Preventing Malnutrition in Children Under Two Years of Age Approach

Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Other: Tubaramure (Burundi); Other: Procomida (Guatemala)

• Study Type: Interventional
• Enrollment (Actual): 16895
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burundi
  • Bujumbura, Burundi
    • CRS Burundi
• Guatemala
  • Guatemala: Coban, Guatemala
    • Guatemala: Mercy Corps

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
household food security	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	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	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	Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
morbidity	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	Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo

Collaborators and Investigators

• Sponsor: International Food Policy Research Institute
• Collaborators: United States Agency for International Development (USAID); Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development; Catholic Relieve Services-Burundi; Mercy Corps-Guatemala
• Investigators: Principal Investigator: Marie Ruel, PhD, IFPRI

Publications and helpful links

General Publications

• Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
• Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.
• Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.
• Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
• Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.
• Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
• Leroy JL, K Olney D, Bliznashka L, Ruel M. Tubaramure, a Food-Assisted Maternal and Child Health and Nutrition Program in Burundi, Increased Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity: A Cluster-Randomized Controlled Trial. J Nutr. 2020 Apr 1;150(4):945-957. doi: 10.1093/jn/nxz295.
• Leroy JL, Olney DK, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2019 Dec 1;149(12):2219-2227. doi: 10.1093/jn/nxz175.
• Olney DK, Leroy JL, Bliznashka L, Ruel MT. A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children. J Nutr. 2019 Oct 1;149(10):1833-1842. doi: 10.1093/jn/nxz133.
• Olney DK, Leroy J, Bliznashka L, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Reduces Child Stunting in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Sep 1;148(9):1493-1505. doi: 10.1093/jn/nxy138.
• Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program, Reduces Child Stunting in Burundi: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Mar 1;148(3):445-452. doi: 10.1093/jn/nxx063.
• Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program in Burundi, Increases Maternal and Child Hemoglobin Concentrations and Reduces Anemia: A Theory-Based Cluster-Randomized Controlled Intervention Trial. J Nutr. 2016 Aug;146(8):1601-8. doi: 10.3945/jn.115.227462. Epub 2016 Jul 13.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 17, 2010
• First Submitted That Met QC Criteria: February 19, 2010
• First Posted (Estimate): February 22, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Effectiveness; Malnutrition;; Infant nutrition;; Fortified food; Linear growth; Cluster randomized controlled trials; Impact evaluation studies; Burundi; Guatemala
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: 4001-IFPRI-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No