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OpenTrials
Active, Not Recruiting

NCT Number: NCT05799625

An Interactive Smartphone Application to Motivate Smokers to Quit

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

About this study

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. The intervention has been designed based by a team of scientist, taking principles of change behaviour into consideration. The application incorporates daily reminders, gamification, and models of habit formation to engage users. It will support participants to reflect on their smoking in a holistic manner through questions and activities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older.
  • Living in Ontario, Canada.
  • Current smoker who indicates they are not interested in quitting within the next 30-days.
  • Have access to and regularly use a smartphone with internet access.
  • Read, write, speaks English or French.
  • Available and willing to participate in follow-up assessments over the next 6 months.
  • Able to provide consent.

Exclusion criteria

  • Planning on quitting smoking within the next 30-days.
  • Cognitively impaired or experiencing acute psychiatric illness that would alter their ability to participate.
  • Institutionalized at a retirement home, nursing home or long-term care facility.
  • Has morbid illness which will prevent completion of 6-month follow-up (e.g., receiving palliative care).
  • Participating in another smoking cessation program

Treatment and study plan

StepOne Smartphone Application

Behavioral

This smartphone application provides a 14-day program that delivers the core components of smoking cessation (i.e., counseling, education) and takes advantage of pandemic-accelerated acceptance of virtual care, videoconferencing, remote monitoring, and social networking. The program seeks to move participants from the pre-action stage (not interested in quitting) to the action stage (intention to quit) and incorporates daily reminders, gamification, and models of habit formation to engage users.

Primary outcomes

  1. Self-reported readiness to quit

    Time frame: Day 14

    Collected via survey

  2. Self-reported readiness to quit

    Time frame: Day 45

    Collected via survey

  3. Self-reported readiness to quit

    Time frame: Day 195

    Collected via survey

  4. Having made a quit attempt

    Time frame: Day 14

    Collected via survey

  5. Having made a quit attempt

    Time frame: Day 45

    Collected via survey

  6. Having made a quit attempt

    Time frame: Day 195

    Collected via survey

  7. Rate of smoking cessation

    Time frame: Day 45 for participants who report smoking cessation

    Biochemically verified using an expired carbon monoxide (CO) test

  8. Rate of smoking cessation

    Time frame: Day 195 for participants who report smoking cessation

    Biochemically verified using an expired carbon monoxide (CO) test

Secondary outcomes

  1. Number of participants that made a quit attempt

    Time frame: Day 14, 45, 195

    Collected via survey

  2. Change in smoking

    Time frame: Day 14, 45, 195

    Collected via survey

  3. Point prevalence abstinence

    Time frame: Day 14, 45, 195

    Collected via survey

  4. Use of behavioural supports (e.g. counselling, quit lines)

    Time frame: Day 14, 45, 195

    Collected via survey

  5. Use of cessation medication and/or e-cigarettes

    Time frame: Day 14, 45, 195

    Collected via survey

  6. Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group

    Time frame: Day 14, 45, 195

    Collected via survey

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Acronym: StepOne

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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