<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/NCT02968199</url>
  </required_header>
  <id_info>
    <org_study_id>Smoking_1</org_study_id>
    <nct_id>NCT02968199</nct_id>
  </id_info>
  <brief_title>Building a Community-based Network to Promote Smoking Cessation</brief_title>
  <official_title>Development of a Community-based Network to Promote Smoking Cessation Among Female Smokers in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study describes the development of a community-based network to promote smoking&#xD;
      cessation among female smokers in Hong Kong.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is growing concern about the use of tobacco among women in Hong Kong. Nevertheless,&#xD;
      nearly all of them reported that they had not attended smoking cessation services provided by&#xD;
      the government and other organizations, of which only 6.7% indicated that they would like to&#xD;
      attend, demonstrating the need for population-based smoking cessation interventions targeting&#xD;
      female smokers in Hong Kong. In response to the increased number of female smokers and their&#xD;
      low usage rates of smoking cessation services, the first smoking cessation hotline for female&#xD;
      smokers in Hong Kong was established in 2006 by the University of Hong Kong. The aim of this&#xD;
      study was to describe the development of a community-based network to promote the smoking&#xD;
      cessation hotline among female smokers in Hong Kong.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2006</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The study was not a randomized controlled trial. Participants and outcome assessors were not blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>self-reported 7-day point prevalence of abstinence</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>self-reported reduction of ≥ 50% in cigarette consumption</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of self-efficacy at baseline</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of self-efficacy at six months</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">457</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Referred women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A brief intervention based on the'5 A' model developed by the Agency for Health Care Policy and Research in the United States.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A brief intervention</intervention_name>
    <description>The content of the intervention includes: (1) asking about tobacco use; (2) advising cessation; (3) assessing willingness to quit; (4) assisting in the attempt to quit; and (5) arranging follow-up.</description>
    <arm_group_label>Referred women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female Hong Kong Chinese current smokers&#xD;
&#xD;
          -  Aged 15 years or above&#xD;
&#xD;
          -  Able to speak and understand Cantonese&#xD;
&#xD;
          -  Willing to receive face-to-face or telephone counseling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who were participating in other smoking cessation programs or services&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William, Ho Cheung LI, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong SAR</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02968199
org study id: Smoking_1
nct id: NCT02968199
lead sponsor: 
has dmc: Yes
This study describes the development of a community-based network to promote smoking
      cessation among female smokers in Hong Kong.
There is growing concern about the use of tobacco among women in Hong Kong. Nevertheless,
      nearly all of them reported that they had not attended smoking cessation services provided by
      the government and other organizations, of which only 6.7% indicated that they would like to
      attend, demonstrating the need for population-based smoking cessation interventions targeting
      female smokers in Hong Kong. In response to the increased number of female smokers and their
      low usage rates of smoking cessation services, the first smoking cessation hotline for female
      smokers in Hong Kong was established in 2006 by the University of Hong Kong. The aim of this
      study was to describe the development of a community-based network to promote the smoking
      cessation hotline among female smokers in Hong Kong.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
masking description: The study was not a randomized controlled trial. Participants and outcome assessors were not blinded.
measure: self-reported 7-day point prevalence of abstinence
time frame: 6 months
measure: self-reported reduction of ≥ 50% in cigarette consumption
time frame: 6 months
measure: Levels of self-efficacy at baseline
time frame: baseline
measure: Levels of self-efficacy at six months
time frame: six months
arm group label: Referred women
arm group type: Experimental
description: A brief intervention based on the'5 A' model developed by the Agency for Health Care Policy and Research in the United States.
intervention type: Behavioral
intervention name: A brief intervention
description: The content of the intervention includes: (1) asking about tobacco use; (2) advising cessation; (3) assessing willingness to quit; (4) assisting in the attempt to quit; and (5) arranging follow-up.
arm group label: Referred women
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: William, Ho Cheung LI, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No