Trial of Integrated Smoking Cessation, Exercise, and Weight Management in SMI

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DESCRIPTION (provided by applicant): Persons with serious mental illness (SMI) have three times higher mortality rates than those without SMI, primarily due to cardiovascular disease (CVD). Tobacco smoking is the single largest contributor to CVD in SMI. Even while nationally smoking rates are dropping, nicotine addiction is an entrenched problem for at least half of SMI adults, and rates of guideline-concordant cessation treatment are minimal. The vast majority with SMI state they would like to quit. Combination pharmacotherapy and behavioral treatment increases abstinence rates in trials in SMI, but has not been tested or widely used in community settings. Moreover, weight gain has been observed with smoking abstinence, and obesity is already widespread in SMI. Exercise may improve nicotine withdrawal symptoms and reduce weight gain during a quit attempt, but no studies of exercise added to smoking cessation treatment have been done in SMI. With extraordinarily high burden of all the CVD risk behaviors: smoking; physical inactivity; unhealthy diet; and obesity, combined health behavior change interventions are urgently needed in this vulnerable population, especially in those who smoke. The objective of this R-01 application is to develop and test an innovative, scalable intervention that could be widely adopted to promote long-term smoking abstinence, improved physical activity and weight control in SMI. Our multidisciplinary research team is uniquely qualified in health behavior change in persons with SMI, combining leading experts in smoking cessation, weight loss and exercise interventions and knowledgeable in testing text messaging technology to sustain and support behavior change. We propose the TRIUMPH Trial, a community mental health organization-based, two-arm trial that will test the hypothesis that an 18-month comprehensive, practical tobacco smoking cessation program integrating exercise and weight counseling will be superior to a treatment as usual (TAU) control in achieving prolonged smoking abstinence, physical fitness and weight maintenance. We will enroll 220 adults with SMI attending one of two community mental health organizations in Maryland, who are current smokers expressing interest in quitting. We will stratify by readiness to set a quit date within 1 or 6 months and randomly assign participants to receive: 1) TAU with referral to a quit line or 2) the 18-month intervention that will include: i) group and individual smoking cessation and weight counseling by a health coach and tailored to participants' readiness to quit; ii) pharmacotherapy with either varenicline, or bupropion + nicotine replacement therapy, prescribed in the community clinic; iii) group exercise and gym access; and iv) text messaging supporting health behavior change. The primary outcome will be 7-day point- prevalence smoking abstinence at 18 months; secondary outcomes will include weight, 6-minute walk test, diet and 10-year risk of CVD events. Improving all CVD risk behaviors is critical to decrease premature mortality in SMI, and will require innovative, integrated interventions in community settings. The TRIUMPH Trial will test such an approach that reaches a broad range of smokers with SMI and is practical to implement.