An Interactive Smartphone Application to Motivate Smokers to Quit

NCT05799625 | Active Not Recruiting

• 1 other identifier: 20220696-01H
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Behaviors; Smoking Cessation

Outcome Measures

Primary Outcomes (8)

• Self-reported readiness to quit

  Collected via survey

  Day 14

• Self-reported readiness to quit

  Collected via survey

  Day 45

• Self-reported readiness to quit

  Collected via survey

  Day 195

• Having made a quit attempt

  Collected via survey

  Day 14

• Having made a quit attempt

  Collected via survey

  Day 45

• Having made a quit attempt

  Collected via survey

  Day 195

• Rate of smoking cessation

  Biochemically verified using an expired carbon monoxide (CO) test

  Day 45 for participants who report smoking cessation

• Rate of smoking cessation

  Biochemically verified using an expired carbon monoxide (CO) test

  Day 195 for participants who report smoking cessation

Secondary Outcomes (6)

• Number of participants that made a quit attempt

  Day 14, 45, 195

• Change in smoking

  Day 14, 45, 195

• Point prevalence abstinence

  Day 14, 45, 195

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

  Day 14, 45, 195

• Use of cessation medication and/or e-cigarettes

  Day 14, 45, 195

Study Arms (2)

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.

Behavioral: StepOne Smartphone Application

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Hassan Mir, MD

  The University of Ottawa Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 5, 2023
• Study Start: March 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-09

Locations

CA (1)