Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers

Tobacco Smoking Clinical Trial

— A2Q  

Official title:

Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720625
• Other study ID #: H00018991
• Secondary ID: 1R01CA240551-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: University of Massachusetts, Worcester
• Contact: Reem M Najjar
• Phone: 774-275-0890
• Email: Reem.Najjar[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: March 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• Adapt2Quit
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.
• Control
Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Baystate Health	Springfield	Massachusetts
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Baystate Health, Johns Hopkins University, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported Participant Tobacco Cessation Rate (quit rate)	Self-reported 6-month point prevalence cessation (yes/no) will be assessed at 6-month follow-up.	6-months post-randomization
Primary	Biochemical Carbon Monoxide (CO) Verification of Tobacco Cessation	Biochemical carbon monoxide (CO) verification testing will also be done for a small subset of participants, where 0-6 parts per million (PPM) measures a non-smoker and 7+ PPM indicates a current smoker.	6-months post-randomization
Secondary	Time to First Quit Attempt	Self-reported date of first quit attempt since starting the study will be assessed through text message response from participant during the 6-month intervention period.	From randomization to 6-months post-randomization