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Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
Fortified food rations
Education and communication to improve feeding practices
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, Food, fortified, Growth, Randomized controlled trials, Evaluation studies, Haiti

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program Exclusion Criteria: None

Sites / Locations

  • World Vision-Haiti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preventive targeting

Recuperative targeting

Arm Description

This arm targeted pregnant and lactating women as well as children 6-23.9 months of age to receive BCC and food assistance. A total of 27 months of enrollment in this program arm was possible.

This arm targeted pregnant and lactating women as well as mothers of malnourished children (WAZ <-2 zscores) between 6 and 59 months of age. A total of 18 months of enrollment was possible in this program arm.

Outcomes

Primary Outcome Measures

Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented
Prevalence of undernutrition (stunting, wasting, underweight) two years after implementation of intervention

Secondary Outcome Measures

Maternal knowledge about child feeding practices recommended through behavioral intervention at 2 years after implementation of intervention;
Feeding practices and other caregiving practices at 2 years after implementation of intervention

Full Information

First Posted
September 13, 2005
Last Updated
August 29, 2012
Sponsor
International Food Policy Research Institute
Collaborators
Cornell University, Food and Nutrition Technical Assistance Project, United States Agency for International Development (USAID), World Vision, Government of Germany, United Nations World Food Programme (WFP)
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1. Study Identification

Unique Protocol Identification Number
NCT00210418
Brief Title
Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years
Official Title
Prevention or Cure: A Comparison of the Effectiveness of Targeting Food Supplements to Malnourished Children Compared to Universal Targeting of Children Under Two in Haiti
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Food Policy Research Institute
Collaborators
Cornell University, Food and Nutrition Technical Assistance Project, United States Agency for International Development (USAID), World Vision, Government of Germany, United Nations World Food Programme (WFP)

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to compare two approaches to targeting donated supplementary food to young children. The study compares the effectiveness of the widely-used curative approach where targeting is based on the child's poor nutritional status to a preventive approach which targets children in poor communities solely on the basis of age and provides supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting approaches will also be assessed.
Detailed Description
Under-nutrition is widespread among young children in poor countries. In many countries one of the programmatic responses has been distribution of supplementary food to under-nourished children and, often, their families. Traditionally, children under five years have been identified based on low weight-for-age or other anthropometric indicators, and those below a certain cut-off have received supplements. Typically this results in supplementation of many children in the 3-5 year age range, since they are most likely to display cumulative deficits in height and weight, and thus fall below the chosen cut-off. However, there has been increasing evidence that the most effective period to ensure benefit from supplementary food is when children are 6 to 24 months of age. This is the period of highest growth velocity among humans and thus a period when most growth faltering occurs. Based on this evidence, the current study aims to assess the effectiveness and cost-effectiveness of a preventive approach that targets children under 24 months as compared to the traditional "curative" approach that targets malnourished (and usually older) children under the age of 5 years. The comparison is made in the programmatic context of a US Title II food aid distribution program implemented by an international non-governmental organization in rural Haiti. This programmatic context is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study has also involved development of new nutrition education materials and tools, aimed at enabling caregivers to prevent malnutrition. In addition, a range of program operational issues will be studied in order to yield results useful to other implementers of similar interventions. Comparison: Comparisons will be made at the level of the program site, with service delivery points randomized either to target food supplements as in the past, based on the child's nutritional status, or to target preventively based on age. Pregnant women and lactating women with infants under 6 months of age will receive supplements under both targeting models. Effectiveness will be assessed based on two cross-sectional surveys, at baseline and two years after full implementation of the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition, Infant nutrition, Food, fortified, Growth, Randomized controlled trials, Evaluation studies, Haiti

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (false)

8. Arms, Groups, and Interventions

Arm Title
Preventive targeting
Arm Type
Experimental
Arm Description
This arm targeted pregnant and lactating women as well as children 6-23.9 months of age to receive BCC and food assistance. A total of 27 months of enrollment in this program arm was possible.
Arm Title
Recuperative targeting
Arm Type
Active Comparator
Arm Description
This arm targeted pregnant and lactating women as well as mothers of malnourished children (WAZ <-2 zscores) between 6 and 59 months of age. A total of 18 months of enrollment was possible in this program arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortified food rations
Intervention Description
The Fortified food rations were included in both arms, but targeted to all children 6-24 months of age in the 'preventive' arm and to malnourished children (WAZ <-2 Z-scores) in the 'recuperative arm. Food rations included Corn-Soy Blend, lentils, oil and wheat.
Intervention Type
Behavioral
Intervention Name(s)
Education and communication to improve feeding practices
Intervention Description
The education and communication to improve infant and young child feeding was an integral part of the intervention. In the preventive arm, this intervention was targeted to pregnant and lactating mothers and mothers of children 0-24 months of age. The education was done using mother's groups In the recuperative arm, the BCC intervention was only targeted to pregnant and lactating women and mothers of malnourished children under the age of five.
Primary Outcome Measure Information:
Title
Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented
Title
Prevalence of undernutrition (stunting, wasting, underweight) two years after implementation of intervention
Secondary Outcome Measure Information:
Title
Maternal knowledge about child feeding practices recommended through behavioral intervention at 2 years after implementation of intervention;
Title
Feeding practices and other caregiving practices at 2 years after implementation of intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie T. Ruel, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
World Vision-Haiti
City
Hinche
Country
Haiti

12. IPD Sharing Statement

Citations:
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
result
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
result
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
result
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
result
PubMed Identifier
20392883
Citation
Donegan S, Maluccio JA, Myers CK, Menon P, Ruel MT, Habicht JP. Two food-assisted maternal and child health nutrition programs helped mitigate the impact of economic hardship on child stunting in Haiti. J Nutr. 2010 Jun;140(6):1139-45. doi: 10.3945/jn.109.114272. Epub 2010 Apr 14.
Results Reference
result

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Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years

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