Smartphone App for Quitting Smoking

(StepOne Trial)

Overseen By Zain Saleem

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Acute psychiatric illness, Morbid illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can assist smokers in preparing to quit, attempting to quit, and successfully quitting smoking. Participants will either use the StepOne app, which provides daily activities and reminders for two weeks, or receive a brochure with information on a smoking cessation program. The trial seeks smokers living in Ontario who regularly use a smartphone and do not plan to quit in the next 30 days.

As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could lead to new tools for smoking cessation.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the StepOne Smartphone Application is safe for users?

Research shows that using apps to quit smoking is generally safe. Studies on similar smartphone apps have found that people use them without problems. These apps usually provide helpful information, reminders, and activities to support quitting smoking. Users have not reported any serious side effects or harm from these apps. The StepOne app in this trial works similarly, offering interactive content and daily updates. So far, no evidence indicates any major safety issues with using these apps to help quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the StepOne smartphone application because it offers a unique, interactive approach to quitting smoking. Unlike traditional methods that rely on brochures or in-person support, this app uses gamification and models of habit formation to engage users actively. It delivers daily content and reminders to help smokers stay on track, allowing users to interact with the program at their convenience. This new delivery method could potentially increase user engagement and success rates by making the quitting process more personalized and accessible.

What evidence suggests that the StepOne smartphone application is effective for quitting smoking?

Research has shown that mobile apps can help people quit smoking. In this trial, participants in the intervention group will use the StepOne smartphone application, which includes interactive educational material, daily reminders, gamification, and models of habit formation. Studies have found that people using smoking cessation apps are more likely to quit than those following traditional methods, with one study reporting a 67% higher success rate. Another study found an average quit rate of 33.9% across several trials. Additionally, people using apps like iCanQuit were almost twice as likely to stop smoking compared to other methods, with benefits lasting up to a year. Overall, app-based programs offer a promising way to help people quit smoking. ^{3 6 7 8 9}

Who Is on the Research Team?

Hassan Mir, MD

Principal Investigator

The University of Ottawa Heart Institute

Are You a Good Fit for This Trial?

This trial is for smokers in Ontario, Canada who are over 18, can use a smartphone with internet, and speak English or French. They must not plan to quit smoking within the next month but be willing to follow up for 6 months. Those in long-term care or with illnesses preventing full participation are excluded.

Inclusion Criteria

Able to provide consent

Reads, writes, and speaks English or French

Living in Ontario, Canada

Exclusion Criteria

Institutionalized at a retirement home, nursing home, or long-term care facility

Planning on quitting smoking within the next 30 days

I am not experiencing any severe mental health issues that would prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants in the intervention group download and use the StepOne smartphone application for a 14-day program, engaging with daily reminders, gamification, and habit formation models.

2 weeks

Daily interaction with the app

Follow-up

Participants are monitored for smoking cessation, readiness to quit, and use of cessation aids through surveys at multiple time points.

28 weeks

Surveys at Day 14, 45, and 195

What Are the Treatments Tested in This Trial?

Interventions

• StepOne Smartphone Application

Trial Overview The trial tests the StepOne Smartphone Application's effectiveness in motivating smokers to prepare to quit, attempt quitting, and succeed in quitting. Participants will be randomly assigned to use the app and their progress will be monitored without knowing which group they're in.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Eligible smokers randomized to the intervention group will be asked to download the StepOne smartphone application onto their smartphone via the Apple Store or Google Play Store. They will be provided with a unique ID and unique code, which will enable them to log into the StepOne smartphone application to begin the 14-day program. Users will interact with the application in the morning and evening; the exact time of the engagement is selected by the participant and ideally at a time that maximizes the likelihood of engaging with the activity. The application incorporates interactive educational material, daily reminders, gamification, and models of habit formation to engage users. As with any other smartphone application, users can turn off notifications if they choose to do so. New content and activities will be shared daily.

Group II: Usual Care Active Control 1 Intervention

Eligible smokers randomized to usual care will receive an educational brochure for the University of Ottawa Heart Institute's Ottawa Model for Smoking Cessation (OMSC) Community Program. The brochure will include information about the OMSC Community Program and how to register for it to receive assistance to quit smoking.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

A smartphone app designed for smoking cessation effectively assessed real-time risk for smoking lapses and provided tailored messages, leading to greater reductions in smoking urges, stress, and cigarette availability among participants (N=59) over a 3-week period.

Messages specifically tailored to individual triggers, such as smoking urges and stress, were more effective in reducing those triggers compared to generic messages, suggesting that personalized interventions can enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. Hébert, ET., Stevens, EM., Frank, SG., et al.[2022]

A study of 252 smoking cessation apps for iPhone and 148 for Android revealed that popular apps generally have low adherence to U.S. Public Health Service guidelines, scoring an average of only 12.9 out of 42 on the Adherence Index.

