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Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2016

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ClinicalTrials.gov Identifier: NCT02804880
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Hong Kong Council on Smoking and Health
Information provided by (Responsible Party):
Dr. Wang Man-Ping, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • smoking quit rate change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 month among the three groups
  • smoking quit rate change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 month among the three groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • Biochemical validated quit rate [ Time Frame: 3-month follow-up ]
    biochemically validated quit rates at 3 month in the three groups
  • Biochemical validated quit rate [ Time Frame: 6-month follow-up ]
    biochemically validated quit rates at 6 month in the three groups
  • Smoking reduction rate change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    rate of smoking reduction by at least half of baseline amount in the three groups
  • Smoking reduction rate change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    rate of smoking reduction by at least half of baseline amount in the three groups
  • Smoking quit attempt change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    number of quit attempts at 3 month among the three groups
  • Smoking quit attempt change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    number of quit attempts at 6 month among the three groups
  • quit rate for all subjects change from baseline at 3- and 6-month follow-up [ Time Frame: 3 and 6 months follow-up ]
    the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2016
  • Reduction rate for all subjects change from baseline at 3- and 6-month follow-up [ Time Frame: 3 and 6 months follow-up ]
    the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2016
  • Use of smoking cessation service [ Time Frame: 3 and 6 months follow-up ]
    use of smoking cessation at 3 and 6 month follow-up among three groups
  • Use of smoking cessation service for all subjects [ Time Frame: 3 and 6 months follow-up ]
    Use of smoking cessation service for all subjects participating in Quit to Win contest 2016
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • Biochemical validated quit rate [ Time Frame: 3-month follow-up ]
    biochemically validated quit rates at 3 month in the three groups
  • Biochemical validated quit rate [ Time Frame: 6-month follow-up ]
    biochemically validated quit rates at 6 month in the three groups
  • Smoking reduction rate change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    rate of smoking reduction by at least half of baseline amount in the three groups
  • Smoking reduction rate change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    rate of smoking reduction by at least half of baseline amount in the three groups
  • Smoking quit attempt change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    number of quit attempts at 3 month among the three groups
  • Smoking quit attempt change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    number of quit attempts at 6 month among the three groups
  • quit rate for all subjects change from baseline at 3- and 6-month follow-up [ Time Frame: 3 and 6 months follow-up ]
    the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2016
  • Reduction rate for all subjects change from baseline at 3-month follow-up [ Time Frame: 3 and 6 months follow-up ]
    the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2016
  • Use of smoking cessation service [ Time Frame: 3 and 6 months follow-up ]
    use of smoking cessation at 3 and 6 month follow-up among three groups
  • Use of smoking cessation service for all subjects [ Time Frame: 3 and 6 months follow-up ]
    Use of smoking cessation service for all subjects participating in Quit to Win contest 2016
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2016
Official Title  ICMJE Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2016: a Single-blind Cluster Randomized Controlled Trial on High Intensity Active Referral and Simple Text Messaging to Achieve Abstinence
Brief Summary The present study will examine (1) the effectiveness of personalised active referral to smoking cessation (SC) services and text messaging on encouraging SC services (2) explore the use of 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.
Detailed Description

Although smoking prevalence is decreasing in Hong Kong, there are still 641,300 daily smokers (10.5%; Census and Statistics Department, 2015) 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) (Census & Statistics Department, 2001; McGhee et al., 2006) . 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 & Perera, 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 & Perera, 2015).

Smoking cessation services in Hong Kong are under-used with most of the adult daily smokers (79.6%) who had never used smoking cessation services (Census and Statistics Department, 2015). Among these smokers, only 2.4% were willing to use the services. Our previous RCT in previous QTW Contest 2015 evaluated the effects of low-intensity active referral (LAR) vs. very brief general SC advice (VBA) on quitting. LAR included onsite AWARD counselling and collection of smokers' personal contact information for SC services providers to connect with the smokers. Findings at 3-month follow-up of this RCT suggested the LAR intervention resulted in significantly higher self-reported quit rate than VBA in the control group (18.7% vs 14.0%. P<0.001).

It is warranted to evaluate if a higher intensity active referral (HAR) and/or text messaging on encouraging SC services use can achieve even higher quit rate when compared with only VBA is given in the control group. Noted the use of text-messaging is the cheaper method than HAR. By using the same design of control group in QTW 2015, we can combine and compare the 2 years QTW intervention of HAR, LAR and text-messaging using network meta-analysis. This will contribute to finding out a more cost-effective way to increase the quit rate through using SC services.

Therefore, the present study will examine (1) the effectiveness of personalised active referral to smoking cessation (SC) services and text messaging on encouraging SC services (2) explore the use of 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Behavioral: HAR
    Smokers will be introduced to various smoking cessation (SC) services in Hong Kong (using the referral card) and be motivated to use the services. Field research staff will assist on-site booking SC services for smokers. Tailored messages, including: harm of smoking, benefit of smoking cessation, importance of adherence to smoking cessation appointment and encouragement on abstinence will be sent via instant messaging (IM) services (e.g. WhatsApp, WeChat) to smokers after initial contact.
    Other Name: Higher intensity and personalized active referral (HAR)
  • Behavioral: LTM
    Fix-schedule SMS messages will be sent to encourage them to book the smoking cessation services appointment. Smokers are required to book the SC appointments by themselves.
    Other Name: Low-intensity text messaging on using SC services (LTM)
  • Behavioral: AWARD
    Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again: to repeat the intervention during tel. follow-ups.
    Other Name: Ask, Warn, Advise, Refer, Do-it-again
  • Other: Referral card
    The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.
    Other Name: Smoking Cessation Service Card
  • Other: A4 leaflet
    The 2-side color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
    Other Name: Brief leaflet on health warning and smoking cessation
  • Behavioral: Brief advice
    Very brief, minimal and general smoking cessation advice
    Other Name: Brief smoking cessation advice
  • Other: 12-page booklet
    12-page smoking cessation self-help booklet
    Other Name: 12-page smoking cessation booklet
Study Arms  ICMJE
  • Experimental: Group A
    HAR + AWARD + Referral Card + A4 leaflet
    Interventions:
    • Behavioral: HAR
    • Behavioral: AWARD
    • Other: Referral card
    • Other: A4 leaflet
  • Experimental: Group B
    LTM + AWARD + Referral Card + A4 leaflet
    Interventions:
    • Behavioral: LTM
    • Behavioral: AWARD
    • Other: Referral card
    • Other: A4 leaflet
  • Active Comparator: Group C
    Brief advice + 12-page booklet
    Interventions:
    • Behavioral: Brief advice
    • Other: 12-page booklet
Publications * Weng X, Wang MP, Suen YN, Li WHC, Wu Y, Cheung DYT, Kwong ACS, Lai VWY, Chan SSC, Lam TH. Comparing different intensities of active referral to smoking cessation services in promoting smoking cessation among community smokers: a study protocol of a cluster randomized controlled trial. BMC Public Health. 2018 Jul 4;18(1):830. doi: 10.1186/s12889-018-5782-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 16, 2016)
1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Hong Kong residents aged 18 or above

  • Smoke at least 1 cigarette per day in the past 3 months
  • Able to communicate in Cantonese
  • Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
  • Have Intention to quit / reduce smoking

Exclusion Criteria:

  • Smokers who have difficulties (either physical or cognitive condition) to communicate
  • Currently following other smoking cessation programs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804880
Other Study ID Numbers  ICMJE QTW2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Wang Man-Ping, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Hong Kong Council on Smoking and Health
Investigators  ICMJE
Principal Investigator: Man Ping Kelvin Wang, PhD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP