Exercise to Enhance Smoking Cessation for Women at the YMCA
Condition: Smoking
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): CBT+ Contact; CBT+ Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; Aerobic Exercise; Women; YMCA