University of Vermont
Burlington, Vermont, 05405, United States
NCT Number: NCT04379388
The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.
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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Burlington, Vermont, 05405, United States
Using content and strategy developed from the formative research phase, this randomized smoking cessation trial will test the impact of a tailored cessation intervention for socioeconomically-disadvantaged young adult (SDYA) smokers compared to a usual-care control on intervention engagement, self-efficacy to quit, and 30-day point prevalence abstinence at 3-month follow-up.
This study will take place over a 3-month period. Individuals who complete the screening survey and are eligible to participate will be asked to complete a 15-20 minute baseline survey at the start of the study. This survey will ask questions about use of mobile phones, tobacco use, recent alcohol and other drug use, concerns about the coronavirus outbreak and how it may affect personal tobacco use, and physical activity. After the first survey, participants will be assigned randomly to one of two study groups:
Group A: Referral to a quit smoking hotline (quit line)
Group B: Referral to a quit smoking hotline (quit line), plus enrollment in a web and text-based smoking cessation intervention.
Participants in both groups will be enrolled after completing the following steps, in order:
To complete enrollment, participants in Group B will also be required to register for an account on BecomeAnEx.org and enroll in text messages on the site. Once registered, Group B participants will be enrolled in a text message program customized for this study and will need to respond to the initial message from the text message platform to initiate text messages.
Participants in Group B will receive daily text messages for 3 months with content delivered through the Truth Initiative's BecomeAnEx digital quit smoking platform. They will also receive brief (1-2 minute) weekly check-in surveys related to the week's messages and smoking status during this time.
At 3-months, participants in both groups will receive the 15-minute follow-up assessment. Participants in both groups who report quitting smoking at 3-months will be mailed a kit in order to take a saliva test to measure the amount of cotinine, a metabolite of nicotine, in their saliva. Participants who report smoking at the 3-month follow-up will not receive this saliva test.
All study procedures will take place remotely, with surveys conducted online. Participants in Group A will be paid at least $30 for participation and up to $80. Participants in Group B will be paid at least $40 for participation and up to $170.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention
Time frame: Assessed at 3-month follow-up
Self-reported smoking abstinence and biochemical validation (saliva cotinine)
Time frame: Assessed at 3-month follow-up
Confidence to quit within the next month (7days) on 0-10 scale
Time frame: 12 weeks
Completing 75% or more of 12 weekly check-ins
Time frame: Assessed at 3-month follow-up
Self-reported smoking abstinence
Time frame: Assessed at 3-month follow-up
Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit
Time frame: Assessed 3-month follow-up
4 items pertaining to quit support from the text messages
Time frame: Assessed at 3-month follow-up
Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products
University of Vermont
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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