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

SMI 综合戒烟、运动和体重管理试验

• 批准号: 8764228
• 负责人: Gail L. Daumit
• 金额: $ 74.1万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-11 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8764228
• 关键词: Abstinence; Acute; Adopted; Adult; Affect; American Heart Association; Behavior Therapy; Body Weight decreased; Body mass index; Bupropion; Cardiovascular Diseases; Caring; Cessation of life; Clinic; Clinical Trials; Combination Drug Therapy; Communities; Counseling; Diet; Drops; Enrollment; Epidemic; Event; Exercise; Future; General Population; Guidelines; Health; Health Status; Health behavior change; High Prevalence; Hospitalization; Individual; Interdisciplinary Study; Intervention; Joints; Maryland; Mediator of activation protein; Mental Health; Modeling; Nicotine Dependence; Nicotine Withdrawal; Obesity; Outcome; Participant; Patient Self-Report; Patients; Persons; Pharmacotherapy; Physical Fitness; Physical activity; Population; Premature Mortality; Prevalence; Probability; Psychiatric Diagnosis; Qualifying; Quality of life; Randomized; Readiness; Reporting; Research; Research Personnel; Risk; Risk Behaviors; Risk Factors; SF-12; Sampling; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Subgroup; Symptoms; Technology; Testing; Text; Time; Tobacco; Tobacco smoking; Visit; Vulnerable Populations; Walking; Weight; Weight Gain; Weight maintenance regimen; Withdrawal Symptom; Withholding Treatment; arm; base; behavior change; cardiovascular disorder risk; cardiovascular risk factor; community setting; cost; cost effectiveness; design; experience; good diet; health disparity; high risk; improved; innovation; interest; mental health organization; mortality; nicotine replacement; premature; primary outcome; programs; public health relevance; quitline; randomized trial; secondary outcome; severe mental illness; smoking cessation; smoking prevalence; successful intervention; treatment as usual; two-arm study; varenicline; weight maintenance

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.

描述（由申请人提供）：患有严重精神疾病的人（SMI）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中CVD的最大贡献者。即使全国吸烟率下降，尼古丁成瘾也是至少一半的SMI成年人的根深蒂固的问题，而指导方案限制的戒烟率也很少。他们想辞职的绝大多数国家。结合药物治疗和行为治疗可提高SMI试验中的禁欲，但尚未在社区环境中进行测试或广泛使用。此外，通过戒烟观察到体重增加，肥胖症在SMI中已经很普遍。运动可以改善尼古丁的戒断症状并减轻戒烟尝试时的体重增加，但是在SMI中，没有对戒烟治疗进行锻炼的研究。所有CVD风险行为的负担非常高：吸烟；身体不活跃；不健康的饮食；在这个脆弱的人群中，尤其是在那些吸烟的人群中，肥胖，健康行为改变干预措施迫切需要采取干预措施。该R-01应用的目的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，以促进长期戒烟，改善SMI的体育锻炼和体重控制。我们的多学科研究团队在SMI的人中具有独特的资格，可以在健康行为变化中，结合了戒烟，减肥和运动干预方面的主要专家，并在测试文本消息传递技术方面知识渊博，以维持和支持行为改变。我们提出了Triumph试验，这是一项基于社区心理健康组织的两臂试验，该试验将检验以下假设：一个18个月的综合，实用的烟草戒烟计划整合运动和体重咨询将在实现长期吸烟，身体健身和体重维持的延长方面像往常一样控制（TAU）控制（TAU）。我们将招募220名成年人与SMI一起参加马里兰州的两个社区心理健康组织之一，他们目前的吸烟者对退出感兴趣。我们将通过准备在1或6个月内设置退出日期进行分层，并随机分配参与者接受：1）TAU转介到退出线路或2）18个月的干预措施，其中包括：i）i）由健康教练组成的团体和个人戒烟和体重咨询，并量身定制为参与者准备戒烟； ii）在社区诊所规定的葡萄烯素或安非他酮 +尼古丁替代疗法的药物治疗； iii）小组运动和健身房访问； iv）支持健康行为的文本消息传递。主要结果将是7天 - 在18个月时戒烟的盛行率；次要结果将包括体重，步行6分钟，饮食和CVD事件的10年风险。改善所有CVD风险行为对于降低SMI的过早死亡率至关重要，并且需要在社区环境中进行创新的综合干预措施。胜利试验将测试这种方法，该方法可以达到SMI的广泛吸烟者，并且可以实施。