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OpenTrials
Completed

NCT Number: NCT03295643

Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months

Prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and a handheld breath sensor with coaching support over a six month period.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carrot Inc.

Redwood City, California, 94063, United States

About this study

This is a prospective, open label, single center clinical study enrolling 260 subjects in a mobile smoking cessation program using a smartphone app and handheld breath sensor with coaching support over a six month period. Measurements include user engagement and retention in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and quality of life over the study period, as well as user feedback on the program.

Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will then be emailed the registration link, which includes the electronic informed consent. After providing electronic informed consent, subjects register online and receive the hand held device which measures carbon monoxide (CO) which correlates to smoking behavior.

Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are completed, and subjects then self-train to use the breath sensor and smartphone app and allows viewing of CO sample values. The app also provides the user with ability to log cigarettes, view cigarette consumption trends, view instructional videos, complete educational activities and challenges, and engage with a coach.

Participants will experience the program in 5 phases and then complete the study at approximately six months after enrolling,activating device and app.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-65 years of age
  • English speaking
  • Smokes daily
  • Smokes 5 or more cigarettes per day
  • Owns and uses a smartphone (iPhone 5 and above, operating system iOS 9.0 and above, or, Android 4.4 and above, operating system Android 4.4 and above)
  • Employed at least 20 hours per week
  • Lives in the USA
  • Understands and willing to sign the Informed Consent Form

Treatment and study plan

Mobile smoking cessation program and CO breath sensor device

Device

Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.

Primary outcomes

  1. Number of Participants Who Completed the Explore Stage

    Time frame: Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.

  2. Number of Participants Who Completed the Build Stage

    Time frame: Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    For the number of participants who started the Build Stage, the proportion who completed the Build Stage.

  3. Number of Participants Who Completed the Mobilize Stage

    Time frame: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.

  4. Number of Participants Who Completed the Quit Stage

    Time frame: Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.

    For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.

  5. Number of Participants Who Completed the Secure Stage

    Time frame: Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.

    For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.

Secondary outcomes

  1. Readiness to Quit and Goals Related to Smoking Behavior

    Time frame: Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    Are you seriously thinking of quitting smoking? (stage of change) "Yes, within the next 30 days". "Yes, within the next 6 months". "No, not thinking of quitting".

  2. Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage

    Time frame: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis.

    Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.

  3. Weeks of Active Engagement

    Time frame: 6 months

    Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc)

    Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.

    Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.

  4. Number of Participants Who Completed the Program

    Time frame: 6 months

    The number of participants who completed the quit-smoking program.

  5. Quit Attempts

    Time frame: 6 months

    Number attempt to quit by participant

  6. Quit Rate 7-day Point Prevalence

    Time frame: 6 months

    Number of participant who have not smoked in last 7 days

  7. Quit Rate 30-day Point Prevalence

    Time frame: 6 months

    Number of participant who have not smoked in last 30 days

  8. Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking

    Time frame: 6 months

    the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking

  9. Confidence to Quit

    Time frame: Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    Confidence to quit. Estimate of means and standard errors based on linear mixed model.

    Participants were asked: "If you were to quit smoking right now, how successful would you be?" Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).

  10. Difficulty Maintaining Quit

    Time frame: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.

    Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model.

    Participants were asked: "If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?" Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).

Sponsors and collaborators

Lead sponsor

Jennifer Marler, MD

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 28, 2017
Registry last updated
Jul 1, 2024

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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