Death rates for lung cancer have now surpassed breast cancer as the leading cause of cancer deaths in women, reflecting the increase in smoking among women in recent decades. Survey and experimental data suggest that women have greater difficulty quitting cigarettes than men. Various social, psychological, and behavioral explanations of this problem have been suggested but one of the most prevalent differences between male and female smokers is the greater fear of post-cessation weight gain among women. The mechanisms accounting for post-cessation weight gain are not fully known but knowledge of the problem is sufficient to propose strategies to limit the impact of this common sequelae of cessation. A Randomized Clinical Trial (RCT) involving 360 female smokers with an expressed concern about post-cessation weight gain will test behavioral and pharmacological weight gain prevention strategies. Weight control strategies focused on weight maintenance and nicotine replacement via gum will address both behavioral and physiological aspects of this common problem. Both treatments will focus on reducing fear of large weight gains and acceptance of small but common post-cessation weight gains. All randomized subjects will receive the American Lung Association (ALA) Freedom From Smoking (FFS) Clinic Program (seven-session smoking cessation program). In a 2X2 RCT design, subjects will be randomized to receive (a) either a multi-component Behavioral Self-Study Treatment (BSST) for weight gain prevention or a small ALA pamphlet on the topic, and (b) either Nicorette (nicotine containing) gum or no gum. It is predicted that the BSST and Nicorette gum conditions with both enhance chemically validated abstinence rates at the 12-month follow-up with rates varying from 50% in the combined condition down to 15% in the ALA FFS only group. The design will have sufficient power to detect predicted main and interactive effects using log-linear analyses of quit rates, multiple-logit survival analyses of relapse rates, and analysis of covariance of continuous dependent variables. The study is designed to enhance generalizability. If either Nicorette gum or the BSST enhance the sustained quit rate of the nationally available ALA FFS Clinic program when used with female smokers concerned about post-cessation weight gain, the ability to attract females to an effective smoking cessation option will be significantly enhanced.
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