Project MARS: Mobile-Assistance for Regulating Smoking
Novel Use of mHealth Data to Identify States of Vulnerability and Receptivity to JITAIs
2 other identifiers
interventional
114
1 country
1
Brief Summary
This study aims to investigate approaches to capitalize on states of vulnerability and receptivity to deliver real-time self-regulation prompts among smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedResults Posted
Study results publicly available
July 29, 2026
CompletedJuly 29, 2026
July 1, 2026
3.1 years
January 9, 2020
November 24, 2025
July 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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: 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.
1 hour following micro-randomization
Secondary Outcomes (3)
Proximal Cigarette Use
approximately 1 hour following the decision point
Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use
approximately 1 hour following the decision point
Proximal Tobacco Product Use (PTPU) Use
approximately 1 hour following the decision point
Study Arms (1)
Current Smoker
EXPERIMENTALWithin-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.
Interventions
Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.
Participants receive messages tailored for situations when they are not experiencing negative affect \& cigarettes are available.
Participants receive messages tailored for situations when they are experiencing negative affect \& cigarettes are not available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
Smart phone app that teaches participants to practice breathing exercise.
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
Smart phone app that teaches participants to accept their thoughts and feelings.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Contraindication for nicotine patch or gum
- Current use of tobacco cessation medications or other aids (i.e. buproprion)
- Pregnancy or lactation (as self-reported)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- University of Michigancollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- IIT Data Management Team
- Organization
- Research Compliance Office, Huntsman Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David Wetter, PhD
University of Utah
- PRINCIPAL INVESTIGATOR
Inbal Nahum-Shani, PhD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
May 6, 2020
Study Start
August 27, 2020
Primary Completion
October 20, 2023
Study Completion
October 20, 2023
Last Updated
July 29, 2026
Results First Posted
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The PIs and the research team will work to make the data available in a reasonable amount of time after its collection and following the acceptance for publication of the main findings. Rules for maintaining and distributing data of the University of Utah, the University of Michigan, and the NIH will be followed.
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.