Community-Based Lifestyle Intervention to Reduce CVD Risk &Disparities in Risk Principal Investigator: Thomas C. Keyserling, MD, MPH Large disparities in rates of cardiovascular disease (CVD) exist among subgroups defined by race, ethnicity, socioeconomic status, and geographic location. The reasons for these disparities are multi-factorial, yet an important known contributing factor is lifestyle, with disadvantaged populations consuming diets of poorer quality and being less physically active. Thus, we propose a 3 phase study to reduce CVD risk and disparities in risk by improving lifestyle factors which underlie CVD risk in Lenoir County, NC, a rural county with extremely high rates of CVD, especially among its large African American population. In Phase I, we will conduct a comprehensive formative evaluation, framed by the Socio-Ecological model, to assess individual, interpersonal, organizational, community, and policy factors relevant to CVD risk and risk reduction in this county. To do so, we will use a community-based participatory research approach and primarily qualitative methods. In Phase II, we propose a study that includes a lifestyle intervention given to all participants and a randomized controlled trial (RCT) of a weight loss intervention that will compare two programs designed to maintain weight loss. The rationale is that most participants should improve lifestyle and those who are obese should have the opportunity to lose weight and keep it off (generally the most challenging component of weight loss). At the outset, we will enroll 400 participants (also the sample for Dr. Patterson's study) into a communitybased lifestyle intervention program designed to improve diet quality and promote physical activity (all in the clinic-based DeWalt study to improve BP control will be encouraged to enroll). At 6 month follow-up, those who desire weight loss (N approximately 200) will take part in the RCT while the others will continue to receive the basic lifestyle intervention. All in the RCT will receive an intensive, weight loss intervention lasting 6 months, after which they will be randomly assigned to an intensive vs. standard maintenance of weight loss intervention. Community-wide policy and environmental change interventions will be implemented to support these programs and we will assess uptake by the different study groups. Outcomes, including costeffectiveness, will be assessed at 6, 12, 18, and 24 months. In Phase III, in addition to analysis and report writing, we will prepare effective inten/ention components ofthe study for dissemination.
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