Efficacy of brisk walking as a smoking cessation treatment adjunct among women

描述（由申请人提供）：吸烟是导致妇女发病和死亡的主要、可预防的原因;然而，约18%的妇女继续吸烟。与情绪有关的戒断症状和对体重增加的担忧是成功戒烟的重要障碍，特别是在女性中。中等强度运动（例如，快走）是标准戒烟治疗的安全且低成本的辅助物，其可通过在戒烟期间改善情绪和减轻体重担忧来帮助戒烟过程。以前的RCT检查中等强度运动作为戒烟治疗一直困扰着与运动计划的依从性差，缺乏足够的控制条件，缺乏客观的监测运动行为和戒烟结果。因此，我们提出了一项RCT（N = 164）来测试中等强度运动（150分钟/周）作为标准12周戒烟治疗（即，在健康的、以前不活动的成年女性吸烟者中进行短暂的一次性基线咨询加尼古丁贴片。与我们最近完成的试点研究一致（R 03 CA 119747），将使用许多技术来增强内部有效性，从而克服以前试验的弱点，包括：（a）使用等同于工作人员接触时间的健康比较条件;（B）直接观察所有运动和健康课程;（B）使用金钱激励来增加对锻炼/健康计划的依从性;和（c）在12周治疗期间和6个月随访期间对吸烟状况进行多个客观评估（CO监测和唾液可替宁分析）。此外，我们将探索情感戒断症状和体重问题作为运动治疗的潜在机制，在实时和参与者的自然环境中，通过生态瞬时评估。这项拟议的研究将提供一个确定性的测试，中等强度的运动作为辅助标准戒烟治疗的疗效。如果可以建立初步疗效，那么进一步的研究将有必要测试更多可传播的中等强度运动计划，以建立在现实世界条件下的有效性（即，在没有金钱激励的情况下增强对锻炼计划的坚持）。无论治疗结果如何，拟议的EMA方案将提供丰富的数据来源，以详细检查吸烟失败和复发的决定因素，以及这些决定因素如何受到运动行为的影响。这将进一步加深我们对成功戒烟与复吸的理解，并有助于设计未来的戒烟干预措施。 公共卫生相关性：吸烟是妇女死亡和疾病的主要、可预防的原因。中等强度运动（即，快步走）可能会提高标准戒烟计划的效果，如尼古丁贴片，特别是在女性中。这项研究将比较12周的中等强度运动（150分钟/周）加尼古丁贴片与12周的基于视频的健康计划加尼古丁贴片对164名健康，以前不活动的女性吸烟者的戒烟结果和尼古丁戒断症状的影响。

DESCRIPTION (provided by applicant): Cigarette smoking is the leading, preventable cause of morbidity and mortality among women; however, approximately 18 percent of women continue to smoke cigarettes. Mood-related withdrawal symptoms and concerns about weight-gain are significant barriers to successful smoking cessation, especially among women. Moderate intensity exercise (e.g., brisk walking) is a safe and low-cost adjunct to standard smoking cessation treatments that may aid in the smoking cessation process by improving mood and attenuating weight concerns during smoking cessation. Previous RCTs examining moderate intensity exercise as a smoking cessation treatment have been plagued by poor compliance with the exercise program, lack of adequate control conditions, and lack of objective monitoring of exercise behavior and smoking cessation outcomes. Thus, we propose an RCT (N = 164) to test the efficacy of moderate intensity exercise (150 min/week) as an adjunct to a standard 12-week smoking cessation treatment (i.e., brief one-time baseline counseling plus the nicotine patch) among healthy, previously inactive adult female smokers. Consistent with our recently completed pilot study (R03 CA119747), a number of techniques will be used to enhance internal validity and thus overcome the weaknesses of previous trials, including: (a) use of a wellness comparison condition that equates for staff contact time; (b) direct observation of all exercise and wellness sessions; (b) use of monetary incentives to increase compliance with the exercise/wellness programs; and (c) multiple objective assessments of smoking status (CO monitoring and saliva cotinine analysis) during the 12-week treatment and during a 6-month follow- up period. Additionally, we will explore affective withdrawal symptoms and weight concerns as potential mechanisms of the exercise treatment in real-time and in participants natural environments via ecological momentary assessment. The proposed study will provide a definitive test of the efficacy of moderate intensity exercise as an adjunct to standard smoking cessation treatment. If initial efficacy can be established, then further research will be warranted to test more disseminable moderate intensity exercise programs to establish effectiveness in real-world conditions (i.e., enhancing adherence to exercise programs in the absence of monetary incentives). Regardless of treatment outcomes, the proposed EMA protocol will provide a rich source of data to conduct a detailed examination of the determinants of smoking lapses and relapse over time and how these determinants are impacted by exercise behavior. This will further our understanding of successful smoking cessation versus relapse and aid in the design of future smoking cessation interventions. PUBLIC HEALTH RELEVANCE: Cigarette smoking is the leading, preventable cause of death and disease among women. Moderate intensity exercise (i.e., brisk walking) may improve the efficacy of standard smoking cessation programs, such as the nicotine patch, especially among women. This study will compare the effects of 12 weeks of moderate intensity exercise (150 min/week) plus the nicotine patch versus 12 weeks of a video-based wellness program plus the nicotine patch on smoking cessation outcomes and nicotine withdrawal symptoms among 164 healthy, previously inactive, female smokers.