Design, recruitment and start up of a primary care weight loss trial targeting African American and Hispanic adults

Primary care offices are critical access points for obesity treatment, but evidence for approaches that can be implemented within these settings is limited. The Think Health! ((i)Vive Saludable!) Study was designed to assess the feasibility and effectiveness of a behavioral weight loss program, adapted from the Diabetes Prevention Program, for implementation in routine primary care. Recruitment of clinical sites targeted primary care practices serving African American and Hispanic adults. The randomized design compares (a) a moderate-intensity treatment consisting of primary care provider counseling plus additional counseling by an auxiliary staff member (i.e., lifestyle coach), with (b) a low-intensity, control treatment involving primary care provider counseling only. Treatment and follow up duration are 1 to 2 years. The primary outcome is weight change from baseline at 1 and 2 years post-randomization. Between November 2006 and January 2008, 14 primary care providers (13 physicians; 1 physician assistant) were recruited at five clinical sites. Patients were recruited between October 2007 and November 2008. A total of 412 patients were pre-screened, of whom 284 (68.9%) had baseline assessments and 261 were randomized, with the following characteristics: 65% African American; 16% Hispanic American; 84% female; mean (SD) age of 47.2 (11.7) years; mean (SD) BMI of 37.2(6.4) kg/m(2); 43.7% with high blood pressure; and 18.4% with diabetes. This study will provide insights into the potential utility of moderate-intensity lifestyle counseling delivered by motivated primary care clinicians and their staff. The study will have particular relevance to African Americans and women. (C) 2010 Elsevier Inc. All rights reserved.