Exercise to Enhance Smoking Cessation for Women at the YMCA
Completed · Phase 2/Phase 3
Conditions studied: Smoking
In brief
Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious than contact control when delivered at the YMCA by YMCA staff, then the investigators will be well positioned to partner with the YMCA to pursue widespread, national dissemination of this program.
Key facts
- Study ID
- NCT01615380
- Run by
- The Miriam Hospital
- People needed
- 408
- Starts
- 2006-09-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2012-06-08
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- The Mriam Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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