Abstract
BackgroundEfficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings.DesignE-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided α level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up.Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined.DiscussionThis study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.Trial registrationNCT00842426
Highlights
Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome
The present study aims to evaluate the feasibility and potential effectiveness of two lifestyle interventions, information technology-assisted self-management alone or SM combined with care management by a dietitian and exercise counselor, in comparison to usual care (UC)
The U.S health care system has evolved primarily to react to acute episodes of patient illness, and it remains largely so even though chronic disease that is largely preventable through lifestyle and behavior change has increasingly dominated patient demands and health care expenditures since the middle of the last century [58]
Summary
Diabetes mellitus affects nearly 24 million Americans (8% of the U.S population), and type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes [1,2]. A wide range of research has been underway related to translation of the DPP into real world settings, such as studies that assess cost-effective and generalizable methods of delivering evidence-based lifestyle modifications in small groups and over the Internet, as well as methods to sustain behavior change and weight loss [10,11,12]. Several randomized controlled trials have demonstrated the efficacy of Internet-based lifestyle interventions in overweight or obese individuals [18,19,20], including those at risk for type 2 diabetes [21]. Few studies have rigorously tested the feasibility and effectiveness of group- and Internet-based lifestyle interventions for weight management and risk reduction in primary care settings. Process measures will be evaluated to assess the extent of participation of patients in each intervention and the potential reach, adoption, implementation and maintenance of the interventions in primary care practice
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