Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00210418
Study type Interventional
Source International Food Policy Research Institute
Contact
Status Completed
Phase N/A
Start date May 2002
Completion date September 2005

See also
  Status Clinical Trial Phase
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Compositeā„¢ to Treat Undernourished Young Children N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A