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

NCT ID: NCT04720625

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-28

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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).

Study Groups

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Adapt2Quit

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

Group Type EXPERIMENTAL

Adapt2Quit

Intervention Type 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.

Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Baystate Health

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Rajani Sadasivam

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajani Sadasivam, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Baystate Health

Springfield, Massachusetts, United States

Site Status

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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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. 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.

Reference Type DERIVED
PMID: 40239194 (View on PubMed)

Other Identifiers

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1R01CA240551-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00018991

Identifier Type: -

Identifier Source: org_study_id

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