Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Apr 13, 2023
Date Accepted: Aug 15, 2023
Date Submitted to PubMed: Aug 16, 2023
Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program with Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial
ABSTRACT
Background:
Increased smartphone ownership has been accompanied by the development of mobile smoking cessation programs. While the related body of evidence, through conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability.
Objective:
The primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program: Pivot (intervention) versus QuitGuide (control). Secondary aims included comparison of other smoking-related behaviors and outcomes, participant feedback, and exploratory analyses of baseline factors associated with smoking cessation.
Methods:
In this remote pilot RCT, cigarette smokers in the U.S. were recruited online. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via online questionnaire, with videoconference biovalidation in participants who reported 7-day point prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-efficacy Questionnaire (SASEQ), NRT use and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products and continuous abstinence. PPA and continuous abstinence were biovalidated via witnessed breath carbon monoxide (CO) samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation.
Results:
Participants comprised 188 smokers (94 Pivot, 94 QuitGuide): mean (SD) age 46.4 (9.2) years, 104 women (55.3%), 128 White individuals (68.1%), mean (SD) CPD 17.6 (9.0). Several cessation rates were higher in Pivot (intention to treat, ITT): self-reported continuous abstinence: 20% (19/94) versus QuitGuide 9% (8/94) (P=.03), biochemically confirmed abstinence: 31% (29/94) versus QuitGuide 18% (17/94) (P=.04), and biochemically confirmed continuous abstinence: 19% (18/94) versus QuitGuide 9% (8/94) (P=.046). More Pivot participants (99%, 93/94 versus 85%, 80/94 in QuitGuide, P<.001) placed more NRT orders: mean (SD) 3.3 (2.0) versus QuitGuide 1.8 (1.6) (P<.001). Pivot participants had increased self-efficacy via SASEQ: mean (SD) 3.2 (7.8) point increase (P<.001) versus 1.0 (8.5) in QuitGuide (P=.26). QuitGuide participants made more mean (SD) quit attempts: Pivot 7.0 (6.3) versus QuitGuide 9.5 (7.5) (P=.01). Among those not achieving abstinence, QuitGuide participants reported greater CPD reduction: Pivot, -34.6% (SD 35.5%) versus QuitGuide, −46.1% (SD 32.3%) (P=.04). Among participants reporting abstinence, 90% (Pivot 35/39; QuitGuide 26/29) indicated their cessation program helped them quit.
Conclusions:
In this pilot RCT comparing the Pivot and QuitGuide mobile smoking cessation programs, Pivot was more effective, with higher cessation rates durable through 52 weeks. Clinical Trial: Clinicaltrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639
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