Tobacco SmokingQTW2024NCT06451081
Brief Behavioural Economic Intervention for Smoking Cessation
A study testing Brief cessation advice, Opt-out active referral and Behavioral economic mobile messaging in people with Tobacco Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to test the effectiveness of brief behavioural economic intervention in promoting smoking cessation among smokers in the community. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Brief cessation advice, Opt-out active referral and Behavioral economic mobile messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,017 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 years or above
- Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
- Exhaled carbon monoxide level ≥4 parts per million or a positive salivary cotinine test
- Able to communicate in and read Chinese
- Own a smartphone with a mobile instant messaging app installed
Who cannot join
- Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Community sites
Hong Kong
Tzu Tsun Luk
About this study
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2024: a Randomised Controlled Trial of a Brief Behavioural Economic Intervention
The goal of this clinical trial is to test the effectiveness of brief behavioural economic intervention in promoting smoking cessation among smokers in the community.
Read the detailed description
Smoking cessation services are free and effective but underused in Hong Kong. Active referral to smoking cessation services has consistently been found effective in promoting service use and successful quitting as a stand-alone strategy or when combined with other interventions. Participants who received active referral are introduced about the cessation services in Hong Kong and offered connection to the services of their choices. Contacts of participants who agreed to be referred are transferred to the selected cessation providers, who will subsequently contact the participants for further treatment.
The current active referral intervention uses an opt-in approach, where participants are required to actively choose to be connected to the services. By leveraging behavioural economic principles, a simple yet promising strategy to strengthen the active referral intervention is to utilize an "opt-out" approach, where participants are automatically referred to the service unless they actively decline the referral. By making referral to smoking cessation services as the default choice, the investigators aim to increase the uptake of these services and thus improve smoking cessation outcomes. Additionally, mobile messaging informed by behavioural economics principles can serve as nudges to prompt smokers to initiate quitting and utilise cessation services.
The clinical trial aims to test the effectiveness of opt-out referral, with or without behavioural economic-based mobile messaging, compared to opt-in referral, in promoting smoking cessation. The trial will be nested within the 15th "Quit to Win" Smoke-free Community Campaign organised by the Hong Kong Council on Smoking and Health.
- Conditions
- Tobacco Smoking
- Being tested
- Brief cessation advice, Opt-out active referral, Behavioral economic mobile messaging, Opt-in active referral
- Keywords
- cessation, tobacco, behavioural economics, nudge, opt-out
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief cessation adviceBehavioural
Participants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model:
A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again
Opt-out active referralBehavioural
Participants will be automatically referred to a smoking cessation service upon joining the trial, unless they choose to opt out. Contacts of participants will be delivered to a service provider of their choice or based on their living district and preferred treatment modality
Behavioral economic mobile messagingBehavioural
Participants will receive behavioural economics-informed messages via mobile instant messaging for 3 months
Opt-in active referralBehavioural
Participants will be offered a referral to a smoking cessation service. Contacts of participants who opt-in will be delivered to a service provider of their choice
| Study group | Role | What they receive |
|---|---|---|
| Opt-out+ group | Experimental | Brief cessation advice + Opt-out active referral + behavioural economics mobile messaging Receives: Behavioral: Brief cessation advice; Behavioral: Opt-out active referral; Behavioral: Behavioral economic mobile messaging |
| Opt-out group | Experimental | Brief cessation advice + Opt-out active referral Receives: Behavioral: Brief cessation advice; Behavioral: Opt-out active referral |
| Opt-in group | Active comparator | Brief cessation advice + Opt-in active referral Receives: Behavioral: Brief cessation advice; Behavioral: Opt-in active referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated tobacco abstinence
Verified by an exhaled carbon monoxide level of <4 parts per million and a negative salivary cotinine test
Measured: 6 months after randomisation
Secondary outcomes (7)
Biochemically validated tobacco abstinence
Verified by an exhaled carbon monoxide level of <4 parts per million and a negative salivary cotinine test
Measured: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Tobacco abstinence in the past 7 days
Measured: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Tobacco abstinence in the past 7 days
Measured: 6 months after randomisation
Self-reported 24-hour quit attempt
Tobacco abstinence for at least 24 hours
Measured: 3 months after randomisation
Self-reported 24-hour quit attempt
Tobacco abstinence for at least 24 hours
Measured: 6 months after randomisation
Self-reported use of smoking cessation service
Use of any smoking cessation service during the follow-up period
Measured: 3 months after randomisation
Self-reported use of smoking cessation service
Use of any smoking cessation service during the follow-up period
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start15 Jun 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,017 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Responsible party
- Principal investigator, Tzu Tsun Luk, The University of Hong Kong
- Investigators
- Tzu Tsun Luk, PhD, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451081
- Sponsor's protocol ID
- QTW2024
- Acronym
- QTW2024
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29059277
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2024: a Randomised Controlled Trial of a Brief Behavioural Economic Intervention
- ClinicalTrials.gov ID
- NCT06451081
- Acronym / sponsor ID
- QTW2024 / QTW2024
- Conditions
- Tobacco Smoking
- Keywords
- cessation, tobacco, behavioural economics, nudge, opt-out
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,017 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the effectiveness of brief behavioural economic intervention in promoting smoking cessation among smokers in the community.
Detailed description
Smoking cessation services are free and effective but underused in Hong Kong. Active referral to smoking cessation services has consistently been found effective in promoting service use and successful quitting as a stand-alone strategy or when combined with other interventions. Participants who received active referral are introduced about the cessation services in Hong Kong and offered connection to the services of their choices. Contacts of participants who agreed to be referred are transferred to the selected cessation providers, who will subsequently contact the participants for further treatment.
The current active referral intervention uses an opt-in approach, where participants are required to actively choose to be connected to the services. By leveraging behavioural economic principles, a simple yet promising strategy to strengthen the active referral intervention is to utilize an "opt-out" approach, where participants are automatically referred to the service unless they actively decline the referral. By making referral to smoking cessation services as the default choice, the investigators aim to increase the uptake of these services and thus improve smoking cessation outcomes. Additionally, mobile messaging informed by behavioural economics principles can serve as nudges to prompt smokers to initiate quitting and utilise cessation services.
The clinical trial aims to test the effectiveness of opt-out referral, with or without behavioural economic-based mobile messaging, compared to opt-in referral, in promoting smoking cessation. The trial will be nested within the 15th "Quit to Win" Smoke-free Community Campaign organised by the Hong Kong Council on Smoking and Health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opt-out+ group | Experimental | Behavioral: Brief cessation advice, Behavioral: Opt-out active referral, Behavioral: Behavioral economic mobile messagingBrief cessation advice + Opt-out active referral + behavioural economics mobile messaging |
| Opt-out group | Experimental | Behavioral: Brief cessation advice, Behavioral: Opt-out active referralBrief cessation advice + Opt-out active referral |
| Opt-in group | Active comparator | Behavioral: Brief cessation advice, Behavioral: Opt-in active referralBrief cessation advice + Opt-in active referral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents aged 18 years or above
- Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
- Exhaled carbon monoxide level ≥4 parts per million or a positive salivary cotinine test
- Able to communicate in and read Chinese
- Own a smartphone with a mobile instant messaging app installed
Key exclusion criteria (1 listed)
- Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief cessation adviceParticipants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model: A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again | Behavioural | Opt-in group, Opt-out group, Opt-out+ group |
| Opt-out active referralParticipants will be automatically referred to a smoking cessation service upon joining the trial, unless they choose to opt out. Contacts of participants will be delivered to a service provider of their choice or based on their living district and preferred treatment modality | Behavioural | Opt-out group, Opt-out+ group |
| Behavioral economic mobile messagingParticipants will receive behavioural economics-informed messages via mobile instant messaging for 3 months | Behavioural | Opt-out+ group |
| Opt-in active referralParticipants will be offered a referral to a smoking cessation service. Contacts of participants who opt-in will be delivered to a service provider of their choice | Behavioural | Opt-in group |
Primary outcome
Biochemically validated tobacco abstinence
Time frame: 6 months after randomisation
Verified by an exhaled carbon monoxide level of <4 parts per million and a negative salivary cotinine test
7 secondary outcomes
Biochemically validated tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 6 months after randomisation
Self-reported 24-hour quit attempt
Time frame: 3 months after randomisation
Self-reported 24-hour quit attempt
Time frame: 6 months after randomisation
Self-reported use of smoking cessation service
Time frame: 3 months after randomisation
Self-reported use of smoking cessation service
Time frame: 6 months after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 29059277Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu Tsun Luk, PhD, RN principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief cessation advice, Opt-out active referral and Behavioral economic mobile messaging in people with Tobacco Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu Tsun Luk, PhD, RN (39177574, luktt@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated tobacco abstinence (time frame: 6 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.