Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial.

INTRODUCTION: Tobacco smoking is the leading cause of preventable disease, disability, and premature death in the United States. Recent advances have led to two efficacious mobile health (mHealth) treatments for smoking cessation: iCanQuit, an Acceptance and Commitment Therapy-based behavioral treatment promoting cessation through accepting triggers and committing to values; and Motiv8, a contingency management intervention promoting smoking cessation with financial incentives via biochemically verified abstinence. This study will evaluate the comparative effectiveness of the Florida Quitline, iCanQuit alone, and iCanQuit+Motiv8 in a pragmatic trial among patients who smoke in underserved primary care settings. METHODS: The study will be an individually-randomized controlled trial with three arms (Florida Quitline, iCanQuit alone, iCanQuit+Motiv8 combined) conducted in multiple primary care practices affiliated with the OneFlorida+ Clinical Research Consortium. Adult patients who smoke will be randomized to one of the 3 study arms (n = 444/arm), stratified by healthcare setting (academic vs. community). The primary outcome will be 7-day point prevalence smoking abstinence at 6 months post-randomization. Secondary outcomes will be 12-month smoking abstinence, patient satisfaction with the interventions, and changes in patient quality of life and self-efficacy. The study will also assess how and for whom the interventions help sub-group patients in achieving smoking abstinence by measuring theory-derived factors that mediate smoking outcome-specific baseline moderators. CONCLUSIONS: Results from this study will provide evidence for the comparative effectiveness of mHealth smoking cessation interventions in healthcare settings. Use of mHealth interventions can make smoking cessation resources more equitably accessible and have far-reaching impact on community and population health. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05415761, Registered 13 June 2022.

Mixed methods evaluation of vaping and tobacco product use prevention interventions among youth in the Florida 4-H program.

INTRODUCTION: Novel prevention programs are developed to address the increase in e-cigarette use (vaping) among children. However, it remains paramount to test their feasibility in rural settings. This pilot study implemented and evaluated the feasibility and outcomes of two innovative programs, CATCH My Breath and smokeSCREEN, among youth in rural settings in Florida. METHODS: We conducted four focus groups with youth aged 11-17 recruited from 4-H rural clubs in Florida. In a subsequent randomized trial, we recruited 82 youth participants and assigned them to one of three arms: CATCH My Breath, smokeSCREEN, or control. CATCH My Breath and smokeSCREEN participants attended online group intervention sessions while the control group received educational material. Pre- and post-surveys were administered to all participants to assess knowledge, susceptibility, perceived positive outcomes and risk perceptions related to tobacco and e-cigarette use. Other feasibility parameters were also assessed. RESULTS: Focus group discussions provided insights about feasibility and informed the implementation of both interventions in terms of delivery format, scheduling of sessions and incentives. After the intervention, CATCH My Breath participants significantly improved their general tobacco-related knowledge (post-pre = 16.21-12.92 = 3.3, p <.01) and risk perceptions towards other flavored tobacco products (post-pre = 19.29-17.71 = 1.6, p <.05). smokeSCREEN participants significantly improved their general tobacco knowledge (post-pre = 18.77-13.77 = 5.0, p <.01), knowledge about e-cigarettes (post-pre = 9.08-6.31 = 2.8, p <.01) and risk perception towards e-cigarettes (post-pre = 24.69-21.92 = 2.8, p <.05). CONCLUSIONS: This study demonstrated feasibility of delivering the interventions via participant engagement, participants' willingness to be randomized, assessment of outcome measures, and exploration of different recruitment methods. Despite the potential positive influence of CATCH My Breath and smokeSCREEN on youth participants, further evaluation with larger samples is needed.