Importance: Most trials of behavioral or pharmaceutical interventions for people who smoke are limited to individuals reporting they are ready to quit smoking. Engaging individuals who initially report they are not yet ready to quit in brief, precessation, skills-building interventions (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) is challenging. Objective: To test an integrated behavioral plus NRT-sampling intervention using a gamification approach supported by mobile health. Design, Setting, and Participants: A multisite randomized clinical trial with site-level 1-to-1 allocation into 2 conditions was conducted in 4 US health care systems. A total of 433 individuals who were currently smoking and reported at enrollment that they were not ready to quit smoking were enrolled. The study was conducted from November 7, 2016, to July 31, 2020. Interventions: Take a Break (TAB) was a 3-week game experience and included 5 behavioral components (motivational messaging, challenge quizzes, brief abstinence goal setting, mobile health apps for cravings management, and reward points for participation) integrated with NRT sampling. TAB draws on social cognitive theory and game mechanics concepts to engage participants in health behavior change. The comparison included NRT sampling only. Main Outcomes and Measures: Time to first quit attempt (duration from TAB experience to primary outcome) and carbon monoxide level-verified smoking cessation at 6-month follow-up. All analyses used an intention-to-treat approach. Results: Of the 433 individuals included in the trial, 223 were women (52%); mean (SD) age was 54 (13) years. More than half (53% [112 of 213]) of the TAB participants completed 100% of the daily challenge quizzes in the first week, 73% (145 of 199) of participants who completed the goal-setting call set a brief abstinence goal (most frequently 1-2 days of abstinence from cigarettes), and 75% (159 of 213) of participants used the mobile health apps to manage nicotine cravings. Time to the first quit attempt was lower for the TAB vs comparison group (hazard ratio, 1.68; 95% CI, 1.09-2.60; P = .02). At the 6-month follow-up, 18% (28 of 160) of TAB participants and 10% (17 of 171) of the comparison (chi2 test, P = .045) participants obtained carbon monoxide level-verified smoking cessation (accounting for clustering of outcomes by site; odds ratio, 1.92; 95% CI, 1.01-3.68; P = .048). Conclusions and Relevance: The findings of this randomized clinical trial demonstrate that individuals not yet ready to quit smoking could be engaged in a brief abstinence game. Six months later, the TAB group had nearly double the rate of smoking cessation vs the NRT sampling comparison group. Integrating a skills-building game experience with brief NRT sampling can enhance long-term cessation among those not yet ready to quit smoking. Trial Registration: ClinicalTrials.gov Identifier: NCT02973425.

BACKGROUND: While smoking continues to be the most preventable cause of mortality in the United States, most current smokers remain not ready to quit at any given time. Engaging these 'motivation phase' smokers with brief experiences to build confidence and practice skills related to cessation could lead to sooner and more successful quit attempts. Increasingly available mobile technology and gamification can be used to provide smokers with accessible and engaging support. METHODS: We describe our protocol for conducting a randomized controlled trial evaluating Take a Break, an mHealth-based smoking pre-cessation challenge designed for smokers not ready to quit. Participants in the intervention receive 1) Motivational Messages, 2) text message Challenge Quizzes, 3) Goal-setting with tobacco treatment specialist, 4) Coping Mini-Games apps, and 5) Recognition and Rewards for participation during a 3-week challenge. Access to coping mini-games and motivational messaging continues for 6-months. Both intervention and comparison group participants receive brief Nicotine Replacement Therapy (NRT) sampling and daily smoking assessment text messages for three weeks. Primary outcomes include number of days abstinent during the challenge, change in patient-reported self-efficacy after the challenge, time to first quit attempt following the challenge, and 7-day point prevalent smoking cessation at six months. CONCLUSION: Take a Break is an innovative approach to engage those not prepared for a quit attempt. Take a Break provides motivation phase smokers with tools and a brief experience to prepare them for a quit attempt, filling a gap in tobacco cessation support and current research.

Objective: Digital health technologies most often reach only those more motivated to engage, particularly when preventive health is targeted. To test whether gamification could be used to engage low-motivation smokers, we conceptualized "Take a Break"-a 3-week technology-assisted challenge for smokers to compete in setting and achieving brief abstinence goals. Materials and Methods: In the feasibility study of the multi-technology Take a Break challenge, low-motivation smokers were given (1) daily motivational messages, (2) brief "challenge quizzes" related to smoking behaviors, (3) a telehealth call to personalize their abstinence goal for the challenge, (4) "coping minigames" to help manage cravings while attempting to achieve their brief abstinence goals, and (5) a leaderboard "webApp," providing comparative feedback on smokers' participation, and allowing for competition. Heterogeneity of engagement was tracked. Results: All 41 smokers initially reported that they were not actively quitting. Over half were employed less than full time (51%), completed less than a 4-year college education (76%), and experienced financial stress (54%). No smokers opted out of the motivational messages, and mean proportion of response to the challenge quizzes was 0.88 (SD = 0.19). Half of the smokers reported using the "coping minigames." Almost all set abstinence goals (78%), with over half lasting 1-2 days (51%); median = 1 day (IQR 1-7). Leaderboard points ranged widely. Conclusions: Rates of smoking in the developed world have declined, and those who remain smokers are complex and have lower motivation to quit. Using a game-inspired challenge, we achieved high levels of engagement from low-motivation smokers.