Web Assisted Tobacco Intervention With Community Colleges (WATI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Rochester
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Scott McIntosh, University of Rochester
ClinicalTrials.gov Identifier:
NCT01692730
First received: September 17, 2012
Last updated: August 29, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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:
  • Smoking Cessation Intervention
  • Web based smoking cessation
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:
  • Static Web Assisted Tobacco Intervention
  • Information only

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692730

Contacts
Contact: Scott McIntosh, PhD (585) 802-9944 scott_mcintosh@urmc.rochester.edu

Locations
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         
Sponsors and Collaborators
University of Rochester
Investigators
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: August 29, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Rochester:
Smoking Cessation
Web Assisted Tobacco Intervention

ClinicalTrials.gov processed this record on October 29, 2014