Preventing Malnutrition in Children Under Two Years of Age Approach

NCT01072279 | Completed

• 1 other identifier: 4001-IFPRI-00
• Study Type: interventional
• Target: 16,895
• Locations: 2 countries
• Sites: 2

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. 1.Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status.
2. 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. 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

Keywords

Malnutrition;; Infant nutrition;; Fortified food; Linear growth; Cluster randomized controlled trials; Effectiveness; Impact evaluation studies; Burundi; Guatemala

Outcome Measures

Primary Outcomes (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 Outcomes (6)

• 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

Study Arms (10)

Burundi: T24

EXPERIMENTAL

Other: Tubaramure (Burundi)

Burundi: TNFP

EXPERIMENTAL

Other: Tubaramure (Burundi)

Burundi: T18

EXPERIMENTAL

Other: Tubaramure (Burundi)

Burundi: Control

NO INTERVENTION

Guatemala: PROCOMIDA

EXPERIMENTAL

Other: Procomida (Guatemala)

Guatemala: no family ration

EXPERIMENTAL

Other: Procomida (Guatemala)

Guatemala: LNS

EXPERIMENTAL

Other: Procomida (Guatemala)

Guatemala: Sprinkles

EXPERIMENTAL

Other: Procomida (Guatemala)

Guatemala: reduced family ration

EXPERIMENTAL

Other: Procomida (Guatemala)

Guatemala: control

NO INTERVENTION

Interventions

Tubaramure (Burundi) OTHER

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

Burundi: T18; Burundi: T24; Burundi: TNFP

Procomida (Guatemala) OTHER

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

Guatemala: LNS; Guatemala: PROCOMIDA; Guatemala: Sprinkles; Guatemala: no family ration; Guatemala: reduced family ration

Eligibility Criteria

• Age: Up to 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (2)

CRS Burundi

Bujumbura, Burundi

Location

Guatemala: Mercy Corps

Guatemala: Coban, Guatemala

Location

Related Publications (12)

• 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.

  PMID: 19161543 BACKGROUND

• 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.

  PMID: 18287379 BACKGROUND

• 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.

  PMID: 18280329 BACKGROUND

• 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.

  PMID: 17374671 BACKGROUND

• 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.

  PMID: 16060227 BACKGROUND

• 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.

  PMID: 15646314 BACKGROUND

• 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.

  PMID: 31858128 DERIVED

• 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.

  PMID: 31373374 DERIVED

• 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.

  PMID: 31268132 DERIVED

• 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.

  PMID: 30184223 DERIVED

• 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.

  PMID: 29546306 DERIVED

• 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.

  PMID: 27412269 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Marie Ruel, PhD

  IFPRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 22, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2013-01

Locations

GU (1); BU (1)