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

描述(由申请人提供)：有严重精神疾病(SMI)的人的死亡率是没有SMI的人的三倍，主要是由于心血管疾病(CVD)。吸烟是SMI心血管疾病的最大贡献者。尽管全国吸烟率在下降，但尼古丁成瘾对至少一半的SMI成年人来说是一个根深蒂固的问题，符合指南的戒烟治疗率很低。在SMI工作的绝大多数人表示，他们想退出。在SMI的试验中，药物疗法和行为疗法的结合提高了禁酒率，但尚未在社区环境中进行测试或广泛使用。此外，已经观察到戒烟会增加体重，肥胖在SMI中已经很普遍。运动可能会改善尼古丁戒断症状，减少戒烟期间的体重增加，但在SMI中还没有关于在戒烟治疗中加入运动的研究。由于吸烟、缺乏运动、不健康饮食和肥胖等所有心血管危险行为的负担都非常高，因此迫切需要在这一脆弱人群中进行联合健康行为改变干预，特别是在吸烟者中。这项R-01应用的目标是开发和测试一种创新的、可扩展的干预措施，该干预措施可以广泛采用，以促进SMI的长期戒烟、改善体力活动和体重控制。我们的多学科研究团队在SMI患者的健康行为改变方面拥有独一无二的资质，结合了戒烟、减肥和运动干预方面的领先专家，并在测试短信技术方面拥有丰富的知识，以维持和支持行为改变。我们提出了凯旋试验，这是一项基于社区精神卫生组织的双臂试验，将检验一项假设，即一项为期18个月的综合、实用的烟草戒烟计划结合锻炼和体重咨询将在实现长期戒烟、身体健康和保持体重方面优于常规治疗(TAU)对照组。我们将招募220名患有SMI的成年人参加马里兰州两个社区心理健康组织中的一个，他们目前是吸烟者，表示有戒烟兴趣。我们将根据戒烟意愿进行分层，并随机分配参与者接受：1)TAU，转介到戒烟专线；2)为期18个月的干预，包括：i)由健康教练提供的团体和个人戒烟和体重咨询，并根据参与者的戒烟准备情况量身定做；ii)社区诊所开出的varenicline或安非他酮+尼古丁替代疗法的药物治疗；iii)集体锻炼和健身房准入；以及iv)支持健康行为改变的短信。主要结果将是18个月后7天的吸烟率；次要结果将包括体重、6分钟步行测试、饮食和10年内发生心血管事件的风险。改善所有心血管危险行为对于降低SMI的过早死亡率至关重要，需要在社区环境中采取创新的综合干预措施。凯旋试验将测试这样一种方法，它可以接触到广泛的SMI吸烟者，并且实施起来很实用。

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.