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

NCT04720625 | Completed DMC

• 2 other identifiers: H000189911R01CA240551-01A1
• Study Type: interventional
• Target: 757
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Time to First Quit Attempt

  From randomization to 6-months post-randomization

Study Arms (2)

Adapt2Quit

EXPERIMENTAL

These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months.

Behavioral: Adapt2Quit

Control

ACTIVE COMPARATOR

These participants will receive quitline facilitation-only messaging for 6 months.

Behavioral: Control

Interventions

Adapt2Quit BEHAVIORAL

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.

Adapt2Quit

Control BEHAVIORAL

Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not a current smoker
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners
• Pregnant women
• Pilot study participants

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Johns Hopkins University: collaborator
• Baystate Health: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Baystate Health

Springfield, Massachusetts, 01199, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• Kamberi A, Weitz B, Flahive J, Eve J, Najjar R, Liaghat T, Ford D, Lindenauer P, Person S, Houston TK, Gauvey-Kern ME, Lobien J, Sadasivam RS, Balakrishnan K. Testing a Machine Learning-Based Adaptive Motivational System for Socioeconomically Disadvantaged Smokers (Adapt2Quit): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 16;14:e63693. doi: 10.2196/63693.

  PMID: 40239194 DERIVED

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Officials

• Rajani Sadasivam, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After completing the screening, informed consent, and baseline data collection, study staff will enter the participant identification number and participant mobile phone number from the survey into an online system, and the system will assign allocation based on the randomization table. Using this technique, both smokers and the staff will be blinded to allocation during the initial session. Then, the research staff will be un-blinded to provide personalized training for intervention and control (note that staff who complete follow-up will be different and blinded to group assignment).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: June 28, 2021
• Primary Completion: October 10, 2024
• Study Completion: March 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)