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Completed

NCT Number: NCT04376489

Project MARS: Mobile-Assistance for Regulating Smoking

This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Contraindication for nicotine patch or gum
  • Current use of tobacco cessation medications or other aids (i.e. buproprion)
  • Pregnancy or lactation (as self-reported)

Treatment and study plan

Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available)

Behavioral

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)

Behavioral

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)

Behavioral

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)

Behavioral

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)

Behavioral

Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.

More effortful activity: Moodsurf

Behavioral

Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.

More effortful activity: Meditate

Behavioral

Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.

More effortful activity: Joy

Behavioral

Smart phone app that teaches participants to practice breathing exercise.

More effortful activity: Imagine

Behavioral

Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.

More effortful activity: Notice

Behavioral

Smart phone app that teaches participants to accept their thoughts and feelings.

Primary outcomes

  1. 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:

    • "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.

  2. 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:

    • "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.

Secondary outcomes

  1. Proximal Cigarette Use

    Time frame: approximately 1 hour following the decision point

    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.

  2. Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use

    Time frame: approximately 1 hour following the decision point

    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.

  3. Proximal Tobacco Product Use (PTPU) Use

    Time frame: approximately 1 hour following the decision point

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Michigan

Registry information

Official study title

Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs

Acronym: MARS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 6, 2020
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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