- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03565796
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2018
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2018: a Single-blind Cluster Randomized Controlled Trial on Brief Intervention (AWARD), Active Referral and Financial Incentive for Attending Smoking Cessation (SC) Service to Increase Abstinence
Study Overview
Status
Conditions
Detailed Description
Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking which accounts for over 7,000 deaths per year. 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). 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. 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.
SC services utilization rates are markedly low in Hong Kong. The latest Thematic Household Survey reported that only 3.3% daily smokers had ever used SC services. Among never-used smokers, only 3.1% of them were willing to try the SC services. The previous trial in QTW Contest 2016 depicts a similar pattern. Despite over three quarters of participants (77.0%) in the HAR group had chosen an SC service. Among them, only a small percentage (34.9%) actually used the SC service. Most smokers (65.1%) failed to attend the SC service under the HAR intervention. Consequently, better interventions are needed to extend the reach of SC services and smokers who had chosen an SC service but fail to attend.
The previous trial in QTW Contest 2013 showed a small cash incentive with early notifications increased quit attempt by self-directed help, but it did not increase abstinence and the use of formal cessation aids. Therefore, financial incentive-based SC programme focusing on promoting existing SC services use is warranted.
Therefore, the present study will examine (1) the effectiveness of a combined intervention of face-to-face brief cessation advice (AWARD), active referral of SC service plus financial incentive on encouraging SC services use and (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, a 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Hong Kong
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Hong Kong, Hong Kong, China, 852
- 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 (including reading Chinese)
- Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
- Intent to quit / reduce smoking
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: Group A
Personalized active referral plus financial incentive+ AWARD advice + referral card + warning leaflet+ COSH booklet
|
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 (if the smokers refused to set quit date).
Other Names:
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
Other Names:
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 Names:
A general smoking cessation self-help booklet
Other Names:
Smokers will be introduced to various SC services in Hong Kong and be motivated to use the services.Written consents will be obtained from smokers who are ready to book the service onsite for transfer of their contact telephone numbers to their chosen service providers.
Our research staff will transfer the information to the service providers within a week since the enrollment.Smokers are informed at baseline that they will receive financial incentive (supermarket coupon HK$300) if they attend or use any of the SC services within 3-month.
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Experimental: Group B
AWARD advice + COSH booklet
|
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 (if the smokers refused to set quit date).
Other Names:
A general smoking cessation self-help booklet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical validated quit rate
Time Frame: 3-month follow-up
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The primary outcomes are 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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The primary outcomes are biochemically validated quit rates at 6-month in the two groups
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6-month follow-up
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Secondary 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
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Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups
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3-month follow-up
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Smoking quit rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
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Self-reported 7-day point prevalence (pp) quit rate at 6-month between 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
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6-month follow-up
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Smoking quit attempt change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
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Number of quit attempts at 3-month in the two groups
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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
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Number of quit attempts at 6-month in the two groups
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6-month follow-up
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Use of smoking cessation service
Time Frame: 3 and 6 months follow-up
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Use of smoking cessation at 3 and 6 month follow-up in the two groups
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3 and 6 months follow-up
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Quit rate for all subjects change from baseline at 3- and 6-month follow-up
Time Frame: 3 and 6 months follow-up
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the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2018
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3 and 6 months follow-up
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Reduction rate for all subjects change from baseline at 3- and 6-month follow-up
Time Frame: 3 and 6 months follow-up
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the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2018
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3 and 6 months follow-up
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Use of smoking cessation service for all subjects
Time Frame: 3 and 6 months follow-up
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Use of smoking cessation service for all subjects participating in Quit to Win contest 2018
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3 and 6 months 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
- Weng X, Wu Y, Luk TT, Li WHC, Cheung DYT, Tong HSC, Lai V, Lam TH, Wang MP. Active referral plus a small financial incentive upon cessation services use on smoking abstinence: a community-based, cluster-randomised controlled trial. Lancet Reg Health West Pac. 2021 Jul 5;13:100189. doi: 10.1016/j.lanwpc.2021.100189. eCollection 2021 Aug.
- Weng X, Wang MP, Li HCW, Cheung YTD, Lau CY, Kwong ACS, Lai VWY, Chan SSC, Lam TH. Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial. BMJ Open. 2020 Oct 26;10(10):e038351. doi: 10.1136/bmjopen-2020-038351.
- Luk TT, Weng X, Wu YS, Chan HL, Lau CY, Kwong AC, Lai VW, Lam TH, Wang MP. Association of heated tobacco product use with smoking cessation in Chinese cigarette smokers in Hong Kong: a prospective study. Tob Control. 2021 Nov;30(6):653-659. doi: 10.1136/tobaccocontrol-2020-055857. Epub 2020 Sep 10.
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QTW 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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