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

Study Overview
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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.

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

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: Adapt2Quit
* Behavioral: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapt2Quit<br>These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months. | Behavioral: Adapt2Quit<br>* 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.<br>|
| Active Comparator: Control<br>These participants will receive quitline facilitation-only messaging for 6 months. | Behavioral: Control<br>* Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |