The Lifestyle Intervention for the Treatment of Diabetes study (LIFT Diabetes): Design and baseline characteristics for a randomized translational trial to improve control of cardiovascular disease risk factors.

The prevalence of type 2 diabetes continues to increase in minority and underserved patients, who are also more likely to have poorer control of diabetes and related risk factors for complications. Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients who received an intensive lifestyle intervention, translating such findings into accessible programs is a major public health challenge. The purpose of this paper is to report the design and baseline characteristics of the Lifestyle Interventions for the Treatment of Diabetes study (LIFT Diabetes). The overall goal is to test the impact of a community-based lifestyle weight loss (LWL) intervention adapted from Look AHEAD on cardiovascular disease risk at 12-months and 24-months among minority and lower income diabetes patients. Secondary outcomes include body weight, physical activity, medication use, cost, resource utilization, and safety. The primary hypothesis being tested is that the LWL will result in 10% relative reduction in CVD risk compared to the DSM. We have randomized 260 overweight or obese adults with diabetes one of two 12-month interventions: a LWL condition delivered by community health workers or a diabetes self-management (DSM) education condition. The baseline demographic characteristics indicate that our sample is predominantly female, obese, low income, and ethnic minority. Translating evidence-based, lifestyle strategies, and targeting minority and underserved patients, will yield, if successful, a model for addressing the burden of diabetes and may favorably impact health disparities.