Preventing Malnutrition in Children Under Two Years of Age Approach

Sponsor
International Food Policy Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01072279
Collaborator
Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development (Other), United States Agency for International Development (USAID) (U.S. Fed), Catholic Relieve Services-Burundi (Other), Mercy Corps-Guatemala (Other)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Tubaramure (Burundi)
  • Other: Procomida (Guatemala)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16895 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Burundi: T24

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

Experimental: Burundi: TNFP

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

Experimental: Burundi: T18

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

No Intervention: Burundi: Control

Experimental: Guatemala: PROCOMIDA

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

Experimental: Guatemala: no family ration

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

Experimental: Guatemala: LNS

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

Experimental: Guatemala: Sprinkles

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

Experimental: Guatemala: reduced family ration

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

No Intervention: Guatemala: control

Outcome Measures

Primary Outcome Measures

  1. child nutritional status [Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

Secondary Outcome Measures

  1. household food security [Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

  2. household food and non-food consumption [Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

  3. maternal knowledge on infant and young child feeding (IYCF) and health [Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

  4. attitudes towards IYCF and health [Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

  5. morbidity [Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

  6. health care seeking behavior [Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 42 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Guatemala: pregnant mothers and subsequently their born children up to the age of 24 months;

  • Burundi: cross-sectional study: children 0 to 42 of age.

Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 CRS Burundi Bujumbura Burundi
2 Guatemala: Mercy Corps Guatemala: Coban Guatemala

Sponsors and Collaborators

  • International Food Policy Research Institute
  • Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development
  • United States Agency for International Development (USAID)
  • Catholic Relieve Services-Burundi
  • Mercy Corps-Guatemala

Investigators

  • Principal Investigator: Marie Ruel, PhD, IFPRI

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
International Food Policy Research Institute
ClinicalTrials.gov Identifier:
NCT01072279
Other Study ID Numbers:
  • 4001-IFPRI-00
First Posted:
Feb 22, 2010
Last Update Posted:
Feb 25, 2016
Last Verified:
Jan 1, 2013

Study Results

No Results Posted as of Feb 25, 2016