- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982825
Innovative Web-Based Intervention for Smoking Cessation Among College Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tobacco use is the leading cause of cancer death. Because smokers who quit by 30 have cancer death risk similar to non-smokers, promoting cessation early in life is critical. U.S. colleges/universities, enrolling >14 million students/year (40% of those aged 18 to 24), are an important venue to reach young adult smokers. While daily tobacco use in the U.S. has declined to 18.1%, nondaily smoking (smoking on some days but not every day) is increasing, particularly among young adults and African Americans. Moreover, young smokers and nondaily smokers (half of young adult smokers9), respectively, are less likely to seek help in quitting; thus, innovative strategies are needed to assist cessation early in life, particularly among those who may not be motivated to quit or seek help. Unfortunately, no research has focused on developing a cessation intervention that addresses a broad range of smoking patterns (nondaily to daily smoking) or diverse campus settings among ethnically diverse student populations. Web-based interventions offer promise in helping college students to quit, given high rates of Internet use and web capacity to provide tailored cessation messages. A novel approach to delivering cessation information might be to address broader lifestyle issues and apply market research strategies such as those used by the tobacco industry to identify market segments of smokers (groups of people with similar interests, goals, values) in order to target and engage these groups more effectively. Applying this strategy to an online cessation intervention should enhance both intervention use and processing of intervention messages, leading to greater abstinence rates.
Our specific aims are:
- Aim 1: To develop and refine a tailored web-based intervention for smoking cessation targeting young adults representing a range of sociodemographic backgrounds, particularly including those from low SES and African American backgrounds, and a range of smoking levels (i.e., nondaily, low-level smokers to daily, heavy smokers) attending college.
- Aim 2: To test the usability, acceptability, and feasibility of the intervention among a sample of college student smokers.
- Aim 3: To determine the potential effect of the intervention on smoking cessation, smoking level, quit attempts, and contextual factors (e.g., mood, alcohol use, social factors) among a sample of college student smokers from various backgrounds and smoking patterns.
This research will be addressed through three phases. Phase 1 will involve the development of the web-site infrastructure, securing incentives, developing website content (dramas, stories), and developing the tailored feedback infrastructure. Phase 2 will involve expert feedback, which will be integrated into the next program version. Phase 3 involves a 6-week trial among a small sample of young adults at two college campuses (university; community/technical college) in Georgia (N = 200). At end-of-intervention, we will assess usability, acceptability, and feasibility of the program; smoking status and level; and psychosocial factors related to smoking (e.g. alcohol use, mood). Assessments of smoking status/level and psychosocial factors will also be conducted at 6 weeks post-intervention. The primary outcomes in the trial are usability, acceptability, and feasibility (self-reported and observed website utilization [check-in, activity]). Secondary outcomes include: (1) message processing (self-reported attention to messages, perceived relevance, and other message use items);19 (2) 7-day and 30-day point prevalence abstinence at end-of-treatment (6 weeks) and at 6-week follow-up (12 weeks) in order to appropriately examine cessation among daily and nondaily smokers; (3) smoking level at 6 and 12 weeks; (4) number of quit attempts since baseline; and (5) change in other contextual factors (mood, alcohol use, social aspects).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ≥ 18 and less than 30,
- enrolled at least part-time,
- intending to be in one of the two participating schools (Georgia State University, Valdosta State University) for the academic year,
- able to read English, and
- any cigarette smoking in previous 30 days.
Exclusion Criteria:
- Significant mental health problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online intervention arm
Bi-weekly (MTh) for 6 weeks, participants will receive an email asking them to report number of cigarettes smoked, alcoholic drinks, engagement in physical activity, and overall mood the two-three days before.
Upon answering, they will be launched to the site which will contain health messaging focused on smoking and other health topics.
|
See online intervention arm
|
Active Comparator: Online control arm
Control participants will receive bi-weekly emails (MTh) over 6 weeks but in the context of a standard smoking cessation website.
Because we are primarily testing the check-ins, tailored feedback, and market research-based mini-drama and other web content, we feel that this control group will isolate the hypothesized active elements of our program.
|
See online control arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability
Time Frame: Week 6
|
We will assess the acceptability of the intervention (i.e., reported satisfaction and engagement with the intervention).
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cessation
Time Frame: Week 6, Week 12
|
We will assess cessation (self-reported).
|
Week 6, Week 12
|
Cigarette consumption
Time Frame: Week 6, Week 12
|
We will assess cigarette consumption to examine changes in consumption over time.
|
Week 6, Week 12
|
Quit Attempts
Time Frame: Week 6, Week 12
|
We will assess quit attempts from baseline to follow up.
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Week 6, Week 12
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00059657
- 1R43TR000358-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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