<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/NCT02188433</url>
  </required_header>
  <id_info>
    <org_study_id>QTW2014</org_study_id>
    <nct_id>NCT02188433</nct_id>
  </id_info>
  <brief_title>Promoting Smoking Cessation in the Community Via QTW 2014</brief_title>
  <official_title>Building Capacity and Promoting Smoking Cessation in the Community Via Quit to Win Contest 2014: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hong Kong Council on Smoking and Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although smoking prevalence is decreasing in Hong Kong, there are still 645,000 daily smokers&#xD;
      10.7% ( Thematic Household Survey 2012) and half will be killed by smoking (Lam ,2012) which&#xD;
      accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, &amp; Peto, 2001). Smoking also&#xD;
      accounts for a large amount of medical cost, long-term care and productivity loss of US$688&#xD;
      million (0.6% Hong Kong GDP) (McGhee et al., 2006) (Census &amp; Statistics Department (Hong Kong&#xD;
      Special Administrative Region government), 2001). Smoking is a highly addictive behavior and&#xD;
      it is difficult for smokers with strong nicotine dependence to quit without assistance. On&#xD;
      the other hand, reaching and helping the many smokers who have no intention to quit is a&#xD;
      challenge, because they are unlikely to seek professional help from smoking cessation&#xD;
      services. The Quit and Win programme provides an opportunity to reach and encourage a large&#xD;
      group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits&#xD;
      that smokers participating in the contest will have higher motivation to quit with incentives&#xD;
      and better social support (Cahill &amp; Petera, 2011). Studies have found that such quitting&#xD;
      contests or incentive programs appeared to reach a large number of smokers and demonstrated a&#xD;
      significantly higher quit rate for the quit and win group than for the control group (Cahill&#xD;
      &amp; Rafael, 2008).&#xD;
&#xD;
      The Quit to Win Contest in 2014 and the study's interventions using cut down to quit approach&#xD;
      are theoretically based on the Health Action Process Approach ( HAPA) for the intervention&#xD;
      group (Schwarzer, 2008). The HAPA suggests that one's intention of behavior change can be&#xD;
      fostered by knowing that the new behavior has positive outcomes as opposed to the negative&#xD;
      outcomes that accompany the current behavior; and planning (action planning and coping&#xD;
      planning) which serves as an operative mediator between intentions and behavior. Using&#xD;
      gradual cut down approach on smoking cessation will probably increase smoker's self-efficacy&#xD;
      on smoking cessation as the process could be achieved at the smoker's own perceived pace&#xD;
      without placing too much pressure on themselves but with greater control of self in the&#xD;
      cessation process. This was supported by the evidence that smoking reduction approach led to&#xD;
      a greater self-efficacy to resist smoking and increased subsequent quitting (Broms, Korhonen,&#xD;
      &amp; Kaprio, 2008). Most importantly, reducing cigarette consumption will lower the nicotine&#xD;
      dependence which is associated with later abstinence (Hughes et al., 2004). On the other&#xD;
      hand, quitting immediately will have a less sense of control and may be subjected to relapse&#xD;
      thus lower the self-efficacy on quitting.&#xD;
&#xD;
      Therefore, the present study will examine (1) effectiveness of the cut down to quit (CDTQ)&#xD;
      and quit immediately (QI) approaches; (2) explore the use of Community-Based Participatory&#xD;
      Research (CBPR) model to build capacity and to engage community partners in taking on this&#xD;
      important public health issue for sustainability in the community. In addition, process&#xD;
      evaluation will be conducted to assess the effectiveness of the recruitment activity and how&#xD;
      it is linked with the overall program outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">July 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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>smoking quit rate</measure>
    <time_frame>3-, 6- and 12-month follow-up</time_frame>
    <description>The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 and 6 months among the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical validated quit rate</measure>
    <time_frame>3-, 6- and 12-month follow-up</time_frame>
    <description>biochemically validated quit rates at 3 and 6 months in the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking reduction rate</measure>
    <time_frame>3-, 6- and 12-month follow-up</time_frame>
    <description>rate of smoking reduction by at least half of baseline amount in the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking quit attempt</measure>
    <time_frame>3-, 6- and 12-month follow-up</time_frame>
    <description>number of quit attempts at 3 and 6 months among the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quit rate and reduction rate for all subjects</measure>
    <time_frame>3-, 6- and 12-month follow-up</time_frame>
    <description>the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2014</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1307</enrollment>
  <condition>Smoking Cessation Intervention</condition>
  <arm_group>
    <arm_group_label>Cut down to quit (CDTQ)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For those subjects who claim that they cannot quit smoking ≤7 days, they will receive a leaflet (i.e. include a roadmap of smoking reduction strategy) plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit as quitting can greatly reduce risks, and participants will be advised to cut down cigarette consumption at their own pace, but the process should not exceed 3 months. (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention and encourage smokers who fail to quit or relapse to reduce again during each telephone follow-up.&#xD;
For the subjects have intention to quit smoking ≤7 days, the investigator will follow-up them after a week. For those who report quitted, they will be followed up as other participants. However, if they report failed to quit, they will receive the same interventions and will be followed-up as other participants in the experimental group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quit Immediately (QI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>QI group subjects will receive a smoking cessation booklet (provided by COSH) plus brief intervention using AWARD model similar to CDTQ group. For the subsequent telephone follow-up repeat the health warning that 'one in two smokers will be killed by smoking' and encourage smokers who fail to quit or relapse to try again.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quit immediately (QI) / cut down to quit (CDTQ)</intervention_name>
    <description>Use quit immediately (QI) or cut down to quit (CDTQ) interventions to achieve smoking abstinence</description>
