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

October 24, 2017 updated by: Dr. Wang Man-Ping, The University of Hong Kong

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The Hong Kong Council on Smoking and Health (COSH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
HAR + AWARD + Referral Card + A4 leaflet
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 Names:
  • Higher intensity and personalized active referral (HAR)
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 Names:
  • 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 Names:
  • 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 Names:
  • Brief leaflet on health warning and smoking cessation
Experimental: Group B
LTM + AWARD + Referral Card + A4 leaflet
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 Names:
  • 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 Names:
  • 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 Names:
  • Brief leaflet on health warning and smoking cessation
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 Names:
  • Low-intensity text messaging on using SC services (LTM)
Active Comparator: Group C
Brief advice + 12-page booklet
Behavioral: Brief advice
Very brief, minimal and general smoking cessation advice
Other Names:
  • Brief smoking cessation advice
Other: 12-page booklet
12-page smoking cessation self-help booklet
Other Names:
  • 12-page smoking cessation booklet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
3-month follow-up
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
6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemical validated quit rate
Time Frame: 3-month follow-up
biochemically validated quit rates at 3 month in the three groups
3-month follow-up
Biochemical validated quit rate
Time Frame: 6-month follow-up
biochemically validated quit rates at 6 month in the three groups
6-month follow-up
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
3-month follow-up
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
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 three groups
3-month follow-up
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
6-month follow-up
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
3 and 6 months follow-up
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
3 and 6 months follow-up
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
3 and 6 months follow-up
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
3 and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hong Kong Council on Smoking and Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Man Ping Kelvin Wang, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QTW2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Smoking Cessation

Clinical Trials on HAR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings