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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210418
• Other study ID #: 212620-0S-IFPRI
• Secondary ID: 81051898
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 29, 2012
• Start date: May 2002
• Est. completion date: September 2005

Study information

• Verified date: August 2012
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Haiti: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Haiti	World Vision-Haiti	Hinche

Sponsors (7)

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

Country where clinical trial is conducted

Haiti, 

References & Publications (5)

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 — View 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. — View 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. — View 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 cluste — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean z-scores (height-for-age, weight-for-age, weight-for-height) two years after intervention implemented
Primary	Prevalence of undernutrition (stunting, wasting, underweight) two years after implementation of intervention
Secondary	Maternal knowledge about child feeding practices recommended through behavioral intervention at 2 years after implementation of intervention;
Secondary	Feeding practices and other caregiving practices at 2 years after implementation of intervention