<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/NCT01734421</url>
  </required_header>
  <id_info>
    <org_study_id>PI12/01977</org_study_id>
    <nct_id>NCT01734421</nct_id>
  </id_info>
  <brief_title>Efficacy of a Mobile Application in the Smoking Cessation Among Young People</brief_title>
  <acronym>TOBB_STOP</acronym>
  <official_title>Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Preventive Services and Health Promotion Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <brief_summary>
    <textblock>
      AIM: To assess the efficacy of an intervention based on the specific design and&#xD;
      implementation of a mobile application (APP) in order to reduce the prevalence of smoking&#xD;
      consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical&#xD;
      trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat&#xD;
      analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18&#xD;
      to 30 years consulting for any reason to PHCC and who provided written informed consent to&#xD;
      participate in the trial.&#xD;
&#xD;
      INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline&#xD;
      smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME&#xD;
      MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of&#xD;
      less or iqual 10 parts per million in each control.&#xD;
&#xD;
      RESULTS: The application of a smoking cessation intervention with a mobile APPs application&#xD;
      will improve the smoking cessation success rate in smokers, besides of their intention or not&#xD;
      to give up smoking at baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking cessation</measure>
    <time_frame>Change in smoking status from baseline at 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">604</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Habitual deshabituation in the control group following the guidelines of the primary health care institution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cell phone Aplication for Smarth Phone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cell phone 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cell phone Aplication for Smarth Phone</intervention_name>
    <arm_group_label>Cell phone Aplication for Smarth Phone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant between 18 t0 30 years old smoking 10 or more cigarretes at day&#xD;
&#xD;
          -  To have a smarthphone (Android, ios Ihpone, ios Ipad)&#xD;
&#xD;
          -  Normal and high motivation for smocking cessation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have other addictions&#xD;
&#xD;
          -  Participants with Blackberry smarthphone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Empar Valdivieso López, Nurse</last_name>
    <phone>+34675783477</phone>
    <email>evaldivieso.tarte.ics@gencat.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gemma Flores Mateo, PhD</last_name>
    <phone>+34626136232</phone>
    <email>gflores@idiapjgol.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jordi Gol i Gurina Foundation</name>
      <address>
        <city>Barcelona</city>
        <zip>08007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Gemma Flores Mateo, PhD</last_name>
      <phone>+34626136232</phone>
      <email>gflores@idiapjgol.org</email>
    </contact>
    <investigator>
      <last_name>Empar Valdivieso López, Nurse</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Araceli Valverde Trillo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gemma Flores Mateo, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cristina Rey Reñones, Nurse</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juan Domingo Molina Gomez, Bsc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Primary health care</keyword>
  <keyword>Young people</keyword>
  <keyword>Cellular phone</keyword>
  <!-- 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/NCT01734421
org study id: PI12/01977
nct id: NCT01734421
lead sponsor: 
collaborator: 
AIM: To assess the efficacy of an intervention based on the specific design and
      implementation of a mobile application (APP) in order to reduce the prevalence of smoking
      consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical
      trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat
      analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18
      to 30 years consulting for any reason to PHCC and who provided written informed consent to
      participate in the trial.

      INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline
      smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME
      MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of
      less or iqual 10 parts per million in each control.

      RESULTS: The application of a smoking cessation intervention with a mobile APPs application
      will improve the smoking cessation success rate in smokers, besides of their intention or not
      to give up smoking at baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Smoking cessation
time frame: Change in smoking status from baseline at 6 months
arm group label: Control group
arm group type: Other
description: Habitual deshabituation in the control group following the guidelines of the primary health care institution.
arm group label: Cell phone Aplication for Smarth Phone
arm group type: Active Comparator
description: Cell phone 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application
intervention type: Other
intervention name: Control group
description: 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation
arm group label: Control group
intervention type: Device
intervention name: Cell phone Aplication for Smarth Phone
arm group label: Cell phone Aplication for Smarth Phone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Empar Valdivieso López, Nurse
phone: +34675783477
email: evaldivieso.tarte.ics@gencat.cat
last name: Gemma Flores Mateo, PhD
phone: +34626136232
email: gflores@idiapjgol.org
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor