Preventing Malnutrition in Children Under Two Years of Age Approach

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by International Food Policy Research Institute
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01072279
First received: February 17, 2010
Last updated: January 1, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • morbidity [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 9184
Study Start Date: April 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   up to 42 Months
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072279

Contacts
Contact: Jef L Leroy, PhD j.leroy@cgiar.org
Contact: Deanna Olney, PhD d.olney@cgiar.org

Locations
Burundi
CRS Burundi Recruiting
Bujumbura, Burundi
Principal Investigator: Avril Armstrong, PhD         
Guatemala
Guatemala: Mercy Corps Not yet recruiting
Guatemala: Coban, Guatemala
Principal Investigator: Susan Richter, PhD         
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:

Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT01072279     History of Changes
Other Study ID Numbers: 4001-IFPRI-00
Study First Received: February 17, 2010
Last Updated: January 1, 2013
Health Authority: Burundi: Ministry of Health
Guatemala: Ministry of Health

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
Nutrition Disorders
Child Nutrition Disorders

ClinicalTrials.gov processed this record on September 22, 2014