    <arm_group_label>Cut down to quit (CDTQ)</arm_group_label>
    <arm_group_label>Quit Immediately (QI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong residents aged 18 or above&#xD;
&#xD;
          -  Smoke at least 1 cigarette per day in the past 3 months&#xD;
&#xD;
          -  Able to communicate in Cantonese&#xD;
&#xD;
          -  Exhaled carbon monoxide (CO) of 4 ppm or above, assessed by a validated CO smokerlyzer&#xD;
&#xD;
          -  Have Intention to quit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers who have difficulties (either physical or cognitive condition) to communicate&#xD;
&#xD;
          -  Currently following other smoking cessation programs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Man Ping Kelvin Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hong Kong Council on Smoking and Health (COSH)</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Effectiveness of quit immediately (QI) and cut down to quit (CDTQ) interventions in achieving smoking abstinence</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/NCT02188433
org study id: QTW2014
nct id: NCT02188433
lead sponsor: 
collaborator: 
has dmc: Yes
Although smoking prevalence is decreasing in Hong Kong, there are still 645,000 daily smokers
      10.7% ( Thematic Household Survey 2012) and half will be killed by smoking (Lam ,2012) which
      accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, & Peto, 2001). Smoking also
      accounts for a large amount of medical cost, long-term care and productivity loss of US$688
      million (0.6% Hong Kong GDP) (McGhee et al., 2006) (Census & Statistics Department (Hong Kong
      Special Administrative Region government), 2001). Smoking is a highly addictive behavior and
      it is difficult for smokers with strong nicotine dependence to quit without assistance. On
      the other hand, reaching and helping the many smokers who have no intention to quit is a
      challenge, because they are unlikely to seek professional help from smoking cessation
      services. The Quit and Win programme provides an opportunity to reach and encourage a large
      group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits
      that smokers participating in the contest will have higher motivation to quit with incentives
      and better social support (Cahill & Petera, 2011). Studies have found that such quitting
      contests or incentive programs appeared to reach a large number of smokers and demonstrated a
      significantly higher quit rate for the quit and win group than for the control group (Cahill
      & Rafael, 2008).

      The Quit to Win Contest in 2014 and the study's interventions using cut down to quit approach
      are theoretically based on the Health Action Process Approach ( HAPA) for the intervention
      group (Schwarzer, 2008). The HAPA suggests that one's intention of behavior change can be
      fostered by knowing that the new behavior has positive outcomes as opposed to the negative
      outcomes that accompany the current behavior; and planning (action planning and coping
      planning) which serves as an operative mediator between intentions and behavior. Using
      gradual cut down approach on smoking cessation will probably increase smoker's self-efficacy
      on smoking cessation as the process could be achieved at the smoker's own perceived pace
      without placing too much pressure on themselves but with greater control of self in the
      cessation process. This was supported by the evidence that smoking reduction approach led to
      a greater self-efficacy to resist smoking and increased subsequent quitting (Broms, Korhonen,
      & Kaprio, 2008). Most importantly, reducing cigarette consumption will lower the nicotine
      dependence which is associated with later abstinence (Hughes et al., 2004). On the other
      hand, quitting immediately will have a less sense of control and may be subjected to relapse
      thus lower the self-efficacy on quitting.

      Therefore, the present study will examine (1) effectiveness of the cut down to quit (CDTQ)
      and quit immediately (QI) approaches; (2) explore the use of Community-Based Participatory
      Research (CBPR) model to build capacity and to engage community partners in taking on this
      important public health issue for sustainability in the community. In addition, process
      evaluation will be conducted to assess the effectiveness of the recruitment activity and how
      it is linked with the overall program outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: smoking quit rate
time frame: 3-, 6- and 12-month follow-up
description: The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 and 6 months among the two groups
measure: Biochemical validated quit rate
time frame: 3-, 6- and 12-month follow-up
description: biochemically validated quit rates at 3 and 6 months in the two groups
measure: Smoking reduction rate
time frame: 3-, 6- and 12-month follow-up
description: rate of smoking reduction by at least half of baseline amount in the two groups
measure: Smoking quit attempt
time frame: 3-, 6- and 12-month follow-up
description: number of quit attempts at 3 and 6 months among the two groups
measure: quit rate and reduction rate for all subjects
time frame: 3-, 6- and 12-month follow-up
description: the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2014
arm group label: Cut down to quit (CDTQ)
arm group type: Experimental
description: For those subjects who claim that they cannot quit smoking ≤7 days, they will receive a leaflet (i.e. include a roadmap of smoking reduction strategy) plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit as quitting can greatly reduce risks, and participants will be advised to cut down cigarette consumption at their own pace, but the process should not exceed 3 months. (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention and encourage smokers who fail to quit or relapse to reduce again during each telephone follow-up.
For the subjects have intention to quit smoking ≤7 days, the investigator will follow-up them after a week. For those who report quitted, they will be followed up as other participants. However, if they report failed to quit, they will receive the same interventions and will be followed-up as other participants in the experimental group.
arm group label: Quit Immediately (QI)
arm group type: Active Comparator
description: QI group subjects will receive a smoking cessation booklet (provided by COSH) plus brief intervention using AWARD model similar to CDTQ group. For the subsequent telephone follow-up repeat the health warning that 'one in two smokers will be killed by smoking' and encourage smokers who fail to quit or relapse to try again.
intervention type: Behavioral
intervention name: Quit immediately (QI) / cut down to quit (CDTQ)
description: Use quit immediately (QI) or cut down to quit (CDTQ) interventions to achieve smoking abstinence
arm group label: Cut down to quit (CDTQ)
arm group label: Quit Immediately (QI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Man Ping Kelvin Wang, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: China
responsible party type: Sponsor