkles.
3. Optimal timing and duration of PM2A: Assess the differential and absolute impact of varying the timing and duration of exposure to PM2A on child nutritional status.

Conditions

  • Malnutrition

Interventions

OTHER

Tubaramure (Burundi)

Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices

OTHER

Procomida (Guatemala)

Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices

Sponsors & Collaborators

  • Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development

    collaborator UNKNOWN
  • United States Agency for International Development (USAID)

    collaborator FED
  • Catholic Relieve Services-Burundi

    collaborator UNKNOWN
  • Mercy Corps-Guatemala

    collaborator UNKNOWN
  • International Food Policy Research Institute

    lead OTHER

Principal Investigators

  • Marie Ruel, PhD · IFPRI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
42 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Burundi
  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072279 on ClinicalTrials.gov