Web Assisted Tobacco Intervention With Community Colleges (WATI)
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Purpose
This trial will test the effectiveness of an enhanced web-based smoking cessation intervention for student smokers at 2-year Community Colleges. Young adults continue to be understudied, so more studies of cessation interventions are needed to generate an acceptable level of strength of evidence regarding quit rates, particularly so for Community College students for whom little data on cessation are available. Students (research subjects) will be directed to one of two intervention websites with various levels of novel interactive and social network features, including a variety of better-practice features recommended by recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking).
Our study hypothesizes that students with access to an enhanced website will have higher rates of self-reported intention to quit, a higher number of quit attempts at 6-months compared to those in in a non-enhanced website. Overall, this study will evaluate evidence for a novel enhanced cessation intervention model and will add to our understanding of successful intervention with an understudied population of primarily young adult Community College smokers. The intervention components will be replicable and, if effective, the methodology is applicable across populations, and has the potential for broad public health impact through improved delivery of effective stop smoking interventions via the internet.
| Condition | Intervention |
|---|---|
|
Tobacco Dependence |
Behavioral: Enhanced Web Assisted Tobacco Intervention Behavioral: Basic Web Assisted Tobacco Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Web Assisted Tobacco Intervention With Community Colleges |
- Biochemically verified abstinence from tobacco [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]Our primary outcome is biochemically-verified point-prevalence abstinence at 6 months, defined as no cigarettes in the past 7 days (not even a puff) and no other tobacco use. Biochemical verification will measure salivary cotinine (<10ng/ml confirms abstinence). Using Intent-to-Treat analysis, subjects who drop out or refuse biochemical verification will be considered smokers. We will also assess prolonged abstinence, defined as no smoking or other tobacco use following a grace period for cessation (defined for the current trial as 1 month).
- Stage of Change [ Time Frame: 6 months ] [ Designated as safety issue: No ]An additional outcome will be self-reported via an online questionnaire at 6 month Follow-up. This outcome includes 1) self-efficacy (confidence in ability to quit smoking for good), and 2) intention to quit ("Stage of Change": already quit, planning to quit in 30 days, planning to quit in 6 months, or not planning to quit).
| Estimated Enrollment: | 1440 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Enhanced Web Assisted Intervention
Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.
|
Behavioral: Enhanced Web Assisted Tobacco Intervention
Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking).
Other Names:
|
|
Active Comparator: Basic Web Assisted Intervention.
Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features.
|
Behavioral: Basic Web Assisted Tobacco Intervention
Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18 or older
- Smoke at least 1 cigarette per day on average
- Attendance at Community College
Exclusion Criteria:
- Age 17 or younger
- Nonsmoker
- Not attending a Community College
Contacts and Locations| Contact: Scott McIntosh, PhD | (585) 802-9944 | scott_mcintosh@urmc.rochester.edu |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Scott McIntosh, PhD 585-802-9944 scott_mcintosh@urmc.rochester.edu | |
| Principal Investigator: Scott McIntosh, PhD | |
| Principal Investigator: | Scott McIntosh, PhD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Scott McIntosh, Associate Professor, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01692730 History of Changes |
| Other Study ID Numbers: | RSRB00040730, R01CA152093 |
| Study First Received: | September 17, 2012 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of Rochester:
|
Smoking Cessation Web Assisted Tobacco Intervention |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013