Smoking BehaviorsGEMSNCT07459621
Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking
A study testing Experimental Intervention in people with Smoking Behaviors, run by Kaiser Permanente at 1 site in United States.
Trial summary
The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Experimental Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Current cigarette smoker who is ambivalent about smoking
- Not actively using any treatment to quit smoking
- Own and regularly use a smartphone
- State willingness to install and use their assigned app
- Willingness to receive study communications
- Smoke at least half a pack a day
- Meet geolocation requirements
Who cannot join
- A lifetime history of dementia or psychosis
- Visual impairments that prevent viewing phone content and they lack adaptive devices
- Report medical contra-indications for over-the-counter NRT use
- Due to the potential for bias introduced by fraudulent participants, other exclusions will be applied to deter fraudulent enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Anna C Edelmann, MScN, 866-459-2816, anna.c.edelmann@kpchr.org
Jennifer B McClure, PhD
About this study
Official title: Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial
The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes additional content designed for people who aren't ready to quit smoking.
The investigators hypothesize that people who receive the experimental intervention will be more likely to request additional stop-smoking resources offered through the intervention and report smoking abstinence after 6 months.
The investigators also hypothesize people assigned to the experimental app will have better app engagement and be more likely to report positive changes in their smoking behavior and use of other evidence-based stop smoking treatments that are publicly available.
- Conditions
- Smoking Behaviors
- Being tested
- Control Intervention, Experimental Intervention
- Keywords
- Smoking, mHealth, motivation, ambivalent smokers
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control InterventionBehavioural
GEMS mHealth app including standard, best-practice information and advice to support quitting smoking, in-app motivational support, and access to publicly-available, evidence-based stop smoking resources and treatment. App can be used ad-lib during the study duration.
Experimental InterventionBehavioural
GEMS mHealth app including same standard care, best-practice information and advice for quitting smoking and in-app motivational support as in the control arm, plus additional content designed to help users clarify their values, build motivation for change, and learn skills necessary to quit smoking. App can be used ad-lib during the study duration.
| Study group | Role | What they receive |
|---|---|---|
| Control Intervention | Active comparator | Control participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. Receives: Behavioral: Control Intervention |
| Experimental | Experimental | Experimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. Receives: Behavioral: Experimental Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence-based treatment request
Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app.
Measured: 6-months post-randomization
7-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 7 days.
Measured: 6-months post-randomization
Secondary outcomes (9)
7-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 7 days. (Co-primary outcome assessed at earlier time point)
Measured: 3-months post-randomization
30-day Point Prevalence Abstinence (PPA) [Self-report]
Self-report of no smoking, even a puff, in the past 30 days.
Measured: 3- and 6-months post-randomization
7-day Point Prevalence Abstinence (PPA) [Confirmed]
Biochemically confirmed self-report of no smoking, even a puff, in the past 7 days.
Measured: 6-months post-randomization
Evidence-based treatment request
Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app. (Co-primary outcome assessed at earlier time point).
Measured: 3-months post-randomization
Use of any cessation treatment
Self-reported use of any evidence-based smoking cessation treatment (FDA-approved medication or behavioral interventions) since enrollment, whether provided by study or not.
Measured: 3- and 6-months post-randomization
Successful 24-hour quit attempt
Self-reported presence of an intentional quit attempt lasting at least 24 hrs (Y/N) since randomization.
Measured: By 3-months and 6-months post-randomization
Any quit attempt
Self-reported presence of any intentional quit attempt, regardless of duration (Y/N) since study enrollment.
Measured: By 3-months and 6-months post-randomization
Change in cigarettes per day
Change from baseline in number of cigarettes smoked per day at follow-up, calculated both as a continuous measure and as a dichotomous measure (Y/N >=50% reduction from baseline).
Measured: Baseline to each of 3-months and 6-months post-randomization
Tobacco and nicotine abstinence
Self-report of abstinence from all non-therapeutic nicotine and tobacco products.
