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Web Assisted Tobacco Intervention With Community Colleges (WATI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692730
First Posted: September 25, 2012
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Scott McIntosh, University of Rochester
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Web Assisted Tobacco Intervention With Community Colleges

Resource links provided by NLM:


Further study details as provided by Scott McIntosh, University of Rochester:

Primary Outcome Measures:
  • Number of Participants Who Self-report Abstinence From Tobacco [ Time Frame: 6 month follow-up ]
    Our primary outcome is self-reported abstinence at the six month evaluation point. Abstinence outcomes at this time point are defined in three ways: 1) as self-reported abstinence (no cigarettes or other tobacco use) in the past 7 days prior to this six month time point, 2) or as no use in the past 30 days prior to this six-month time point (the 30 day period is the more conservative measure), or 3) self-reported prolonged abstinence from the time of a specific self-reported cessation date.


Secondary Outcome Measures:
  • Number of Participants With Biochemically Verified Abstinence From Tobacco [ Time Frame: 6 month follow-up ]
    Our primary outcome is biochemically-verified point-prevalence abstinence at 6 months. If participant self-reports no cigarettes (or other tobacco use) in the past 7 days, the past 30 days, or since a specific self-reported cessation date, biochemical verification will be conducted to measure salivary cotinine (a cut off of <10ng/ml confirms self-reported abstinence for at least the previous 7 days). Using Intent-to-Treat analysis, subjects who drop out or refuse biochemical verification will be considered smokers.


Enrollment: 1452
Study Start Date: October 2012
Study Completion Date: August 2016
Primary Completion Date: August 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692730


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
National Library of Medicine (NLM)
Investigators
Principal Investigator: Scott McIntosh, PhD University of Rochester
  More Information

Responsible Party: Scott McIntosh, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01692730     History of Changes
Other Study ID Numbers: RSRB00040730
R01CA152093 ( U.S. NIH Grant/Contract )
R01CA152093-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 17, 2012
First Posted: September 25, 2012
Results First Submitted: April 19, 2017
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders