YMCA Exercise Intervention for Smoking Cessation Study
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Cigarette smoking is the leading cause of death and disability in the United States. Although
      smoking has declined since 1964, it is still very common among some groups of people. One
      such group is persons with emotional symptoms and disorders. There has been little success in
      developing treatments for smoking cessation for smokers with affective disturbances.

      Recent work suggests that being sensitive to, and less tolerant of, stress is associated with
      many problems in daily life. People with high 'stress sensitivity' tend to use avoidant
      strategies to cope with their stress, like smoking. Also, people with high levels of stress
      sensitivity report stronger beliefs that smoking will reduce negative feelings. They also
      report having a harder time quitting and in fact, are less successful at doing so. This
      information suggests that stress sensitivity is important to target during smoking cessation
      treatment for smokers with affective vulnerabilities.

      This clinical trial will evaluate a treatment that integrates exercise to reduce stress
      sensitivity among high stress sensitive smokers. It builds directly from our recent work and
      we now seek to adapt it to a more a more accessible and sustainable application. Results will
      provide important information on the benefit of an integrated intervention that could be used
      in the community for smokers at great risk for relapse and who do not benefit from existing
      alternative treatments. This study is the first to test an intervention for stress sensitive
      smokers and has the potential to help at-risk individuals experience quitting success and,
      ultimately, reduce the burden of tobacco-related cancers in Texas.
    

Detailed description: 
      Experimental Group. Participants will select a YMCA branch and be assigned a personal fitness
      instructor who will act as their case manager, overseeing the integrated exercise-based
      intervention for smoking cessation. Guided by our pilot data showing efficacy and
      tolerability of the exercise dose, the exercise intervention consists of 75 minutes/week of
      aerobic training at vigorous-intensity for 15 weeks2. As in the previous study, the aerobic
      training component will be completed on a treadmill and target training intensity will be
      self-selected at 60% to 85% of age-predicted heart rate reserve (i.e., vigorous intensity) 2.
      In order to maximize adherence, the days of the week and training progression schedule will
      be individualized for each participant based on initial fitness level, travel, and any other
      issues.

      The participant and fitness instructor will meet for three sessions during the first week of
      exercise training. During the first session, the fitness instructor will describe the program
      (i.e., treatment model and aims), set a target quit attempt for week 6, develop an exercise
      training schedule, and supervise the first exercise session to ensure the participant is
      exercising properly. After two more supervised exercise sessions during the first week, the
      pair will meet one day per week during the following 14 weeks of the study. The fitness
      instructors will be responsible for monitoring sessions weekly, problem-solving any
      difficulties, adjusting the aerobic and/or resistance training regimen as appropriate, and
      entering the participants exercise data into the (REDCap) database specifically designed for
      the study.

      At the beginning of week 3, the fitness instructor will connect the participant with the
      quitline (i.e., warm transfer). The Tobacco quitlines are now available in every U.S. state
      via a national quitline portal, 1-800-QUIT-NOW, and have become the major vehicle through
      which smoking cessation services are delivered in the U.S.73. All participants will receive
      the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco
      Quitline (https://www.quitnow.net/texas/); we will use a 'warm transfer' (i.e., call the
      quitline in the presence of the smoker and put them on the phone for the intake interview).
      Call 1 is an assessment and planning call, Call 2 is a pre-quit date call, Call 3 is a quit
      date call, and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving
      calls if they have not quit. Overall, the counseling protocol aims to (1) provide
      cognitive-behavioral smoking cessation and relapse prevention tools, tailored to the
      individual smoker's characteristics and; (2) provide medication management and advice
      regarding nicotine patch use and adherence support, with the goal of completing a full course
      of medication - in this case, 8 weeks of transdermal nicotine patch use.

      On the target quit day, the fitness instructor will provide the participants with Nicoderm
      CQ®, 24-hour transdermal nicotine patches (TNP) as part of the study. We chose to provide the
      patch for 8 weeks because longer than 8 weeks does not appear to improve treatment
      efficacy10. We chose the TNP because of the extensive empirical literature supporting its
      effectiveness and safety, its ease of use, and its relatively benign side effect profile that
      have led to its approval as an over-the-counter medication74. Quitline staff provide
      instructions on dose and tapering schedule in a fashion consistent with that used in previous
      trials with a similar formulation of the patch10.

      Control Group. The intervention procedures for this group are identical to the Experimental
      Group group except that the target training intensity will be self-selected at 20% to 40% of
      age-predicted heart rate reserve (i.e., light intensity).
    

Intervention name(s): Aerobic exercise; Smoking Cessation Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will work with a YMCA personal trainer to engage in aerobic exercise 3 times a week (25 mins each) for 15 weeks.; Individuals will work with a national quitline to help them with their smoking cessation goals and make a quit attempt at week 5 of the program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment