The getting physical on cigarettes trial: rationale and methods

Smoking cessation success rates are generally dismal amongst self-quitters, with a discrepancy apparent among sexes with women having lower cessation rates than men (Osler, Prescott, Godtfredsen, Hein, & Schnohr, 1999; Royce, Corbett, Sorensen, & Ockene, 1997; Wetter et al., 1999). The Getting Physical on Cigarettes project aims to be the first clinical trial to appropriately evaluate the effectiveness of home-based lifestyle exercise maintenance program in assisting women to prevent smoking relapse and maintain exercise and weight following the termination of a structured and supervised exercise and nicotine replacement therapy (NRT) smoking cessation intervention. This paper outlines the rationale and methods of the trial - a supervised exercise and NRT program lasting 14 weeks, which is followed by a home-based exercise maintenance program. Sedentary female smokers will be randomized into one of four research arms: Exercise Maintenance; Exercise Maintenance + Relapse Prevention Booklets; Relapse Prevention Booklets + Contact; Contact Control. The Exercise Maintenance groups will be counseled on maintaining exercise in their home environment, while the other groups will be counseled on health issues not involving exercise or smoking. The "Forever Free" booklet series (Brandon, Collins, Juliano, & Lazev, 2000) will be distributed to participants in the Relapse Prevention groups. The primary outcome measure is continuous smoking abstinence. Secondary outcomes are exercise behaviour, and selected physiological and psychological variables. Results will assist researchers and health professionals develop and implement similar treatment interventions that are grounded in behaviour change theory.