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The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.
In the United States, there is an epidemic of obesity and, as a result, an epidemic of diabetes. Obese individuals with pre-diabetes (defined as impaired fasting glucose or impaired glucose tolerance) are at high risk for progression to diabetes. A vast majority of these individuals also have an increased risk of cardiovascular disease because of concomitant risk factors, such as abdominal obesity, dyslipidemia, and elevated blood pressure. Intensive lifestyle interventions that focus on dietary change, physical activity, and behavior modification have demonstrated efficacy in achieving and maintaining clinically significant (>5%) weight loss in populations of patients with pre-diabetes. However, the effectiveness, cost-effectiveness, generalizability, and sustainability of such interventions in routine primary care settings remain unknown, and rigorous clinical research is needed.
The primary hypothesis for the E-LITE Study is that the CM intervention will reduce BMI more than the SM intervention, which in turn will reduce BMI more than usual care, over 15 months. Secondarily, we hypothesize that, compared with usual care, intervention participants will be associated with greater improvements in waist circumference, lipids, blood pressure, blood glucose, lifestyle behaviors, and psychosocial well-being. In addition, we will examine the durability of weight loss and behavioral change in the months after the initial 3-month intensive stage.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research
Self-management program (SM), Care management program (CM)
Palo Alto Medical Foundation, Los Altos Center
Palo Alto Medical Foundation
Published on BioPortfolio: 2014-08-27T03:24:21-0400
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