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

说明(申请人提供)：吸烟是妇女发病和死亡的主要、可预防的原因；然而，大约18%的妇女继续吸烟。情绪相关的戒烟症状和对体重增加的担忧是成功戒烟的重大障碍，特别是在女性中。中等强度的运动(如快步走)是标准戒烟治疗的安全和低成本的补充，通过改善情绪和减轻戒烟期间的体重担忧，可能有助于戒烟过程。以前将中等强度运动作为戒烟治疗的随机对照试验一直受到运动计划依从性差、缺乏足够的控制条件以及缺乏对运动行为和戒烟结果的客观监测的困扰。因此，我们提出了一项随机对照试验(N=164)，以测试中等强度运动(150分钟/周)作为标准12周戒烟治疗(即，短暂的一次性基线咨询加上尼古丁贴片)在健康、先前不活跃的成年女性吸烟者中的疗效。根据我们最近完成的试点研究(R03 CA119747)，将使用一些技术来提高内部有效性，从而克服以前试验的弱点，包括：(A)使用与员工接触时间相等的健康比较条件；(B)直接观察所有运动和健康课程；(B)使用金钱激励措施来提高锻炼/健康计划的遵从性；以及(C)在12周的治疗期间和6个月的随访期内对吸烟状况进行多项客观评估(一氧化碳监测和唾液可替宁分析)。此外，我们将通过生态瞬时评估，探索情绪性戒断症状和体重担忧作为运动治疗的实时和参与者自然环境中的潜在机制。这项拟议的研究将为中等强度运动作为标准戒烟治疗的辅助手段的有效性提供明确的测试。如果初步的效果可以确定，那么将有必要进行进一步的研究，以测试更具传播性的中等强度锻炼计划，以建立在现实世界条件下的有效性(即，在缺乏金钱激励的情况下加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，以详细检查随着时间的推移吸烟失误和复发的决定因素，以及这些决定因素如何受到锻炼行为的影响。这将加深我们对成功戒烟与复发的理解，并有助于设计未来的戒烟干预措施。

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.