Implementation, recruitment and baseline characteristics: A randomized trial of combined treatments for smoking cessation and weight control

Background Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. Methods This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management. Study participants were recruited via tobacco quitlines from August 5, 2013 to December 15, 2014. Results Statistical analysis on baseline data was conducted in 2015/2016. Among 5082 potentially eligible callers to a tobacco quitline, 2540 were randomized (50% of eligible). Compared with individuals eligible but not randomized, those randomized were significantly more likely to be female (65.7% vs 54.5%, p < 0.01), overweight or obese (76.3% vs 62.5%, p < 0.01), more confident in quitting (p < 0.01), more addicted (first cigarette within 5 min: 50.0% vs 44.4%, p < 0.01), and have a chronic disease (28.6% vs. 24.4%, p < 0.01). Randomized groups were not statistically significantly different on demographics, tobacco or weight variables. Two-thirds of participants were female and white with a mean age of 43. Conclusions Adding weight management interventions to tobacco cessation quitlines was feasible and acceptable to smokers. If successful for cessation and weight outcomes, a combined intervention may provide a treatment approach for addressing weight gain with smoking cessation through tobacco quitlines. Trial registration Clinicaltrials.gov NCT01867983.