NCT00210418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

First QC Date

September 13, 2005

Last Update Submit

August 29, 2012

Conditions

Malnutrition

Keywords

MalnutritionInfant nutritionFood, fortifiedGrowthRandomized controlled trialsEvaluation studiesHaiti

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Preventive targeting

EXPERIMENTAL

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.

Dietary Supplement: Fortified food rationsBehavioral: Education and communication to improve feeding practices

Recuperative targeting

ACTIVE COMPARATOR

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.

Dietary Supplement: Fortified food rationsBehavioral: Education and communication to improve feeding practices

Interventions

Fortified food rationsDIETARY_SUPPLEMENT

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.

Preventive targetingRecuperative targeting
Education and communication to improve feeding practicesBEHAVIORAL

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.

Preventive targetingRecuperative targeting

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Vision-Haiti

Hinche, Haiti

Location

Related Publications (5)

  • 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: 15646314RESULT

  • 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: 18280329RESULT

  • 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: 16060227RESULT

  • 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: 18287379RESULT

  • 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.

    PMID: 20392883RESULT

MeSH Terms

Conditions

Malnutrition

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Marie T. Ruel, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2002

Study Completion

September 1, 2005

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

HA(1)