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

This study has been completed.
Sponsor:
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)
Information provided by:
International Food Policy Research Institute
ClinicalTrials.gov Identifier:
NCT00210418
First received: September 13, 2005
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: Fortified food rations
Behavioral: Education and communication to improve feeding practices

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by International Food Policy Research Institute:

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

Estimated Enrollment: 1500
Study Start Date: May 2002
Study Completion Date: September 2005
Arms Assigned Interventions
Experimental: Preventive targeting
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 rations
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.
Behavioral: Education and communication to improve feeding practices
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.
Active Comparator: Recuperative targeting
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 rations
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.
Behavioral: Education and communication to improve feeding practices
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210418

Locations
Haiti
World Vision-Haiti
Hinche, Haiti
Sponsors and Collaborators
International Food Policy Research Institute
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)
Investigators
Principal Investigator: Marie T. Ruel, PhD International Food Policy Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00210418     History of Changes
Other Study ID Numbers: 212620-0S-IFPRI, 81051898
Study First Received: September 13, 2005
Last Updated: August 29, 2012
Health Authority: Haiti: Ministry of Health

Keywords provided by International Food Policy Research Institute:
Malnutrition
Infant nutrition
Food, fortified
Growth
Randomized controlled trials
Evaluation studies
Haiti

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 20, 2014