Tobacco Smoking
Conditions
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.
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.
Interventions
BEHAVIORALAdapt2Quit
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.
BEHAVIORALControl
Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
Sponsors
University of Massachusetts, Worcester
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Johns Hopkins University
Baystate Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-Reported 7-Day Point Prevalence Cigarette Abstinence at 6 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRajani Sadasivam, PhD
Associate Professor
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 685 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 297 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 46 Participants |
| Race (NIH/OMB) White | 392 Participants |
| Region of Enrollment United States | 757 participants |
| Sex: Female, Male Female | 487 Participants |
| Sex: Female, Male Male | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 312 | 1 / 321 |
| other Total, other adverse events | 0 / 312 | 0 / 321 |
| serious Total, serious adverse events | 0 / 312 | 0 / 321 |
Outcome results
None listed