Objective Few studies targeting obesity in serious mental illness report clinically significant risk reduction, and none have been replicated within community settings or have demonstrated sustained outcomes after intervention withdrawal. This pragmatic clinical trial aims to replicate positive health outcomes demonstrated in a prior randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population. Methods Persons with serious mental illness and BMI>25 receiving services in three community mental health organizations were randomized to the 12-month In SHAPE program (health promotion coach and membership to a public fitness club) or to fitness club membership alone. Primary outcomes were weight and cardiorespiratory fitness (measured with the 6-Minute Walk Test) collected at baseline, 3-, 6-, 9-, 12-, and 18-months. Results Participants (N=210) were ethnically diverse (46% non-White) with mean baseline BMI=36.8±8.2. At 12-months In SHAPE (n=104) compared to a fitness club membership alone (n=106) contributed to greater reduction in weight and improved fitness. Primary outcomes were maintained at 18-months follow-up. Approximately half of In SHAPE participants (51% at 12-month program completion and 46% at 18-month follow-up) achieved clinically significant cardiovascular risk reduction (≥5% weight loss or >50 meter increase on the 6-Minute Walk Test). Conclusions Sustained weight loss and improved fitness can be achieved by community mental health organizations providing health promotion coaching and access to fitness facilities. Health promotion should be integrated into mental health services for persons with serious mental illness at risk for cardiovascular disease and early mortality.

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