Current SmokerMARSNCT04376489
Project MARS: Mobile-Assistance for Regulating Smoking
A study testing Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available), Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available) and Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available) in people with Current Smoker and Tobacco Smoking, run by University of Utah at 1 site in United States.
Trial summary
This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Current Smoker, Tobacco Smoking
- What is being tested?
- Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available), Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available) and Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 20 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Current smoker with an average of at least 3 cigarettes/day
- Motivated to quit within the next 30 days
- Valid home address in Utah, Nevada, and Arizona
- Functioning telephone number and access to reliable wifi
- Can speak, read, and write in English
- At least marginal health literacy (as determined by 45 or greater on REALM literacy test)
Who cannot join
- Contraindication for nicotine patch or gum
- Current use of tobacco cessation medications or other aids (i.e. buproprion)
- Pregnancy or lactation (as self-reported)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs
This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.
Read the detailed description
Investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts. Investigate whether, what type, and under what conditions (e.g., current state of vulnerability and/or receptivity) a prompt to engage the individual in self-regulatory activities via mobile app increases engagement, hence reduces vulnerability.
The proposed research will help build a comprehensive conceptual, technical, and empirical foundation necessary to develop effective Just-in-Time-Adaptive-Interventions (JITAIs) based on dynamic models of vulnerability and receptivity. In the micro-randomized trial (MRT), Ecological momentary assessments (EMAs) assessed proximal engagement with self-regulatory strategies, substance use, and other contextual factors after each micro-randomization.
- Conditions
- Current Smoker, Tobacco Smoking
- Being tested
- Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available), Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available), Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available), Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available), Messages recommending low effort strategies (when participants did not complete the 2-question survey)
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available)Behavioural
Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.
Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available)Behavioural
Participants receive messages tailored for situations when they are not experiencing negative affect \& cigarettes are available.
Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available)Behavioural
Participants receive messages tailored for situations when they are experiencing negative affect \& cigarettes are not available.
Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available)Behavioural
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Messages recommending low effort strategies (when participants did not complete the 2-question survey)Behavioural
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
More effortful activity: MoodsurfBehavioural
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
More effortful activity: MeditateBehavioural
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
More effortful activity: JoyBehavioural
Smart phone app that teaches participants to practice breathing exercise.
More effortful activity: ImagineBehavioural
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
More effortful activity: NoticeBehavioural
Smart phone app that teaches participants to accept their thoughts and feelings.
| Study group | Role | What they receive |
|---|---|---|
| Current Smoker | Experimental | Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy. Receives: Behavioral: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available); Behavioral: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available); Behavioral: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available); Behavioral: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available); Behavioral: Messages recommending low effort strategies (when participants did not complete the 2-question survey); Behavioral: More effortful activity: Moodsurf; Behavioral: More effortful activity: Meditate; Behavioral: More effortful activity: Joy; Behavioral: More effortful activity: Imagine; Behavioral: More effortful activity: Notice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy.
Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below.
The three EMA items used to operationalize PE were:
- "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No);
- "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No);
- "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No).
Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.
Measured: 1 hour following micro-randomization
Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment.
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy.
Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below.
The three EMA items used to operationalize PE were:
- "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No);
- "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No);
- "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No).
Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.
Measured: 1 hour following micro-randomization
Secondary outcomes (3)
Proximal Cigarette Use
Proximal Cigarette Use (PCU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal Cigarette Use was created, coded as 1 if the response included "Cigarettes" and 0 otherwise.
This outcome measure reports the proportion that reported PCU at 1 hour following micro-randomization.
The intent of this Outcome Measures is to report overall PCU use according to participant's self-reported engagement with self-regulatory strategies.
Measured: approximately 1 hour following the decision point
Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use
Proximal Nicotine-Containing Non-Cessation Product Use (NCNCP) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal NCNCP Use was created, coded as 1 if the response included "Cigarettes", "Vape pen, JUUL, or e-cigarette," "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise.
This outcome measure will report the proportion that reported NCNCP Use at 1 hour following micro-randomization.
Measured: approximately 1 hour following the decision point
Proximal Tobacco Product Use (PTPU) Use
Proximal Nicotine-Containing Non-Cessation Product Use (PTPU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of PTPU was created, coded as 1 if the response included "Cigarettes", "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise.
This outcome measure will report the proportion that reported PTPU at 1 hour following micro-randomization.
Measured: approximately 1 hour following the decision point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start27 Aug 2020
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
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.
