Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Aug 4, 2022
Date Accepted: Oct 18, 2022
Date Submitted to PubMed: Oct 18, 2022
Outcomes of a Comprehensive Mobile Smoking Cessation Program with Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial
ABSTRACT
Background:
Cigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline (USCPG)-based digital smoking cessation program, comprises a personal carbon monoxide (CO) breath sensor, smartphone app, in-app text-based coaching, nicotine replacement therapy (NRT), and moderated online community. Promising Pivot cohort studies have established the foundation for comparative assessment.
Objective:
Determine the efficacy of Pivot vs. QuitGuide, a USCPG-based smoking cessation smartphone app from the National Cancer Institute.
Methods:
In this pilot randomized controlled trial (RCT), cigarette smokers in the US were recruited online and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free NRT. Data were self-reported via weekly online questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes towards quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app opens at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath CO samples.
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). Engagement via mean (SD) total app opens through 12 weeks (primary outcome): Pivot 148.3 (SD 199.5) vs. QuitGuide 83.9 (SD 65.6) (IRR,1.7; 95% CI, 1.3, 2.3; P<.001). Self-reported 7- and 30-day PPA and abstinence from all tobacco products were 6-7 percentage points higher in Pivot at 12 weeks [eg. 7-day PPA: Pivot 35.1% (33/94) vs.QuitGuide 27.7% (26/94), (ITT), (OR, 1.4; 95% CI, 0.8, 2.7; P=.28)], and about 10 percentage points higher at 26 weeks [eg. 7-day PPA: Pivot 36.2% (34/94) vs. 26.6% (25/94), (ITT), (OR, 1.7; 95% CI, 0.9, 3.2; P=.12)]. Biovalidated abstinence at 12 weeks: Pivot 28.7% (27/94) vs. QuitGuide 12.8% (12/94), (ITT), (OR, 2.8; 95% CI, 1.3, 6.1; P=.008). Biovalidated continuous abstinence at 26 weeks: Pivot 21.3% (20/94) vs. QuitGuide 9.6% (9/94), (ITT), (OR, 2.7; 95% CI, 1.1, 6.4; P=.03). Participant feedback, including ease of set-up, impact on smoking, and likelihood of program recommendation were favorable for Pivot.
Conclusions:
In this RCT comparing app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates, and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable digital smoking cessation program. Clinical Trial: Clinicaltrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639
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