<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692730</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00040730</org_study_id>
    <secondary_id>R01CA152093</secondary_id>
    <secondary_id>R01CA152093-01A1</secondary_id>
    <nct_id>NCT01692730</nct_id>
  </id_info>
  <brief_title>Web Assisted Tobacco Intervention With Community Colleges</brief_title>
  <acronym>WATI</acronym>
  <official_title>Web Assisted Tobacco Intervention With Community Colleges</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Library of Medicine (NLM)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will test the effectiveness of an enhanced web-based smoking cessation&#xD;
      intervention for student smokers at 2-year Community Colleges. Young adults continue to be&#xD;
      understudied, so more studies of cessation interventions are needed to generate an acceptable&#xD;
      level of strength of evidence regarding quit rates, particularly so for Community College&#xD;
      students for whom little data on cessation are available. Students (research subjects) will&#xD;
      be directed to one of two intervention websites with various levels of novel interactive and&#xD;
      social network features, including a variety of better-practice features recommended by&#xD;
      recent literature, and technologically advanced proactive features (e-mails, SMS texting, and&#xD;
      social networking).&#xD;
&#xD;
      Our study hypothesizes that students with access to an enhanced website will have higher&#xD;
      rates of self-reported intention to quit, a higher number of quit attempts at 6-months&#xD;
      compared to those in in a non-enhanced website. Overall, this study will evaluate evidence&#xD;
      for a novel enhanced cessation intervention model and will add to our understanding of&#xD;
      successful intervention with an understudied population of primarily young adult Community&#xD;
      College smokers. The intervention components will be replicable and, if effective, the&#xD;
      methodology is applicable across populations, and has the potential for broad public health&#xD;
      impact through improved delivery of effective stop smoking interventions via the internet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose of the study. This group randomized controlled trial will test the effectiveness of&#xD;
      an enhanced web-based cessation intervention for student smokers at 2-year Community Colleges&#xD;
      (CC). Compared to the smoking rates of the general population (18%), smoking rates among CC&#xD;
      students varies but remains substantially higher (28-30%). Evaluations of Web-Assisted&#xD;
      Tobacco Interventions (WATI) for smoking cessation treatment with young adults in more&#xD;
      traditional 4-year college settings have yielded encouraging preliminary data regarding&#xD;
      intervention effectiveness. Young adults continue to be understudied, so additional&#xD;
      randomized designed studies of cessation interventions are needed to generate an acceptable&#xD;
      level of strength of evidence regarding quit rates, particularly so for CC students for whom&#xD;
      little data on cessation are available. This critical population is likely to be increasing&#xD;
      for several reasons, including President Obama's American Graduation Initiative, which&#xD;
      provides resources to increase Community College enrollment by 5 million additional graduates&#xD;
      by 2020. In the proposed trial, subjects on campuses randomized to the basic intervention arm&#xD;
      will be directed to a minimally interactive website standardized to comply with 2008 DHHS&#xD;
      Clinical Practice Guidelines for adult smokers. Those at campuses in the enhanced&#xD;
      intervention arm will be directed to an enhanced site that adds novel interactive and social&#xD;
      network features, including a variety of better-practice features recommended by WATI&#xD;
      workshops, recent literature, and technologically advanced proactive features (e-mails, SMS&#xD;
      texting, and social networking). Our study has the following Specific Aims:&#xD;
&#xD;
      Primary Aims Aim 1:To test the effectiveness of an Enhanced interactive WATI (E-WATI) vs. a&#xD;
      Basic WATI (B-WATI) among Community College students (primarily young adults). The online&#xD;
      methodology will maximize population access and, if effective, can be recommended as a&#xD;
      feasible cessation option.&#xD;
&#xD;
      Aim 2:To evaluate both WATI options for overall usability, as well as for the usability and&#xD;
      perceived helpfulness of key features (i.e., basic, novel, high-tech, proactive and&#xD;
      interactive components), and their relationship to cessation.&#xD;
&#xD;
      Secondary Aim Aim 3:To develop and evaluate strategies to recruit and retain an understudied&#xD;
      population of Community College smokers using WATI interventions. Evaluation of recruitment&#xD;
      strategies will be useful to the current trial, as well as well as to future trials with this&#xD;
      population.&#xD;
&#xD;
      This study will be conducted in three phases, using a mixed methods approach. Phase 1&#xD;
      qualitative research in Year 01 will help guide and refine recruitment and retention and&#xD;
      delivery strategies. In Phase 2, a group randomized trial in Years 02-04 will randomize 16&#xD;
      Community Colleges (8 matched pairs; 1,440 smokers) to one of two interventions: 1) B-WATI -&#xD;
      a basic website for cessation comparable to those for general adult populations, including&#xD;
      established evidence-based cessation information and features; or 2) E-WATI - an enhanced and&#xD;
      highly interactive website for cessation. Phase 3 dissemination in Year 05 will involve&#xD;
      interpretation of study results, guidance for further research, and dissemination of study&#xD;
      findings, including recommendations for including WATI cessation for campus-based referral&#xD;
      strategies. To address the Specific Aims, our study has these Primary Hypotheses:&#xD;
&#xD;
      H1.0: Smokers in E-WATI will have higher biochemically verified point-prevalence abstinence&#xD;
      at 6-months compared to those in the B-WATI group. Secondary hypotheses for smoking-related&#xD;
      outcomes explore: (H1.1) higher rates of self-reported intention to quit; (H1.2), a higher&#xD;
      number of quit attempts at 6-months in the E-WATI group compared to those in B-WATI and&#xD;
      higher quit rates at 12 months for the subsample available for follow-up; (H1.3) higher&#xD;
      number of prolonged abstinence participants at 6-months, and (H1.4), greater movement through&#xD;
      Stages of Change.&#xD;
&#xD;
      H2.0: Smokers in the E-WATI group, compared to those in B-WATI, will demonstrate more&#xD;
      interactivity and engagement with web-based features and interventions as measured by website&#xD;
      usability analysis and higher self-report of the number and type of selected online&#xD;
      strategies at 6-month follow-up.&#xD;
&#xD;
      H3.0: Web-based features will be perceived as more helpful for smoking cessation by those in&#xD;
      E-WATI compared to those in B-WATI as measured by the 6-month follow-up questionnaire.&#xD;
&#xD;
      Overall, this study will evaluate evidence for a novel enhanced cessation intervention model&#xD;
      and will add to our understanding of successful intervention with an understudied population&#xD;
      of primarily young adult Community College smokers. The intervention components will be&#xD;
      replicable and, if effective, the WATI methodology is applicable across heterogeneous&#xD;
      populations and geographic areas, and has the potential for broad public health impact&#xD;
      through improved delivery of effective cessation interventions via the internet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Self-report Abstinence From Tobacco</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Biochemically Verified Abstinence From Tobacco</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>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 &lt;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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1452</enrollment>
  <condition>Tobacco Dependence</condition>
  <arm_group>
    <arm_group_label>Enhanced Web Assisted Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basic Web Assisted Intervention.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Web Assisted Tobacco Intervention</intervention_name>
    <description>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).</description>
    <arm_group_label>Enhanced Web Assisted Intervention</arm_group_label>
    <other_name>Smoking Cessation Intervention</other_name>
    <other_name>Web based smoking cessation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Basic Web Assisted Tobacco Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Basic Web Assisted Intervention.</arm_group_label>
    <other_name>Static Web Assisted Tobacco Intervention</other_name>
    <other_name>Information only</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Smoke at least 1 cigarette per day on average&#xD;
&#xD;
          -  Attendance at Community College&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age 17 or younger&#xD;
&#xD;
          -  Nonsmoker&#xD;
&#xD;
          -  Not attending a Community College&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott McIntosh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>April 19, 2017</results_first_submitted>
  <results_first_submitted_qc>November 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 20, 2017</results_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Scott McIntosh</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Smoking Cessation</keyword>
  <keyword>Web Assisted Tobacco Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enhanced Web Assisted Intervention</title>
          <description>Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.&#xD;
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).</description>
        </group>
        <group group_id="P2">
          <title>Basic Web Assisted Intervention.</title>
          <description>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.&#xD;
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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="723"/>
                <participants group_id="P2" count="729"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="498"/>
                <participants group_id="P2" count="502"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="225"/>
                <participants group_id="P2" count="227"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="225"/>
                <participants group_id="P2" count="227"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enhanced Web Assisted Intervention</title>
          <description>Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.&#xD;
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).</description>
        </group>
        <group group_id="B2">
          <title>Basic Web Assisted Intervention.</title>
          <description>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.&#xD;
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.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="723"/>
            <count group_id="B2" value="729"/>
            <count group_id="B3" value="1452"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Collected via online survey.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="723"/>
                    <count group_id="B2" value="729"/>
                    <count group_id="B3" value="1452"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.55048409" spread="9.474060629"/>
                    <measurement group_id="B2" value="28.45541838" spread="9.707011106"/>
                    <measurement group_id="B3" value="28.00482094" spread="9.602390308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="712"/>
                    <count group_id="B2" value="714"/>
                    <count group_id="B3" value="1426"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="256"/>
                    <measurement group_id="B3" value="493"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="475"/>
                    <measurement group_id="B2" value="458"/>
                    <measurement group_id="B3" value="933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Self-report Abstinence From Tobacco</title>
        <description>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.</description>
        <time_frame>6 month follow-up</time_frame>
        <population>The primary outcome time point was six months. These 1,000 participants completed the six month time point evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Web Assisted Intervention</title>
            <description>Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.&#xD;
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).</description>
          </group>
          <group group_id="O2">
            <title>Basic Web Assisted Intervention.</title>
            <description>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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Abstinence From Tobacco</title>
          <description>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.</description>
          <population>The primary outcome time point was six months. These 1,000 participants completed the six month time point evaluation.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="498"/>
                <count group_id="O2" value="502"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Biochemically Verified Abstinence From Tobacco</title>
        <description>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 &lt;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.</description>
        <time_frame>6 month follow-up</time_frame>
        <population>Not all participants provided saliva. Analysis was performed on a total of 109 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Web Assisted Intervention</title>
            <description>Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.&#xD;
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).</description>
          </group>
          <group group_id="O2">
            <title>Basic Web Assisted Intervention.</title>
            <description>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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Biochemically Verified Abstinence From Tobacco</title>
          <description>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 &lt;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.</description>
          <population>Not all participants provided saliva. Analysis was performed on a total of 109 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>No adverse event data was collected for this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Enhanced Web Assisted Intervention</title>
          <description>Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.&#xD;
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).</description>
        </group>
        <group group_id="E2">
          <title>Basic Web Assisted Intervention.</title>
          <description>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.&#xD;
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.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Scott McIntosh</name_or_title>
      <organization>University of Rochester</organization>
      <phone>585-275-0511</phone>
      <email>scott_mcintosh@urmc.rochester.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692730
org study id: RSRB00040730
secondary id: R01CA152093
secondary id: R01CA152093-01A1
nct id: NCT01692730
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants Who Self-report Abstinence From Tobacco
time frame: 6 month follow-up
description: 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.
measure: Number of Participants With Biochemically Verified Abstinence From Tobacco
time frame: 6 month follow-up
description: 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.
arm group label: Enhanced Web Assisted Intervention
arm group type: Experimental
description: Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.
arm group label: Basic Web Assisted Intervention.
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Enhanced Web Assisted Tobacco Intervention
description: 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).
arm group label: Enhanced Web Assisted Intervention
other name: Smoking Cessation Intervention
other name: Web based smoking cessation
intervention type: Behavioral
intervention name: Basic Web Assisted Tobacco Intervention
description: 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.
arm group label: Basic Web Assisted Intervention.
other name: Static Web Assisted Tobacco Intervention
other name: Information only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Scott McIntosh, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Scott McIntosh
investigator title: Associate Professor
mesh term: Tobacco Use Disorder
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 