Community-based participatory research: The roxbury: Heart and sole clinical trial

Background: A disproportionate number of African Americans (AA) have cardiovascular (CV) risk factors/disease. Central to eliminating disparities in CV outcomes for AA, are interventions that are culturally appropriate, feasible, clinically effective and sustainable. Toward that goal, Community-Based Participatory Research (CBPR) provides a model for engaging the community in the design and conduct of clinical trials, enhancing the probability of success. Objectives: The purpose of this study was to test a nurse-led, multidisciplinary, multifactorial heart disease prevention program (HDPP), emanating from CBPR, in the AA community. Methods: This randomized, clinical trial emphasizes CBPR. Pilot HDPP work at the Roxbury Heart Center enabled a strong grassroots presence in this community including a partnership with Cherishing Our Hearts and Souls (a broadly based community coalition), focus groups with community residents and peer mentors. These strategies should enhance recruitment, retention and clinical outcomes. After baseline assessment/informed consent, participants were randomized to control (attention/education only) or intervention (supervised exercise, healthy eating demonstrations, smoking cessation, cognitive-behavioral strategies and self-management skills) and attended 12 weekly and 3 monthly 3-hour sessions. Results: The study has concluded the active treatment phase (24 weeks) and analysis of outcomes is underway. Conclusions: CBPR methods have been integral to the conduct of this clinical trial. To insure successful outcomes and translation of findings, collaboration between researchers and the community of interest is essential. Successful implementation of a community- based HDPP in this underserved, at-risk community could contribute to the overall goal of improving the CV health outcomes of African Americans.