Trial Information

Web Assisted Tobacco Intervention With Community Colleges

Purpose of the study. This group randomized controlled trial will test the effectiveness of
an enhanced web-based cessation intervention for student smokers at 2-year Community
Colleges (CC). Compared to the smoking rates of the general population (18%), smoking rates
among CC students varies but remains substantially higher (28-30%). Evaluations of
Web-Assisted Tobacco Interventions (WATI) for smoking cessation treatment with young adults
in more traditional 4-year college settings have yielded encouraging preliminary data
regarding intervention effectiveness. Young adults continue to be understudied, so
additional randomized designed studies of cessation interventions are needed to generate an
acceptable level of strength of evidence regarding quit rates, particularly so for CC
students for whom little data on cessation are available. This critical population is likely
to be increasing for several reasons, including President Obama's American Graduation
Initiative, which provides resources to increase Community College enrollment by 5 million
additional graduates by 2020. In the proposed trial, subjects on campuses randomized to the
basic intervention arm will be directed to a minimally interactive website standardized to
comply with 2008 DHHS Clinical Practice Guidelines for adult smokers. Those at campuses in
the enhanced intervention arm will be directed to an enhanced site that adds novel
interactive and social network features, including a variety of better-practice features
recommended by WATI workshops, recent literature, and technologically advanced proactive
features (e-mails, SMS texting, and social networking). Our study has the following
Specific Aims:

Primary Aims Aim 1:To test the effectiveness of an Enhanced interactive WATI (E-WATI) vs. a
Basic WATI (B-WATI) among Community College students (primarily young adults). The online
methodology will maximize population access and, if effective, can be recommended as a
feasible cessation option.

Aim 2:To evaluate both WATI options for overall usability, as well as for the usability and
perceived helpfulness of key features (i.e., basic, novel, high-tech, proactive and
interactive components), and their relationship to cessation.

Secondary Aim Aim 3:To develop and evaluate strategies to recruit and retain an understudied
population of Community College smokers using WATI interventions. Evaluation of recruitment
strategies will be useful to the current trial, as well as well as to future trials with
this population.

This study will be conducted in three phases, using a mixed methods approach. Phase 1
qualitative research in Year 01 will help guide and refine recruitment and retention and
delivery strategies. In Phase 2, a group randomized trial in Years 02-04 will randomize 16
Community Colleges (8 matched pairs; 1,440 smokers) to one of two interventions: 1) B-WATI -
a basic website for cessation comparable to those for general adult populations, including
established evidence-based cessation information and features; or 2) E-WATI - an enhanced
and highly interactive website for cessation. Phase 3 dissemination in Year 05 will involve
interpretation of study results, guidance for further research, and dissemination of study
findings, including recommendations for including WATI cessation for campus-based referral
strategies. To address the Specific Aims, our study has these Primary Hypotheses:

H1.0: Smokers in E-WATI will have higher biochemically verified point-prevalence abstinence
at 6-months compared to those in the B-WATI group. Secondary hypotheses for smoking-related
outcomes explore: (H1.1) higher rates of self-reported intention to quit; (H1.2), a higher
number of quit attempts at 6-months in the E-WATI group compared to those in B-WATI and
higher quit rates at 12 months for the subsample available for follow-up; (H1.3) higher
number of prolonged abstinence participants at 6-months, and (H1.4), greater movement
through Stages of Change.

H2.0: Smokers in the E-WATI group, compared to those in B-WATI, will demonstrate more
interactivity and engagement with web-based features and interventions as measured by
website usability analysis and higher self-report of the number and type of selected online
strategies at 6-month follow-up.

H3.0: Web-based features will be perceived as more helpful for smoking cessation by those
in E-WATI compared to those in B-WATI as measured by the 6-month follow-up questionnaire.

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 WATI methodology is applicable across heterogeneous
populations and geographic areas, and has the potential for broad public health impact
through improved delivery of effective cessation interventions via the internet.