An interventional study of Mobile smoking cessation program and CO breath sensor device in Smoking Cessation, sponsored by Jennifer Marler, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Jennifer Marler, MD · Not applicable, Interventional, and Other
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.
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.
Inclusion Criteria:
Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Device: 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.
Number of Participants Who Completed the Explore Stage
For the number of participants who started the Explore Stage, the proportion 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.
Number of Participants Who Completed the Build Stage
For the number of participants who started the Build Stage, the proportion 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.
Number of Participants Who Completed the Mobilize Stage
For the number of participants who started the Mobilize Stage, the proportion 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.
Number of Participants Who Completed the Quit Stage
For the number of participants who started the Quit Stage, the proportion 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.
Number of Participants Who Completed the Secure Stage
For the number of participants who started the Secure Stage, the proportion 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.
Readiness to Quit and Goals Related to Smoking Behavior
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".
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.
Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage
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.
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.
Weeks of Active Engagement
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.
Time frame: 6 months
Number of Participants Who Completed the Program
The number of participants who completed the quit-smoking program.
Time frame: 6 months
Quit Attempts
Number attempt to quit by participant
Time frame: 6 months
Quit Rate 7-day Point Prevalence
Number of participant who have not smoked in last 7 days
Time frame: 6 months
Quit Rate 30-day Point Prevalence
Number of participant who have not smoked in last 30 days
Time frame: 6 months
Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking
the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking
Time frame: 6 months
Confidence to Quit
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).
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
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).
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.
Online recruitment
| Milestone | Mobile Smoking Cessation Program |
|---|---|
| Started | 319 |
| Completed explore stage | 283 |
| Completed build stage | 183 |
| Completed mobilize stage | 139 |
| Completed quit stage | 131 |
| Completed secure stage | 126 |
| Completed | 272 |
| Not completed | 47 |
For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Completed the Explore Stage | 283 |
For the number of participants who started the Build Stage, the proportion who completed the Build Stage.
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Completed the Build Stage | 183 |
For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Completed the Mobilize Stage | 139 |
For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Completed the Quit Stage | 131 |
For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Completed the Secure Stage | 126 |
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".
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Baseline - Stage of Change — Yes, within the next 30 days | 94 |
| Baseline - Stage of Change — Yes, within the next 6 months | 176 |
| Baseline - Stage of Change — No, not thinking of quitting | 11 |
| End of Explore Stage - Stage of Change — Yes, within the next 30 days | 157 |
| End of Explore Stage - Stage of Change — Yes, within the next 6 months | 114 |
| End of Explore Stage - Stage of Change — No, not thinking of quitting | 10 |
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.
| percentage change in cpd | Mobile Smoking Cessation Program |
|---|---|
| Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage | -44.5 ± 3 |
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.
| weeks | All Participants |
|---|---|
| Weeks of Active Engagement | 12.4 ± 7.1 |
The number of participants who completed the quit-smoking program.
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Completed the Program | 272 |
Number attempt to quit by participant
| quit attempts | Mobile Smoking Cessation Program |
|---|---|
| Quit Attempts | 2.4 ± 3.1 |
Number of participant who have not smoked in last 7 days
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Quit Rate 7-day Point Prevalence | 102 |
Number of participant who have not smoked in last 30 days
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Quit Rate 30-day Point Prevalence | 88 |
the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking
| Participants | Mobile Smoking Cessation Program |
|---|---|
| Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking | 233 |
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).
| score on a scale | Mobile Smoking Cessation Program |
|---|---|
| Baseline Confidence to Quit | 4.2 ± 0.1443 |
| End of Explore Confidence to Quit | 5.9 ± 0.1508 |
| End of Build Confidence to Quit | 6.4 ± 0.1782 |
| End of Mobilize Confidence to Quit | 7.4 ± 0.1916 |
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).
| score on a scale | Mobile Smoking Cessation Program |
|---|---|
| Baseline difficulty maintaining quit | 3.1 ± 0.1449 |
| End of Explore difficulty maintaining quit | 4.9 ± 0.1531 |
| End of Build difficulty maintaining quit | 5.7 ± 0.1891 |
| End of Mobilize difficulty maintaining quit | 6.8 ± 0.2055 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Smoking Cessation Program | 0/319 (0%) | 0/319 (0%) | 0/319 (0%) |
| Age, Continuous(years) | Mobile Smoking Cessation Program |
|---|---|
| Mean | 42.8 ± 10.2 |
| Sex: Female, Male(Participants) | Mobile Smoking Cessation Program |
|---|---|
| Female | 184 |
| Male | 135 |
| Race/Ethnicity, Customized(Participants) | Mobile Smoking Cessation Program |
|---|---|
| Ethnicity — White | 264 |
| Ethnicity — African American | 22 |
| Ethnicity — Hispanic | 15 |
| Ethnicity — Asian | 5 |
| Ethnicity — American Indian or Alaska Native | 4 |
| Ethnicity — Native Hawaiian or other Pacific Islander | 2 |
| Ethnicity — Other | 7 |
| Region of Enrollment(participants) | Mobile Smoking Cessation Program |
|---|---|
| United States | 319 |
| Cigarettes smoked per day(Cigarettes per day) | Mobile Smoking Cessation Program |
|---|---|
| Mean | 17.7 ± 7.6 |
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Jennifer Marler, MD