| Summary: | Abstract Background Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting smoking, but few smokers use them, and they often use them for too short a time and at an insufficient dose. It is therefore important to increase access to support for smoking cessation and compliance with nicotine therapy. The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants. Methods Trial design: this is a two-arm, parallel-group, superiority, individually randomized, “placebo” controlled trial in 5200 smokers, with follow up after 1 week, 1 month and 6 months. The participants are adult daily smokers (N = 5200) enrolled on the Internet, living in France or Switzerland. The intervention is the Stop-tabac fully-automated app for smartphones, which was launched in 2012 and continuously improved thereafter. It includes fact sheets; calculators of cigarettes not smoked, money saved, and years of life gained; an interactive “coach” that provides automated, individually tailored counseling messages based on the user’s personal profile, sent regularly for 6 months; immediate feedback during episodes of craving and tobacco withdrawal symptoms; a discussion forum (“The Tribe”) where participants provide and receive social support; a quiz that informs users in a playful way; and a module on nicotine therapy that includes personalized feedback and follow up. The outcome is self-reported smoking cessation after 6 months (no puff of tobacco in the past 4 weeks), and after 1 week and 1 month (no puff in the past 7 days). Participants will be randomized automatically based on a list of random numbers. Participants, assistants in charge of collecting follow-up data and data analysts will be blinded to allocation. Funding is provided by the Swiss National Science Foundation, CHF 194,942 (EUR 182,200, USD 200,700), grant 32003_179369. JFE’s salary is paid by the University of Geneva, YK’s salary is paid by the Lausanne University Hospitals. Discussion There is little evidence from randomized trials of the impact of health apps in general and of smoking cessation apps in particular. This study will fill this gap. Trial registration ISRCTN Registry: ISRCTN11318024 . Registered on 17 May 2018.
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