- Other trials for Current SmokerStudies 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
- Randomised
- Intervention model
- Single group
- Model description
- Micro-Randomized Trial (MRT) in the development of data-driven behavioral interventions.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Wetter, PhD, Principal investigator, University of UtahInbal Nahum-Shani, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376489
- Sponsor's protocol ID
- 112287
- Other IDs
- U01CA229437-01
- Acronym
- MARS
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2020
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). Before sharing data, data will be stripped of all personal identifiers and all identifying codes. Data will be deemed either sensitive or low-risk, based on our characterization of the possibility of deductive disclosure. Request for sensitive data will be vetted through an assessment of both the requestor's credentials and potential risks. Note that our risk analysis will be based on a joint consideration of the total risk based on all data products requested.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs
- ClinicalTrials.gov ID
- NCT04376489
- Acronym / sponsor ID
- MARS / 112287
- Conditions
- Current Smoker, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Michigan, National Cancer Institute (NCI)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.
Detailed description
Investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts. Investigate whether, what type, and under what conditions (e.g., current state of vulnerability and/or receptivity) a prompt to engage the individual in self-regulatory activities via mobile app increases engagement, hence reduces vulnerability.
The proposed research will help build a comprehensive conceptual, technical, and empirical foundation necessary to develop effective Just-in-Time-Adaptive-Interventions (JITAIs) based on dynamic models of vulnerability and receptivity. In the micro-randomized trial (MRT), Ecological momentary assessments (EMAs) assessed proximal engagement with self-regulatory strategies, substance use, and other contextual factors after each micro-randomization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Micro-Randomized Trial (MRT) in the development of data-driven behavioral interventions.
| Arm | Type | Receives |
|---|---|---|
| Current Smoker | Experimental | Behavioral: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available), Behavioral: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available), Behavioral: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available), Behavioral: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available), Behavioral: Messages recommending low effort strategies (when participants did not complete the 2-question survey), Behavioral: More effortful activity: Moodsurf, Behavioral: More effortful activity: Meditate, Behavioral: More effortful activity: Joy, Behavioral: More effortful activity: Imagine, Behavioral: More effortful activity: NoticeWithin-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Current smoker with an average of at least 3 cigarettes/day
- Motivated to quit within the next 30 days
- Valid home address in Utah, Nevada, and Arizona
- Functioning telephone number and access to reliable wifi
Key exclusion criteria (3 listed)
- Contraindication for nicotine patch or gum
- Current use of tobacco cessation medications or other aids (i.e. buproprion)
- Pregnancy or lactation (as self-reported)
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 |
|---|---|---|
| Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available)Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available. | Behavioural | Current Smoker |
| Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available)Participants receive messages tailored for situations when they are not experiencing negative affect \& cigarettes are available. | Behavioural | Current Smoker |
| Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available)Participants receive messages tailored for situations when they are experiencing negative affect \& cigarettes are not available. | Behavioural | Current Smoker |
| Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available)Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available. | Behavioural | Current Smoker |
| Messages recommending low effort strategies (when participants did not complete the 2-question survey)Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available. | Behavioural | Current Smoker |
| More effortful activity: MoodsurfSmart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood. | Behavioural | Current Smoker |
| More effortful activity: MeditateSmart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation. | Behavioural | Current Smoker |
| More effortful activity: JoySmart phone app that teaches participants to practice breathing exercise. | Behavioural | Current Smoker |
| More effortful activity: ImagineSmart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings. | Behavioural | Current Smoker |
| More effortful activity: NoticeSmart phone app that teaches participants to accept their thoughts and feelings. | Behavioural | Current Smoker |
Primary outcome
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment
Time frame: 1 hour following micro-randomization
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were: 1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No); 2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No); 3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No). Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.
Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment.
Time frame: 1 hour following micro-randomization
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were: 1. "Think about the most recent tip or activity recommended by MARS. Did you use it in the last hour?" (Yes or No); 2. "In the last hour, did you use any other tip or activity recommended by MARS?" (Yes or No); 3. "In the last hour, did you use any other tip or activity not included in MARS?" (Yes or No). Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant.
3 secondary outcomes
Proximal Cigarette Use
Time frame: approximately 1 hour following the decision point
Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use
Time frame: approximately 1 hour following the decision point
Proximal Tobacco Product Use (PTPU) Use
Time frame: approximately 1 hour following the decision point
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). Before sharing data, data will be stripped of all personal identifiers and all identifying codes. Data will be deemed either sensitive or low-risk, based on our characterization of the possibility of deductive disclosure. Request for sensitive data will be vetted through an assessment of both the requestor's credentials and potential risks. Note that our risk analysis will be based on a joint consideration of the total risk based on all data products requested.
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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. This study is not recruiting at the moment.
David Wetter, PhD principal investigator
University of Utah
Inbal Nahum-Shani, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available), Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available) and Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available) in people with Current Smoker and Tobacco Smoking, run by University of Utah 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 7 inclusion and 3 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 31 Aug 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?
Yes. Results are posted in the registry (first posted 29 Jul 2026). 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?
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment (time frame: 1 hour following micro-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 31 Aug 2026.