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
112
1 country
1
Brief Summary
This study aims to identify states of vulnerability for lapse, identify states of receptivity for engaging in self-regulatory activities, and 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
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedOctober 26, 2022
October 1, 2022
2.3 years
January 9, 2020
October 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Biochemically Verified Smoking Abstinence
Smoking abstinence will be completed via self-reported status from participants which are biochemically verified by either expired carbon monoxide via a breathalyzer or a cotinine sample as needed if a participant is unable to attend a visit in-person.
Post-quit date - 6-month follow-up
Study Arms (3)
Brief cognitive/behavioral strategies
EXPERIMENTALEffortful self-regulatory activities
EXPERIMENTALNo activities
NO INTERVENTIONInterventions
Participants receive messages tailored for situations when they experiencing negative affect \& cigarettes are available.
Participants receive messages tailored for situations when they cigarettes are available.
Participants receive messages tailored for situations when they experiencing negative affect.
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
- Functioning telephone number
- 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
- 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
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Wetter, PhD
University of Utah
- PRINCIPAL INVESTIGATOR
Inbal Nahum-Shani, PhD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 9, 2020
First Posted
May 6, 2020
Study Start
August 27, 2020
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
October 26, 2022
Record last verified: 2022-10
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.