Exercise to Enhance Smoking Cessation for Women at the YMCA
Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women
研究概览
详细说明
We propose a randomized controlled clinical trial to take place in the YMCA setting and to be delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise (CBT + EXERCISE) to CBT smoking cessation treatment plus an equal staff contact control (CBT + CONTACT). In order to promote transportability to the YMCA, the exercise program will be the YMCA's existing Personal Fitness Program, which like our CTQ exercise program, is guided by trained staff and requires participants to exercise at least 3 times per week.
If CBT + EXERCISE is found to be more efficacious than CBT + CONTACT when delivered at the YMCA by YMCA staff, then we will be well positioned to partner with the YMCA's initiative of Y Total Health to pursue widespread, national dissemination of this program. The proposed testing of the efficacy of the CTQ program in the YMCA setting is a necessary intermediate step in the eventual dissemination of the CTQ program.
Primary Aim. To determine the efficacy of CBT + EXERCISE compared with CBT + CONTACT when delivered in the YMCAs by YMCA staff to enhance the achievement and maintenance (3, 6, and 12 months follow-up) of smoking cessation (continuous abstinence) among healthy adult female smokers.
Hypothesis. Participants in the CBT + EXERCISE condition will have significantly greater continuous abstinence rates than those in the CBT + CONTACT condition at end-of-treatment, 3, 6, and 12 months follow-up.
Additional Questions of Interest.
1. To perform process-to-outcome analyses on the intermediate variables which influence the achievement and maintenance of smoking cessation among healthy female smokers. Specifically, to determine if exercise affects weight and/or weight concerns, negative affect associated with nicotine withdrawal, and/or self-efficacy and to determine if these hypothesized mediators affect the achievement and maintenance of smoking cessation.
To explore potential moderators of the treatment, such as baseline demographic and psychological characteristics (e.g., age, baseline mood) on smoking cessation outcomes.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
Rhode Island
-
Providence、Rhode Island、美国、02903
- The Mriam Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy female smokers
- ages 18 - 65
- Read and write English
- Regularly smoke 5 or more cigarettes a day
- Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than once a week or greater than 30 minutes of moderate exercise 2 times per week.
Exclusion Criteria:
- known history of cardiovascular
- pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension, chronic bronchitis, asthma, emphysema, and diabetes
- Any musculoskeletal problems that would limit exercise training such as knee or hip osteoarthritis or any other serious medical condition that might make exercise unsafe or unwise.
- The current use of smokeless tobacco, nicotine replacement therapy or other smoking cessation treatment, and currently using prescription medication that might impair exercise performance or tolerance, specifically beta-blockers or medications used for the treatment of hypertension
- Pregnant or planning to become pregnant within the next 12 months.
- Women hospitalized for a psychiatric disorder
- Receiving treatment for bipolar disorder or schizophrenia
- Current alcohol abuse or psychological problems when quitting in the past that required treatment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:CBT+ Contact
In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.
|
In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.
|
|
实验性的:CBT+ Exercise
Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery.
In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.
|
Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery.
In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Salivary Cotinine
大体时间:12 months posttreatment
|
Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.
|
12 months posttreatment
|
合作者和调查者
调查人员
- 首席研究员:Bess H Marcus, PhD、The Miriam Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.