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

NCT ID: NCT00210418

Last Updated: 2012-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2005-09-30

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.

Conditions

Malnutrition

Keywords

Malnutrition; Infant nutrition; Food, fortified; Growth; Randomized controlled trials; Evaluation studies; Haiti

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fortified food rations

Intervention Type: DIETARY_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.

Education and communication to improve feeding practices

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Fortified food rations

Intervention Type: DIETARY_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.

Education and communication to improve feeding practices

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: collaborator

Food and Nutrition Technical Assistance Project

UNKNOWN

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

World Vision

OTHER

Sponsor Role: collaborator

Government of Germany

OTHER_GOV

Sponsor Role: collaborator

United Nations World Food Programme (WFP)

OTHER

Sponsor Role: collaborator

International Food Policy Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Marie T. Ruel, PhD

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Locations

World Vision-Haiti

Hinche, , Haiti

Countries

Haiti

References

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.

Reference Type: RESULT

PMID: 15646314 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18280329 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16060227 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18287379 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20392883 (View on PubMed)

Other Identifiers

81051898

Identifier Type: -

Identifier Source: secondary_id

212620-0S-IFPRI

Identifier Type: -

Identifier Source: org_study_id