Smoking CessationStepOneNCT05799625
An Interactive Smartphone Application to Motivate Smokers to Quit
A study testing StepOne Smartphone Application in people with Smoking Cessation and Smoking Behaviors, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking Behaviors
- What is being tested?
- StepOne Smartphone Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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.
Read the detailed description
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.
- Conditions
- Smoking Cessation, Smoking Behaviors
- Being tested
- StepOne Smartphone Application
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StepOne Smartphone ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No 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. |
| Intervention | Experimental | 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. Receives: Behavioral: StepOne Smartphone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported readiness to quit
Collected via survey
Measured: Day 14
Self-reported readiness to quit
Collected via survey
Measured: Day 45
Self-reported readiness to quit
Collected via survey
Measured: Day 195
Having made a quit attempt
Collected via survey
Measured: Day 14
Having made a quit attempt
Collected via survey
Measured: Day 45
Having made a quit attempt
Collected via survey
Measured: Day 195
Rate of smoking cessation
Biochemically verified using an expired carbon monoxide (CO) test
Measured: Day 45 for participants who report smoking cessation
Rate of smoking cessation
Biochemically verified using an expired carbon monoxide (CO) test
Measured: Day 195 for participants who report smoking cessation
Secondary outcomes (6)
Number of participants that made a quit attempt
Collected via survey
Measured: Day 14, 45, 195
Change in smoking
Collected via survey
Measured: Day 14, 45, 195
Point prevalence abstinence
Collected via survey
Measured: Day 14, 45, 195
Use of behavioural supports (e.g. counselling, quit lines)
Collected via survey
Measured: Day 14, 45, 195
Use of cessation medication and/or e-cigarettes
Collected via survey
Measured: Day 14, 45, 195
Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group
Collected via survey
Measured: Day 14, 45, 195
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start12 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Mir, MD, Principal investigator, The University of Ottawa Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799625
- Sponsor's protocol ID
- 20220696-01H
- Acronym
- StepOne
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive Smartphone Application to Motivate Smokers to Quit
- ClinicalTrials.gov ID
- NCT05799625
- Acronym / sponsor ID
- StepOne / 20220696-01H
- Conditions
- Smoking Cessation, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No 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. |
| Intervention | Experimental | Behavioral: StepOne Smartphone ApplicationEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StepOne Smartphone ApplicationThis 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. | Behavioural | Intervention |
Primary outcome
Self-reported readiness to quit
Time frame: Day 14
Collected via survey
Self-reported readiness to quit
Time frame: Day 45
Collected via survey
Self-reported readiness to quit
Time frame: Day 195
Collected via survey
Having made a quit attempt
Time frame: Day 14
Collected via survey
Having made a quit attempt
Time frame: Day 45
Collected via survey
Having made a quit attempt
Time frame: Day 195
Collected via survey
Rate of smoking cessation
Time frame: Day 45 for participants who report smoking cessation
Biochemically verified using an expired carbon monoxide (CO) test
Rate of smoking cessation
Time frame: Day 195 for participants who report smoking cessation
Biochemically verified using an expired carbon monoxide (CO) test
6 secondary outcomes
Number of participants that made a quit attempt
Time frame: Day 14, 45, 195
Change in smoking
Time frame: Day 14, 45, 195
Point prevalence abstinence
Time frame: Day 14, 45, 195
Use of behavioural supports (e.g. counselling, quit lines)
Time frame: Day 14, 45, 195
Use of cessation medication and/or e-cigarettes
Time frame: Day 14, 45, 195
Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group
Time frame: Day 14, 45, 195
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Mir, MD principal investigator
The University of Ottawa Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StepOne Smartphone Application in people with Smoking Cessation and Smoking Behaviors, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported readiness to quit (time frame: Day 14). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.