Measured: 3- and 6-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start7 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fred Hutchinson Cancer Center, University of California, Davis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459621
- Sponsor's protocol ID
- 2171564
- Other IDs
- R01CA293229
- Acronym
- GEMS
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data and accompanying data dictionaries will be stored for future sharing as anonymized data sets in a data repository per NIH data sharing requirements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07459621
- Acronym / sponsor ID
- GEMS / 2171564
- Conditions
- Smoking Behaviors
- Keywords
- Smoking, mHealth, motivation, ambivalent smokers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fred Hutchinson Cancer Center, University of California, Davis
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes additional content designed for people who aren't ready to quit smoking.
The investigators hypothesize that people who receive the experimental intervention will be more likely to request additional stop-smoking resources offered through the intervention and report smoking abstinence after 6 months.
The investigators also hypothesize people assigned to the experimental app will have better app engagement and be more likely to report positive changes in their smoking behavior and use of other evidence-based stop smoking treatments that are publicly available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Intervention | Active comparator | Behavioral: Control InterventionControl participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. |
| Experimental | Experimental | Behavioral: Experimental InterventionExperimental participants receive a study-branded mHealth app and access to other publicly-available, evidence-based smoking cessation interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age and older
- Current cigarette smoker who is ambivalent about smoking
- Not actively using any treatment to quit smoking
- Own and regularly use a smartphone
- State willingness to install and use their assigned app
Key exclusion criteria (4 listed)
- A lifetime history of dementia or psychosis
- Visual impairments that prevent viewing phone content and they lack adaptive devices
- Report medical contra-indications for over-the-counter NRT use
- Due to the potential for bias introduced by fraudulent participants, other exclusions will be applied to deter fraudulent enrollment.
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 |
|---|---|---|
| Control InterventionGEMS mHealth app including standard, best-practice information and advice to support quitting smoking, in-app motivational support, and access to publicly-available, evidence-based stop smoking resources and treatment. App can be used ad-lib during the study duration. | Behavioural | Control Intervention |
| Experimental InterventionGEMS mHealth app including same standard care, best-practice information and advice for quitting smoking and in-app motivational support as in the control arm, plus additional content designed to help users clarify their values, build motivation for change, and learn skills necessary to quit smoking. App can be used ad-lib during the study duration. | Behavioural | Experimental |
Primary outcome
Evidence-based treatment request
Time frame: 6-months post-randomization
Composite indicator of (1) Earning the ability to request free nicotine replacement therapy (NRT) through sufficient app participation and requesting NRT and/or (2) accessing free quitline services through the app.
7-day Point Prevalence Abstinence (PPA) [Self-report]
Time frame: 6-months post-randomization
Self-report of no smoking, even a puff, in the past 7 days.
9 secondary outcomes
7-day Point Prevalence Abstinence (PPA) [Self-report]
Time frame: 3-months post-randomization
30-day Point Prevalence Abstinence (PPA) [Self-report]
Time frame: 3- and 6-months post-randomization
7-day Point Prevalence Abstinence (PPA) [Confirmed]
Time frame: 6-months post-randomization
Evidence-based treatment request
Time frame: 3-months post-randomization
Use of any cessation treatment
Time frame: 3- and 6-months post-randomization
Successful 24-hour quit attempt
Time frame: By 3-months and 6-months post-randomization
Any quit attempt
Time frame: By 3-months and 6-months post-randomization
Change in cigarettes per day
Time frame: Baseline to each of 3-months and 6-months post-randomization
Tobacco and nicotine abstinence
Time frame: 3- and 6-months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Deidentified data and accompanying data dictionaries will be stored for future sharing as anonymized data sets in a data repository per NIH data sharing requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Intervention in people with Smoking Behaviors, run by Kaiser Permanente 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 4 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer B McClure, PhD (503-335-2400, jennifer.b.mcclure@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence-based treatment request (time frame: 6-months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.