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The use of e-cigarettes, or vaping, has increased exponentially in the past decade, particularly among youth. Emerging evidence indicates growing nicotine dependence among youth, revealing historically higher rates of dependence among current e-cigarette users compared to rates seen in earlier research. Despite the urgent need for youth vaping cessation interventions, there is limited knowledge about the process of vaping cessation, and few evidence-based interventions are available to young people seeking support. A notable literature review on vaping cessation resources for young people recommended technology-based interventions, such as smartphone apps and SMS text messaging services, as a promising area of vaping cessation research and intervention development.
The primary aim of our study is to determine the effectiveness of the
A 2-arm, single-blind, parallel randomized controlled trial will be conducted over 12 months. Study invitations will be sent to 600 youth (age: 16-18 years) and young adult (age: 19-29 years) e-cigarette users and randomized between an intervention arm, which will be using
Study recruitment began on March 4, 2022. Recruitment is anticipated to be completed in December 2022.
This protocol describes one of the first-ever randomized controlled trial studies to evaluate the effectiveness of an app-based intervention for supporting vaping cessation among youth aged 16 to 18 years and young adults aged 19 to 29 years. The findings from our trial will help increase our understanding of the process of vaping cessation among youth and provide evidence on the effectiveness of an app-based intervention in helping young people quit vaping. The trial results will also have implications in the development of current and future approaches to youth vaping cessation.
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The use of e-cigarettes, or vaping, has increased exponentially in the past decade, particularly among young people [
Despite the urgent need for youth vaping cessation interventions, there is limited knowledge about the process of vaping cessation, and few evidence-based interventions are available to young people seeking support [
Previous work in intervention research and development identified technology-based interventions as a promising area for promoting youth vaping cessation [
This protocol describes one of the first-ever randomized controlled trial (RCT) studies to evaluate the effectiveness of an app-based intervention for supporting vaping cessation among youth. The first-ever RCT of a vaping cessation intervention was designed to evaluate the effectiveness of an SMS text messaging program called
The primary aim of our study is to determine the effectiveness of the
A 2-arm, single-blind, parallel RCT will be conducted over 12 months. Study invitations will be sent to 600 youth and young adult e-cigarette users and randomized between an intervention arm, which will be using
The study is being conducted by the Ontario Tobacco Research Unit. Approval for the study protocol was obtained from the University of Toronto Office of Research Ethics (protocol number: 00038410).
Eligible participants are youth aged 16 to 29 years who live in Canada and have used nicotine e-cigarettes in the previous 30 days. Study participants will be recruited through the Vaping Dependence Cohort—an existing panel of youth enrolled in a prospective cohort study at the University of Toronto who provided consent for recontact in future studies at the Ontario Tobacco Research Unit. This panel is comprised of a broad sample of youth who self-reported current or past regular use of nicotine e-cigarettes. The use of nicotine e-cigarettes was assessed through a question that asked respondents if they had used e-cigarettes daily, in the past week, in the past month, in the past 3 months, or in the past year and if they had ever used an e-cigarette. This cohort was designed to balance recruitment by smoking status (
After eligibility screening, participants must provide informed consent to proceed with study enrollment. The web-based consent form contains information about the study, the
Each participant in the intervention and control arms will receive compensation (CAD $10 [US $7.46] electronic gift card) upon completion of the baseline survey questionnaire and each time they complete a follow-up survey throughout the course of the study.
Eligible participants will be identified from the Vaping Dependence Cohort. The
An earlier version of the
Like the original app for young adult smoking cessation,
The app also tracks cravings and vaping habits through a diary of vaping triggers that records when, where, and why vaping occurs. The app displays supportive messages and graphic images of encouragement in response to cravings and relapse, as well as direct links to evidence-based resources, such as quitlines. A visual representation of quitting progress over time is provided to users on the main page, and users have the ability to upload personalized pictures and verbal affirmations.
