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