None of the apps recommended calling a quitline, and only 4.1% suggested using approved medications, indicating a significant gap in evidence-based support for users trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. Abroms, LC., Lee Westmaas, J., Bontemps-Jones, J., et al.[2022]

A study involving 181 participants found that most users rated the smoking cessation app QuitPal-m as very helpful, but daily usage declined over time, indicating a need for ongoing support to maintain engagement.

The effectiveness of the app was enhanced by supportive accountability from cessation counselors, particularly for smokers with low motivation to quit, highlighting the importance of addressing both personal barriers and technical issues to improve app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. Lepore, SJ., Collins, BN., Killam, HW., et al.[2023]

Smartphone applications for smoking cessation have been shown to increase quit rates among smokers, particularly when users engage with features like audiovisual content, quit plans, and progress tracking.

While these apps can help reduce relapse rates, the effectiveness varies based on how well users adhere to the app's features, indicating that user engagement is crucial for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Apps for Smoking Cessation: A Review. Regmi, K., Kassim, N., Ahmad, N., et al.[2020]

A study analyzing the first fifty free smoking cessation apps on Android and iOS found that only 15% involved Nicotine Dependence Treatment Providers (NDTP), indicating a lack of evidence-based support in app development.

Despite over half of the apps being downloaded more than 500,000 times and receiving average ratings around 3.8 out of 5, most apps only provided basic tracking features and limited motivational tips, suggesting a need for more innovative and effective tools for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUALITY AND USE OF FREE SMOKING CESSATION APPS FOR SMARTPHONES. Regmi, D., Tobutt, C., Shaban, S.[2019]

In a pilot trial involving 76 participants using the 'SmartQuit' smoking cessation app, the most popular features were related to cognitive behavioral therapy (CBT), such as the quit plan and tracking progress.

Only two features, viewing the quit plan and tracking the practice of letting urges pass, were significantly associated with successful quitting, indicating that not all popular features effectively contribute to smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feature-level analysis of a novel smartphone application for smoking cessation. Heffner, JL., Vilardaga, R., Mercer, LD., et al.[2018]

A study involving 100 nondaily smokers using the Smiling Instead of Smoking app for 49 days showed that greater app usage was linked to higher rates of smoking cessation, with 40% abstinence at the end of treatment and 56% at the 6-month follow-up.

Engagement with positive psychology content in the app was a significant predictor of smoking abstinence, suggesting that such features may enhance user engagement and support long-term cessation efforts more effectively than traditional smoking cessation content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feature-Level Analysis of a Smoking Cessation Smartphone App Based on a Positive Psychology Approach: Prospective Observational Study. Hoepper, BB., Siegel, KR., Carlon, HA., et al.[2022]

Mobile health (mHealth) apps for smoking cessation, both as standalone general apps (GSC-Apps) and in combination with face-to-face interventions (FFSC-Apps), show promise in improving smoking cessation outcomes, with some studies indicating significant benefits from their use.

Despite the potential of these apps to reach a wide audience due to their accessibility, further high-quality research is necessary to fully understand their effectiveness and optimize their features for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. Barroso-Hurtado, M., Suárez-Castro, D., Martínez-Vispo, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7682489/

Effectiveness of mobile applications to quit smoking Results showed a beneficial effect compared to usual clinical practice (RR=1.67; 95% CI: 1.46–1.90). Other research studies have found similar results. On the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787327/

Effectiveness of the QuitSure Smartphone App for Smoking ... The study reported a mean abstinence rate of 33.9% of 7 single-arm trials. Additionally, another review of smoking cessation apps, which ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2770816

Efficacy of Smartphone Applications for Smoking Cessation For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants were 1.49 times more likely to quit smoking compared with ...

4. jmir.org jmir.org/2023/1/e43242/

The Effectiveness of Smartphone App–Based Interventions ... Quitting smoking reduces the risk of all-cause mortality by 11%-34%. Smartphone app–based smoking cessation (SASC) interventions have been ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460322001435

Efficacy of smartphone applications for smoking cessation ... At 12-months, iCanQuit participants had nearly double the odds of smoking cessation compared to QuitGuide (complete-case 30-day PPA = 24% vs. 15%; OR = 1.87 95% ...

6. allclinicaltrials.com allclinicaltrials.com/study/NCT05799625

An Interactive Smartphone Application to Motivate Smokers ... Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10510452/

Mobile Phone–Based Interventions for Smoking Cessation ... Our findings suggest that SMS text messaging interventions could be effective for smoking cessation among young individuals, whereas the evidence for app-based ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7268412/

The Stop-Tabac smartphone application for smoking ... The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is ...

9. bmjopen.bmj.com bmjopen.bmj.com/content/9/12/e031204

Design, development and randomised controlled trial of a ... We will develop a smartphone application 'QinTB' to help TB patients quit smoking, and we will evaluate the clinical efficacy of this application by using a ...