Based on an approach that is similar to the one used by Graham and colleagues [
A baseline questionnaire will be sent to both the intervention group and the control group, using a self-administered web-based survey. This will collect comprehensive data on the history and characteristics of vaping (eg, vaping dependence, use of e-cigarettes, and self-confidence to quit), self-perceived addiction to vaping, health status (including mental health, mood, and perceived stress), and current and previous history of the use of other substances (combustible cigarettes, marijuana, alcohol, hookahs, and other tobacco products). The baseline survey will also ask questions on environmental factors and cessation goals. Self-reported demographic data (age, sex, gender and sexual orientation, province and country of residence, race and ethnicity, education, and marital status) will also be collected in the baseline survey.
A follow-up survey will be sent to the control and intervention groups at 3, 6, 9, and 12 months. Responses to the follow-up survey will be used to analyze any significant changes in vaping habits and differences between groups. The follow-up survey questionnaire includes items on cross-contamination and the use of cessation methods.
The primary outcome variable will be self-reported 30-day PPA at 3 months, operationalized as not having vaped, even a puff, in the last 30 days. The secondary measures include the intention to quit smoking in the next 6 months (
The mHealth (mobile health) App Usability Questionnaire [
Qualitative interviews (n=25) will be conducted with participants in the intervention arm to gain insight on the usability and acceptability of the app. Interviews will be audio recorded and transcribed verbatim, and they will be analyzed in NVivo 12 (QSR International) by using a 6-step approach to thematic analysis, as proposed by Braun and Clarke [
Demographic and vaping characteristics (eg, vaping dependence, use of e-cigarettes, and self-confidence to quit) will be compared between groups at baseline. The intention-to-treat principle will be followed for statistical analyses, and all participants will be analyzed in the study arm to which they were randomized. Negative binomial regression with an identity function and robust SEs will be used to test between-group comparisons of the primary outcome variable—30-day PPA at follow-up. Multiple imputation via chained equations using the observed predictors of outcomes and the predictors of loss to follow-up will be performed to impute missing outcome data to correct for any potential bias caused by missing data. The imputation model will include age, sex and gender, education, marital status, province of residence, ethnicity, vaping dependence, self-confidence to quit, perceived stress, and the intervention group. The inverse of the adjusted risk difference will provide the number needed to treat.
The sample size of 600 (inclusive of both the control arm and the intervention arm) was selected to differentiate an effect size odds ratio of 1.60, assuming a base cessation rate of 5%, an α of .05, a power of 0.8, and a 75% (450/600) response rate.
For comparisons between secondary continuous outcomes and continuous outcomes, a linear regression with an identity function will be used. The secondary analysis of missing information will use the following two approaches to handle missingness: (1) imputation using the baseline observation carried forward or the classification of nonresponders as vapers in accordance with the Russell standard [
For the process measures (whether participants downloaded the intervention, the frequency of use, satisfaction, and helpfulness), a chi-square test of association will be performed for binary and categorical variables, and for the ordinal variables approximating a normal distribution, a two-tailed
Study recruitment began on March 4, 2022. Recruitment is anticipated to be completed in December 2022.
This is the first-ever RCT study to evaluate the effectiveness of a smartphone app for supporting youth vaping cessation. The primary aim of our study is to determine the effectiveness of the
The
It is important to note the potential limitations in some aspects of the design and implementation of our trial. First, most notably, our trial was designed to include an assessment-only control group. We recognize that other app-based interventions for health are typically compared against other active controls or even other app-based interventions. Our methodology was adopted from the methodology used in the only completed trial (at the time of writing) of a technology-based vaping cessation intervention [
The findings from our trial will help increase our understanding of the process of vaping cessation among youth and provide evidence on the effectiveness of an app-based intervention in helping young people quit vaping. The trial results will also have implications in the development of current and future approaches to youth vaping cessation.
mobile health
point prevalence abstinence
randomized controlled trial
Standard Protocol Items: Recommendations for Interventional Trials
None declared.