Smoking CessationNCT03295643
Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
A study testing Mobile smoking cessation program and CO breath sensor device in people with Smoking Cessation, run by Jennifer Marler, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Mobile smoking cessation program and CO breath sensor device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Smoking Cessation
- Being tested
- Mobile smoking cessation program and CO breath sensor device
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile smoking cessation program and CO breath sensor deviceDevice
Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
| Study group | Role | What they receive |
|---|---|---|
| Mobile smoking cessation program | Other | Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. Receives: Device: Mobile smoking cessation program and CO breath sensor device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Secondary outcomes (10)
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".
Measured: 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.
Measured: 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.
Measured: 6 months
Number of Participants Who Completed the Program
The number of participants who completed the quit-smoking program.
Measured: 6 months
Quit Attempts
Number attempt to quit by participant
Measured: 6 months
Quit Rate 7-day Point Prevalence
Number of participant who have not smoked in last 7 days
Measured: 6 months
Quit Rate 30-day Point Prevalence
Number of participant who have not smoked in last 30 days
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start4 Oct 2017
- Primary completion31 Jul 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects experience same program
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Marler, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Jennifer Marler, MD, Pivot Health Technologies Inc.
- Investigators
- David Utley, MD, Principal investigator, Pivot Health Technologies, Inc (formerly Carrot Sense)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295643
- Sponsor's protocol ID
- C-601
- Status last verified
- Jun 2024
- First submitted
- 25 Sep 2017
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Marler JD, Fujii CA, Galanko JA, Balbierz DJ, Utley DS. Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study. J Med Internet Res. 2021 Feb 15;23(2):e25578. doi: 10.2196/25578.
PubMed 33482628Marler JD, Fujii CA, Utley DS, Tesfamariam LJ, Galanko JA, Patrick H. Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study. JMIR Mhealth Uhealth. 2019 Feb 4;7(2):e12609. doi: 10.2196/12609.
PubMed 30670372
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
- ClinicalTrials.gov ID
- NCT03295643
- Acronym / sponsor ID
- C-601
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Jennifer Marler, MDIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Posted 10 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects experience same program
| Arm | Type | Receives |
|---|---|---|
| Mobile smoking cessation program | Other | Device: Mobile smoking cessation program and CO breath sensor deviceMobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mobile smoking cessation program and CO breath sensor deviceMobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support. | Device | Mobile smoking cessation program |
Primary outcome
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.
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.
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.
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.
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.
10 secondary outcomes
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.
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.
Weeks of Active Engagement
Time frame: 6 months
Number of Participants Who Completed the Program
Time frame: 6 months
Quit Attempts
Time frame: 6 months
Quit Rate 7-day Point Prevalence
Time frame: 6 months
Quit Rate 30-day Point Prevalence
Time frame: 6 months
Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking
Time frame: 6 months
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33482628Marler JD, Fujii CA, Galanko JA, Balbierz DJ, Utley DS. Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study. J Med Internet Res. 2021 Feb 15;23(2):e25578. doi: 10.2196/25578.
- Derived from this study: PubMed 30670372Marler JD, Fujii CA, Utley DS, Tesfamariam LJ, Galanko JA, Patrick H. Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study. JMIR Mhealth Uhealth. 2019 Feb 4;7(2):e12609. doi: 10.2196/12609.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
David Utley, MD principal investigator
Pivot Health Technologies, Inc (formerly Carrot Sense)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile smoking cessation program and CO breath sensor device in people with Smoking Cessation, run by Jennifer Marler, MD at 1 site in United States.
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 8 inclusion and 0 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: finished, as of the sponsor's last update on 1 Jul 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295643, which also lists 2 linked publications.
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 1 Jul 2024.