Smartphone App for Quitting Smoking

(StepOne Trial)

Recruiting in Ottawa (>99 mi)

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

382 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking.

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 data supports the effectiveness of the StepOne Smartphone Application treatment for quitting smoking?

Research shows that smartphone apps for smoking cessation can be promising tools, with some studies finding significant differences in smoking cessation outcomes in favor of app use. These apps often include features like self-tracking and setting a quit plan, which can help users quit smoking. ^{1 2 3 4 5}

How is the StepOne smartphone app treatment for quitting smoking different from other treatments?

The StepOne smartphone app for quitting smoking is unique because it leverages mobile technology to provide support and resources directly on a user's phone, making it highly accessible and convenient compared to traditional methods like counseling or medication. Unlike many existing apps, StepOne may focus on evidence-based strategies and user engagement features to enhance its effectiveness. ^{3 4 6 7 8}

Research Team

Hassan Mir, MD

Principal Investigator

The University of Ottawa Heart Institute

Eligibility Criteria

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

Living in Ontario, Canada

I am a smoker and do not plan to quit in the next 30 days.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. [2021]

2. England pubmed.ncbi.nlm.nih.gov

An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. [2022]

4. Canada 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. [2023]

5. Greece pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Apps for Smoking Cessation: A Review. [2020]

6. England pubmed.ncbi.nlm.nih.gov

QUALITY AND USE OF FREE SMOKING CESSATION APPS FOR SMARTPHONES. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Feature-level analysis of a novel smartphone application for smoking cessation. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Feature-Level Analysis of a Smoking Cessation Smartphone App Based on a Positive Psychology Approach: Prospective Observational Study. [2022]