- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804880
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2016
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
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 / 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
HAR + AWARD + Referral Card + A4 leaflet
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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 Names:
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 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:
The 2-side color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
Other Names:
|
|
Experimental: Group B
LTM + AWARD + Referral Card + A4 leaflet
|
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 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:
The 2-side color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
Other Names:
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 Names:
|
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Active Comparator: Group C
Brief advice + 12-page booklet
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Very brief, minimal and general smoking cessation advice
Other Names:
12-page smoking cessation self-help booklet
Other Names:
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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 month among the three 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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The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 month among the three groups
|
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 three groups
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3-month follow-up
|
|
Biochemical validated quit rate
Time Frame: 6-month follow-up
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biochemically validated quit rates at 6 month in the three groups
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6-month follow-up
|
|
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 three 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 three 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 among the three 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 among the three groups
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6-month 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 2016
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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 2016
|
3 and 6 months follow-up
|
|
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 among three groups
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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 2016
|
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
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
Keywords
Other Study ID Numbers
- QTW2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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