<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/NCT02207036</url>
  </required_header>
  <id_info>
    <org_study_id>A119678</org_study_id>
    <secondary_id>5K23DA032578</secondary_id>
    <nct_id>NCT02207036</nct_id>
  </id_info>
  <brief_title>Tobacco Status Project: Social Media Intervention for Young Adult Smokers</brief_title>
  <acronym>TSP</acronym>
  <official_title>Social Media Intervention for Young Adult Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial will test the efficacy of a Facebook intervention based on the&#xD;
      Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical&#xD;
      Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized to one of two conditions: (1) a Facebook-delivered&#xD;
      intervention tailored to readiness to quit smoking; or (2) the control condition (referral to&#xD;
      the Smokefree.gov website). The intervention will include 12 weeks of Facebook-based messages&#xD;
      and activities tailored to participants' stage of change.&#xD;
&#xD;
      Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include&#xD;
      measures on smoking patterns and thoughts about abstinence. All participants who report no&#xD;
      past 7-day smoking will be asked to give biochemical verification of smoking status with&#xD;
      saliva cotinine test kits that will be mailed to participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-day point prevalence abstinence at 3 months</measure>
    <time_frame>3 months post baseline</time_frame>
    <description>Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>7-day point prevalence abstinence at 6 months</measure>
    <time_frame>6 months post baseline</time_frame>
    <description>Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>7-day point prevalence abstinence at 12 months</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Reports of no smoking in the 7 days prior to the 12 month assessment. Biochemical verification of abstinence will also be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint</measure>
    <time_frame>3, 6, and 12 months post baseline</time_frame>
    <description>Reduction will be assessed at 3, 6, and 12 month follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quit attempts</measure>
    <time_frame>3, 6, and 12 month post-baseline</time_frame>
    <description>Quit attempt during the follow-up period at 3, 6, and 12 months post-baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health risk behaviors</measure>
    <time_frame>3, 6, and 12 months post baseline</time_frame>
    <description>We will assess prevalence rates of health risk behaviors other than smoking including recent alcohol and illicit drug use, poor sleep quality, sedentary behavior, poor diet, depression, and high risk sexual behavior.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">501</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Facebook intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assignment to private group on Facebook with 3 months of content delivered to the group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Referral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Referral to smokefree.gov website</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Facebook intervention</intervention_name>
    <description>90 days of Facebook messaging, weekly Ask the Doctor sessions</description>
    <arm_group_label>Facebook intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smokefree.gov</intervention_name>
    <description>referral to the NCI Smokefree.gov website</description>
    <arm_group_label>Referral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 18-25 years old&#xD;
&#xD;
          -  english literate&#xD;
&#xD;
          -  have access to Smartphone or computer with camera&#xD;
&#xD;
          -  indicate they go on Facebook &quot;most&quot; (≥ 4) days per week&#xD;
&#xD;
          -  have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette&#xD;
             per day on 3 or more days of the week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not read English&#xD;
&#xD;
          -  younger than 18 or older than 25 years of age&#xD;
&#xD;
          -  do not have access to a Smartphone or computer with a camera&#xD;
&#xD;
          -  only go on Facebook 3 or fewer days a week&#xD;
&#xD;
          -  have smoked less than 100 cigarettes in their lifetime or do not currently smoke at&#xD;
             least 1 cigarette per day on 3 or more days of the week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danielle A Ramo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco Department of Psychiatry</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.</citation>
    <PMID>24575728</PMID>
  </reference>
  <reference>
    <citation>Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.</citation>
    <PMID>26374203</PMID>
  </reference>
  <reference>
    <citation>Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.</citation>
    <PMID>26721211</PMID>
  </reference>
  <results_reference>
    <citation>Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.</citation>
    <PMID>25045624</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>May 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 5, 2017</last_update_submitted>
  <last_update_submitted_qc>May 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco</keyword>
  <keyword>cigarettes</keyword>
  <keyword>cessation</keyword>
  <keyword>intervention</keyword>
  <keyword>young adults</keyword>
  <keyword>Internet</keyword>
  <keyword>social media</keyword>
  <keyword>mobile health</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02207036
org study id: A119678
secondary id: 5K23DA032578
nct id: NCT02207036
lead sponsor: 
collaborator: 
has dmc: No
This randomized clinical trial will test the efficacy of a Facebook intervention based on the
      Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical
      Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).
Participants will be randomized to one of two conditions: (1) a Facebook-delivered
      intervention tailored to readiness to quit smoking; or (2) the control condition (referral to
      the Smokefree.gov website). The intervention will include 12 weeks of Facebook-based messages
      and activities tailored to participants' stage of change.

      Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include
      measures on smoking patterns and thoughts about abstinence. All participants who report no
      past 7-day smoking will be asked to give biochemical verification of smoking status with
      saliva cotinine test kits that will be mailed to participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 7-day point prevalence abstinence at 3 months
time frame: 3 months post baseline
description: Reports of no smoking in the 7 days prior to the 3 month assessment. Biochemical verification of abstinence will also be recorded.
measure: 7-day point prevalence abstinence at 6 months
time frame: 6 months post baseline
description: Reports of no smoking in the 7 days prior to the 6 month assessment. Biochemical verification of abstinence will also be recorded.
measure: 7-day point prevalence abstinence at 12 months
time frame: 12 months post baseline
description: Reports of no smoking in the 7 days prior to the 12 month assessment. Biochemical verification of abstinence will also be recorded.
measure: Reduction in cigarettes smoked by at least 50% between Baseline and each follow-up timepoint
time frame: 3, 6, and 12 months post baseline
description: Reduction will be assessed at 3, 6, and 12 month follow-ups.
measure: Quit attempts
time frame: 3, 6, and 12 month post-baseline
description: Quit attempt during the follow-up period at 3, 6, and 12 months post-baseline.
measure: Health risk behaviors
time frame: 3, 6, and 12 months post baseline
description: We will assess prevalence rates of health risk behaviors other than smoking including recent alcohol and illicit drug use, poor sleep quality, sedentary behavior, poor diet, depression, and high risk sexual behavior.
arm group label: Facebook intervention
arm group type: Experimental
description: Assignment to private group on Facebook with 3 months of content delivered to the group.
arm group label: Referral
arm group type: Active Comparator
description: Referral to smokefree.gov website
intervention type: Behavioral
intervention name: Facebook intervention
description: 90 days of Facebook messaging, weekly Ask the Doctor sessions
arm group label: Facebook intervention
intervention type: Behavioral
intervention name: Smokefree.gov
description: referral to the NCI Smokefree.gov website
arm group label: Referral
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Danielle A Ramo, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Ramo DE, Liu H, Prochaska JJ. A mixed-methods study of young adults' receptivity to using Facebook for smoking cessation: if you build it, will they come? Am J Health Promot. 2015 Mar-Apr;29(4):e126-35. doi: 10.4278/ajhp.130326-QUAL-128. Epub 2014 Feb 27.
PMID: 24575728
citation: Ramo DE, Thrul J, Delucchi KL, Ling PM, Hall SM, Prochaska JJ. The Tobacco Status Project (TSP): Study protocol for a randomized controlled trial of a Facebook smoking cessation intervention for young adults. BMC Public Health. 2015 Sep 15;15:897. doi: 10.1186/s12889-015-2217-0.
PMID: 26374203
citation: Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and Quit Rates of the Tobacco Status Project: A Facebook Smoking Cessation Intervention for Young Adults. J Med Internet Res. 2015 Dec 31;17(12):e291. doi: 10.2196/jmir.5209.
PMID: 26721211
citation: Ramo DE, Rodriguez TM, Chavez K, Sommer MJ, Prochaska JJ. Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned. Internet Interv. 2014 Apr;1(2):58-64. doi: 10.1016/j.invent.2014.05.001.
PMID: 25045624
responsible party type: Sponsor
sharing ipd: No