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Clinical Trial Summary

The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.


Clinical Trial Description

In the United States and, indeed, worldwide the prevalence of overweight and obesity has increased at an unprecedented rate. Concomitant with this demographic change are increases in diseases including type 2 diabetes, cardiovascular disease and some cancers that are associated with body fatness. Strategies to reduce body weight have been largely unsuccessful, making it unlikely that our population will be made healthy simply by recommending that overweight people reduce their body fatness. There is evidence, however, that the impact of body fat on human health can be significantly attenuated by potentially achievable strategies. Such strategies require adequate intakes of essential nutrients, regular physical activity and strong self-esteem. The goal of the project is to reduce the risk of type 2 diabetes mellitus (T2DM) in overweight 9- to 10-year-old African American children through a multi-component community-based program. The specific objectives are to (1).Implement a randomly controlled 2-phase intervention involving a 2-week summer camp, and weekly & monthly reinforcement sessions over 2 years, that include nutrition education, physical activity promotion, and self-esteem and self-efficacy building and (2) Test effectiveness of the program after 1 and 2 years of intervention on insulin sensitivity, the primary outcome, and on secondary outcomes including body fatness, dietary intakes, physical activity, and self-esteem. Identifying an effective, community-based program that could reduce risk of type 2 diabetes in high-risk children would promote health, reduce disease and reduce health-care costs in the future. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01039116
Study type Interventional
Source University of California, Berkeley
Contact
Status Completed
Phase N/A
Start date March 2005
Completion date December 2009

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