Fit & quit: An efficacy trial of two behavioral post-cessation weight gain interventions

Abstract

While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7 kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Fit & Quit is a randomized, controlled efficacy trial that aims to examine the ability of a weight stability intervention and a weight loss intervention to reduce post-cessation weight gain. For this purpose, Fit & Quit will randomize participants to three conditions: (a) Small Changes, a weight gain prevention intervention; (b) Look AHEAD Intensive Lifestyle Intervention; and (c) a lower-intensity bibliotherapy intervention. All conditions will receive a highly efficacious behavioral (i.e., rate reduction skills, motivational interviewing) and pharmacological (i.e., varenicline) smoking cessation program. A total of 400 participants will be recruited and randomized to the three interventions. Participants will be recruited in waves, with 10 waves of approximately 40 participants per wave. The primary outcomes of this study include post-cessation weight gain and cessation status at 12-month follow-up. Fit & Quit will integrate and adapt the strongest evidence-based interventions available for weight management and smoking cessation. Fit & Quit is highly innovative in the areas of the target population, study design, and use of technology. For these reasons, we expect that Fit & Quit will make a significant public health contribution to curtailing the important cessation barrier of post-cessation weight gain.

A randomized controlled trial to reduce post-cessation weight gain

“…Potential participants completed screening questions to determine eligibility, including if they had smoked at least five cigarettes per day for the last year, were interested in quitting smoking in the next 30 days, and had access to a telephone and email for intervention delivery. Power analyses and full inclusion/exclusion criteria are described elsewhere [ 17 ]. Initial power analysis indicated recruitment of about 400 individuals.…”

“…Phone screening procedures and descriptions of subsequent visits are also described in detail elsewhere [ 17 ]. Briefly, potential participants who passed the phone screening were scheduled for a screening visit, where staff obtained informed consent.…”

“…Intervention procedures are described in detail elsewhere [ 17 ]. Briefly, the first group was the weight stability group (“Stability”), who received a Fitbit activity tracker and a step goal (i.e., increase by 2000–3000 steps per day over their baseline levels).…”

“…At each follow-up visit starting at two-month follow-up, participants who reported not smoking in the past 24 h were asked to take a cotinine test to biochemically verify their smoking abstinence. NicAlert™ was used prior to the COVID-19 pandemic [ 17 ]. At in-person visits, participants were asked to spit into a collection container, and a NicAlert™ test strip was used by staff to test cotinine levels.…”

Recruitment strategies for a post cessation weight management trial: A comparison of strategy cost-effectiveness and sample diversity

“…The trial for which participants were recruited was the Fit & Quit study; this study is a randomized three-arm clinical trial designed to evaluate the efficacy of a weight management intervention in reducing the likelihood of smoking cessation-related weight gain. Participants were randomized to one of three conditions: (1) a weight stability group, (2) weight loss intervention group, and (3) self-guided intervention group [ 15 ]. Following completion of the weight management intervention, participants across all three arms of the trial received 6 months of varenicline, a smoking cessation medication, in addition to a behavioral smoking cessation intervention.…”