Observational Study Evaluating a Smoking Cessation Program and Its Association With Long-Term Smoking Abstinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 371
- Locations
- 2
- Primary Endpoint
- Initial Cessation
Study Overview
Brief Summary
This observational study evaluates a structured smoking cessation program delivered via weekly group sessions. The primary objective is to assess participant-reported smoking abstinence following completion of the program and at 6-month follow-up.
Secondary objectives include evaluating changes in self-reported anxiety related to smoking cessation and assessing whether participants report reduced need for ongoing trigger management. The study will also characterize the demographic profile of participants enrolled in the program.
Participants will attend weekly 1-hour group sessions conducted via videoconference over an 8-week period. Data collection includes a baseline demographic questionnaire, an end-of-program questionnaire, and a 6-month follow-up questionnaire assessing continued smoking status and related measures.
All study activities are conducted remotely, and participants may be located anywhere within the United States.
Detailed Description
This observational study evaluates a structured, group-based smoking cessation program delivered remotely to adult participants residing in the United States. The program is conducted via weekly videoconference sessions and may be offered in both English and Spanish to accommodate participant language needs.
Eligible participants include individuals who currently use combustible cigarettes and/or electronic nicotine delivery systems (vaping products) and who are interested in attempting smoking cessation. Participants will be enrolled in an 8-week program consisting of weekly 1-hour group sessions, with approximately 15-20 participants per group.
The program is behavioral and educational in nature and does not include pharmacologic interventions or nicotine replacement therapies. Sessions are designed to provide participants with strategies intended to support smoking cessation through behavioral change, peer support, and self-directed techniques. The group-based format is intended to provide a supportive environment that may facilitate engagement and adherence to the program.
Data collection includes baseline demographic information, end-of-program assessment, and a 4-to-6 month follow-up evaluation. Outcome measures focus on participant-reported smoking status, as well as self-reported changes in anxiety related to smoking cessation and perceived need for ongoing trigger management.
The study does not evaluate the health benefits of smoking cessation, which are well established in the existing literature. Rather, the focus of this study is to assess participant outcomes associated with participation in the program and to describe the characteristics of individuals who engage in this intervention.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •must be addicted to nicotine either by cigarette or vaping
- •must have access to an internet connected device, laptop, or smartphone
- •must be 18 years old or older
Exclusion Criteria
- •currently enrolled in any weight-loss program
- •currently enrolled in any behavioral modification program
- •currently using nicotine replacement therapy of any kind
Arms & Interventions
Smoking Cessation Program Participants
Participants enrolled in a structured, group-based smoking cessation program delivered via weekly 1-hour videoconference sessions over an 8-week period. The program is behavioral and educational in nature and does not include pharmacologic interventions or nicotine replacement therapies.
Intervention: Quit Center cessation program (Behavioral)
Outcomes
Primary Outcomes
Initial Cessation
Time Frame: 8 weeks
percentage of participants that report quitting smoking by the end of the program
Smoking Abstinence at End of Program
Time Frame: 8 Weeks
Percentage of participants who self-report abstinence from smoking and/or vaping at the end of the 8-week program.
Secondary Outcomes
- Extended Cessation(6 months)
- Permanent Cessation(1 year)
- Self-reported Tobacco Abstinence at 4-6 Months Post-program(4-6 months post-program completion)