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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84102

Other trials in United States

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.

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 groups in NCT04376489
Study groupRoleWhat they receive
Current SmokerExperimentalWithin-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.

  1. 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:

    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.

    Measured: 1 hour following micro-randomization

  2. 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:

    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.

    Measured: 1 hour following micro-randomization

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted6 May 2020
  2. Study start27 Aug 2020
  3. Primary completion20 Oct 2023
  4. Study completion20 Oct 2023

Resources

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)
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
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.

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.

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