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Preventing Malnutrition in Children Under Two Years of Age Approach

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072279
First Posted: February 22, 2010
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
Information provided by (Responsible Party):
International Food Policy Research Institute
  Purpose

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 Intervention
Malnutrition Other: Tubaramure (Burundi) Other: Procomida (Guatemala)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by International Food Policy Research Institute:

Primary Outcome Measures:
  • child nutritional status [ Time Frame: Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]

Secondary Outcome Measures:
  • household food security [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]
  • household food and non-food consumption [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]
  • maternal knowledge on infant and young child feeding (IYCF) and health [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]
  • attitudes towards IYCF and health [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]
  • morbidity [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]
  • health care seeking behavior [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ]

Enrollment: 16895
Study Start Date: April 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 42 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072279


Locations
Burundi
CRS Burundi
Bujumbura, Burundi
Guatemala
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
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT01072279     History of Changes
Other Study ID Numbers: 4001-IFPRI-00
First Submitted: February 17, 2010
First Posted: February 22, 2010
Last Update Posted: February 25, 2016
Last Verified: January 2013

Keywords provided by International Food Policy Research Institute:
Malnutrition;
Infant nutrition;
Fortified food
Linear growth
Cluster randomized controlled trials
Effectiveness
Impact evaluation studies
Burundi
Guatemala

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders