- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04720625
Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers (A2Q)
Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Adapt2Quit trial (NCT04720625) is a randomized controlled trial testing a machine-learning-driven text messaging system aimed at increasing smoking cessation rates among socioeconomically disadvantaged adults.
The 6-month study compares an adaptive, personalized motivational messaging intervention against standard Quitline facilitation, utilizing AI to select tailored behavioral prompts based on user feedback.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Health
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current smoker
- Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education)
- English-speaking
- Active in care (at least two clinical visits in the last year)
- Have a texting-enabled cell phone
Exclusion Criteria:
- Not a current smoker
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
- Pilot study participants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adapt2Quit
These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months.
|
Motivational text messages and quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as quitline facilitation messages.
|
|
Active Comparator: Control
These participants will receive quitline facilitation-only messaging for 6 months.
|
Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months
Time Frame: 6-months post-randomization
|
Participants who self-reported no tobacco use in the past 7 days at the 6-month follow-up underwent biochemical verification using the CoVita Smokerlyzer breath carbon monoxide (CO) monitor.
Participants with a CO measurement of ≤6 ppm were classified as abstinent; those with a CO measurement of >6 ppm were classified as tobacco users.
|
6-months post-randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Self-Reported 7-Day Point Prevalence Cigarette Abstinence at 6 Months
Time Frame: 6-months post-randomization
|
Self-reported cigarette abstinence was assessed at the 6-month follow-up using the question: "Do you currently smoke cigarettes, even one puff in the last 7 days?"
Participants who answered "No" were classified as self-reported abstinent.
|
6-months post-randomization
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rajani Sadasivam, PhD, Associate professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00018991
- 1R01CA240551-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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