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Preventing Malnutrition in Children Under Two Years of Age Approach

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tubaramure (Burundi)
Procomida (Guatemala)
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Malnutrition;, Infant nutrition;, Fortified food, Linear growth, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Burundi, Guatemala

Eligibility Criteria

undefined - 42 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CRS Burundi
  • Guatemala: Mercy Corps

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Burundi: T24

Burundi: TNFP

Burundi: T18

Burundi: Control

Guatemala: PROCOMIDA

Guatemala: no family ration

Guatemala: LNS

Guatemala: Sprinkles

Guatemala: reduced family ration

Guatemala: control

Arm Description

Outcomes

Primary Outcome Measures

child nutritional status

Secondary Outcome Measures

household food security
household food and non-food consumption
maternal knowledge on infant and young child feeding (IYCF) and health
attitudes towards IYCF and health
morbidity
health care seeking behavior

Full Information

First Posted
February 17, 2010
Last Updated
February 23, 2016
Sponsor
International Food Policy Research Institute
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
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1. Study Identification

Unique Protocol Identification Number
NCT01072279
Brief Title
Preventing Malnutrition in Children Under Two Years of Age Approach
Official Title
Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Food Policy Research Institute
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

4. Oversight

Data Monitoring Committee
No

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition;, Infant nutrition;, Fortified food, Linear growth, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Burundi, Guatemala

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16895 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Burundi: T24
Arm Type
Experimental
Arm Title
Burundi: TNFP
Arm Type
Experimental
Arm Title
Burundi: T18
Arm Type
Experimental
Arm Title
Burundi: Control
Arm Type
No Intervention
Arm Title
Guatemala: PROCOMIDA
Arm Type
Experimental
Arm Title
Guatemala: no family ration
Arm Type
Experimental
Arm Title
Guatemala: LNS
Arm Type
Experimental
Arm Title
Guatemala: Sprinkles
Arm Type
Experimental
Arm Title
Guatemala: reduced family ration
Arm Type
Experimental
Arm Title
Guatemala: control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Tubaramure (Burundi)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Procomida (Guatemala)
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
morbidity
Time Frame
Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Ruel, PhD
Organizational Affiliation
IFPRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRS Burundi
City
Bujumbura
Country
Burundi
Facility Name
Guatemala: Mercy Corps
City
Guatemala: Coban
Country
Guatemala

12. IPD Sharing Statement

Citations:
PubMed Identifier
19161543
Citation
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.
Results Reference
background
PubMed Identifier
18287379
Citation
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.
Results Reference
background
PubMed Identifier
18280329
Citation
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.
Results Reference
background
PubMed Identifier
17374671
Citation
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.
Results Reference
background
PubMed Identifier
16060227
Citation
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.
Results Reference
background
PubMed Identifier
15646314
Citation
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.
Results Reference
background
PubMed Identifier
31858128
Citation
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.
Results Reference
derived
PubMed Identifier
31373374
Citation
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.
Results Reference
derived
PubMed Identifier
31268132
Citation
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.
Results Reference
derived
PubMed Identifier
30184223
Citation
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.
Results Reference
derived
PubMed Identifier
29546306
Citation
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.
Results Reference
derived
PubMed Identifier
27412269
Citation
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.
Results Reference
derived

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Preventing Malnutrition in Children Under Two Years of Age Approach

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