Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial

Jennifer D Marler, Craig A Fujii, MacKenzie T Utley, Daniel J Balbierz, Joseph A Galanko, David S Utley, Jennifer D Marler, Craig A Fujii, MacKenzie T Utley, Daniel J Balbierz, Joseph A Galanko, David S Utley

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-based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment.

Objective: This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline-based smoking cessation smartphone app from the National Cancer Institute.

Methods: In this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings 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 carbon monoxide samples.

Results: Participants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean "total app openings through 12 weeks" (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot.

Conclusions: In this randomized controlled trial comparing the 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 mobile smoking cessation program.

Trial registration: ClinicalTrials.gov NCT04955639; https://ichgcp.net/clinical-trials-registry/NCT04955639.

Keywords: app; biofeedback; breath sensor; carbon monoxide; digital health; digital sensor; health promotion; mobile apps; mobile phone; smartphone; smoking cessation.

Conflict of interest statement

Conflicts of Interest: JDM, CAF, MTU, DJB, and DSU are current employees of Pivot Health Technologies Inc (Pivot), the developer of the Pivot smoking cessation program. They receive salary and stock options from Pivot. DSU is the president and chief executive officer of Pivot and an investor in the company. JAG is a paid statistical consultant.

©Jennifer D Marler, Craig A Fujii, MacKenzie T Utley, Daniel J Balbierz, Joseph A Galanko, David S Utley. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 24.11.2022.

Figures

Figure 1
Figure 1
Study participant CONSORT (Consolidated Standards of Reporting Trials) flow diagram. ICF: informed consent form; PTID: participant identification number.

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