An Interactive Smartphone Application to Motivate Smokers to Quit

NCT ID: NCT05799625

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 Type: EXPERIMENTAL

StepOne Smartphone Application

Intervention Type: 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.

Interventions

StepOne Smartphone Application

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Mir, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Ottawa Heart Institute

Locations

The University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20220696-01H

Identifier Type: -

Identifier Source: org_study_id