- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02539875
Promoting Smoking Cessation in the Community Via QTW 2015
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2015: a Randomized Controlled Trial on Brief Intervention (AWARD Model) and Active Referral to Smoking Cessation Services
Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers 10.8% (Census and Statistics Department, 2013) 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, 2008).
Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult daily smokers who had never used smoking cessation services (Census and Statistics Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing services mostly require self-initiation to seek the services but smokers general lack the will power of initiation. Active referral will help overcome the barriers of self-initiation. There is preliminary evidence that active referral of smokers to smoking cessation hotline services may increase likelihood of smoking abstinence at 12-month follow-up compared with no active referrals (Borland et al., 2008). A recent study has also reported that individuals who used the community-based referral were also more likely to quit than those who did not (43.6% vs 15.3%, P<0.001) (Haas et al., 2015).
Therefore, the present study will examine (1) effectiveness of the active referral and AWARD approaches, (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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- The Hong Kong Council on Smoking and Health (COSH)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Exclusion Criteria:
- Smokers who have difficulties (either physical or cognitive condition) to communicate
- Currently following other smoking cessation programs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AWARD, Brief leaflet, Referral leaflet, active referral
AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit as soon as possible and not later than a quit date (which will qualify them for the QTW prizes), Refer smokers to smoking cessation services, and Do it again: to repeat the intervention.
Brief innovative leaflet on health warning and smoking cessation.
A 2-side color printed A4 leaflet will be designed to systematically cover the most important messages to motivate smoking cessation.
A 2-side color printed A4 referral leaflet will be used for motivate and assist the smokers to use the smoking cessation services.
the smokers will be active refer to various smoking cessation services in Hong Kong (using the referral leaflet) and motivate the smokers to use the smoking cessation services.
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Use AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices interventions to achieve smoking abstinence
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|
Experimental: AWARD, Brief leaflet
AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit as soon as possible and not later than a quit date (which will qualify them for the QTW prizes), Refer smokers to smoking cessation services, and Do it again: to repeat the intervention.
Brief innovative leaflet on health warning and smoking cessation.
A 2-side color printed A4 leaflet will be designed to systematically cover the most important messages to motivate smoking cessation.
|
Use AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices interventions to achieve smoking abstinence
|
|
Active Comparator: Smoking cessation booklet, general advices
Participants will receive minimal intervention, including: (1) the 12-page smoking cessation booklet (provided by COSH); (2) very brief, minimal and general smoking cessation advice include: "Please quit smoking for improving health and save money", "Please refer to the booklet for the details about smoking cessation" and "Please call us if you have any enquiry".
|
Use AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices interventions to achieve smoking abstinence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 and 6 months among the two groups
|
3-month follow-up
|
|
smoking quit rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
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The primary outcomes are self-reported 7-day point prevalence (pp) quit rate
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6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemical validated quit rate
Time Frame: 3-month follow-up
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biochemically validated quit rates at 3 month in the two groups
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3-month follow-up
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Biochemical validated quit rate
Time Frame: 6-month follow-up
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biochemically validated quit rates at 6 month in the two groups
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6-month follow-up
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|
Smoking reduction rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
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rate of smoking reduction by at least half of baseline amount in the two groups
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3-month follow-up
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Smoking reduction rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
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rate of smoking reduction by at least half of baseline amount in the two groups
|
6-month follow-up
|
|
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 two groups
|
3-month follow-up
|
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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 two groups
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6-month follow-up
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quit rate for all subjects change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
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the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
|
3-month follow-up
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Reduction rate for all subjects change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
|
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
|
3-month follow-up
|
|
quit rate for all subjects change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
|
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
|
6-month follow-up
|
|
Reduction rate for all subjects change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
|
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
|
6-month follow-up
|
|
quit rate for all subjects change from baseline at 12-month follow-up
Time Frame: 12-month follow-up
|
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
|
12-month follow-up
|
|
Reduction rate for all subjects change from baseline at 12-month follow-up
Time Frame: 12-month follow-up
|
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
|
12-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Man Ping Kelvin Wang, PhD, The University of Hong Kong
Publications and helpful links
General Publications
- Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.
- Suen YN, Wang MP, Li WH, Kwong AC, Lai VW, Chan SS, Lam TH. Brief advice and active referral for smoking cessation services among community smokers: a study protocol for randomized controlled trial. BMC Public Health. 2016 May 11;16:387. doi: 10.1186/s12889-016-3084-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QTW2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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