Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 24, 2020
Date Accepted: Mar 21, 2020
Effectiveness of a quit vaping text message program in promoting abstinence among young adult e-cigarette users: a randomized controlled trial protocol
ABSTRACT
Background:
Millions of young adults currently vape e-cigarettes, yet little research on vaping cessation interventions exists. Text messaging is a promising, scalable intervention strategy to deliver vaping cessation treatment.
Objective:
To evaluate the effectiveness of a text message quit vaping program (This is Quitting) in promoting abstinence from e-cigarettes among young adults; to examine changes in self-efficacy, perceived social norms, and social support for quitting as hypothesized mediators of program effectiveness; to examine whether treatment effectiveness is moderated by gender, race/ethnicity, or sexual minority status.
Methods:
N=2,600 young adult (ages 18-24 years) e-cigarette users in the U.S. will be recruited via online ads to participate in a research study. Participants will be randomized to This is Quitting or an assessment-only control condition. The primary outcome measure is 30-day vaping abstinence at 7-months post-enrollment.
Results:
Study recruitment began December 18, 2019 and is projected to be completed Spring 2020. The final 7-month follow-up is anticipated to be complete by Fall/Winter 2020. Because this is the first-ever evaluation of a quit vaping program, we were unable to draw on existing literature to determine the appropriate sample size. Therefore, we examined abstinence rates among an initial pilot sample of n=269 participants (This is Quitting: n=148; Control: n=121) who completed the 1-month follow-up to determine the final sample size. The 1-month response rate was 79.2%, with no difference between arms. Using intent to treat analyses that counted non-responders as still vaping, 30-day abstinence rates were 16.2% (24/148) among those randomized to This is Quitting and 8.3% (10/121) among those randomized to Control. A treatment difference of 16% vs. 8% is detectable with 80% power at 2-sided alpha=.05 with N=260/group (520 total). To detect treatment differences of this magnitude in a 20% subsample (e.g., Hispanic or sexual minority young adult e-cigarette users), we will enroll N=1,300/group (2,600 total).
Conclusions:
The scientific, clinical, and public health communities are desperate for cessation resources to address the vaping epidemic among young people. This study is the first-ever comparative effectiveness trial of an intervention to help young people quit vaping. It focuses on evaluating the effectiveness of a theory-grounded, empirically informed text message intervention among young adults. The study is fully powered to examine potentially important subgroup differences among young people who are more vulnerable to e-cigarette use. Though potentially more challenging from a research ethics and pragmatic standpoint, evaluating quit vaping intervention approaches in teens is an important area for future research. The data generated from this trial will establish a benchmark of effectiveness for other vaping cessation programs and begin to create a body of evidence focused on how best to help young people break free from e-cigarettes. Clinical Trial: ClinicalTrials.gov NCT04251273
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