Smoking CessationQTW2026NCT07649044
Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Engagement-Focused GenAI-based Chatbot for Real-Time Smoking Cessation Support
A study testing AWARD advice, Brief leaflet on health warning and smoking cessation and Referral card in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this trial is to learn if chatbot-based instant messaging works to help smoking cessation in general adult smokers. It will also learn about the experience, attitude, and perception of using an LLM-based chatbot. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- AWARD advice, Brief leaflet on health warning and smoking cessation and Referral card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 998 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 years or above
- Smoke at least one cigarette (including heated tobacco products) per day or use an e-cigarette daily in the preceding 3 months
- Able to communicate in Cantonese (including reading and writing Chinese)
- Saliva cotinine level ≥30 ng/mL
- Intention to quit or reduce smoking
- Have WhatsApp installed
- Able to use WhatsApp for communication
Who cannot join
- Smokers who have communication barriers (either physical or cognitive)
- Smokers who are currently participating in other smoking cessation programs or services
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Hong Kong Council on Smoking and Health (COSH)
Hong Kong, Hong Kong, 999077
Man Ping Wang, PhD, +852 3917 6636, mpwang@hku.hk
Yilan Wu, +852 56497578, visspalan@connect.hku.hk
About this study
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Real-time Smoking Cessation Instant Messaging Support Using a Engagement-Focused Large Language Model (LLM)-Based Chatbot
The goal of this trial is to learn if chatbot-based instant messaging works to help smoking cessation in general adult smokers. It will also learn about the experience, attitude, and perception of using an LLM-based chatbot. The main questions it aims to answer are:
- Will an engagement-focused LLM-based chatbot smoking cessation intervention have a non-inferior validated abstinence rate than the control group?
- Will an LLM-based chatbot smoking cessation intervention have a non-inferior self-reported abstinence rate, smoking reduction rate, and smoking cessation services use rate than the control group?
Read more
Researchers will compare an LLM-based chatbot smoking-cessation intervention to a human-led instant messaging support group (brief advice based on AWARD and personalised active referral) to determine whether chatbot-based instant messaging support promotes smoking cessation.
Participants in the intervention group will receive:
- AWARD advice
- Personalised active referral
- 12 weeks of chatbot-based instant messaging support (via WhatsApp)
Read the detailed description
Although smoking prevalence in Hong Kong has declined to 9.1% in 2023, achieving the government's target of 7.8% by 2025 remains a major public health challenge. Unassisted "cold turkey" quitting has a long-term success rate of less than 5%, whereas evidence-based behavioural and pharmacological interventions can raise success rates to approximately 20% or higher. However, existing cessation services in Hong Kong face a critical utilisation gap: only 17.5% of smokers have engaged with professional services, and merely 23% have used nicotine replacement therapy. This underutilisation suggests that traditional human-resource-intensive models may lack accessibility, scalability, and local appeal. Generative AI, particularly large language models, offers a transformative solution by delivering consistent, scalable, and personalised support. In the 2025 "Quit to Win" round, investigators integrated an LLM-based chatbot via WhatsApp and received positive qualitative feedback. Yet quantitative analysis revealed a sharp decline in engagement, with weekly participation dropping from 32% in week 1 to 14% by week 12, indicating that conversational ability alone does not guarantee sustained user commitment. To address this implementation gap, investigators have developed an engagement-focused GenAI companion that incorporates structured onboarding, context-aware personalisation, multimodal (text/audio) input, empathetic support, habit-aligned reminders, localised humour, and gamified features such as success stories and knowledge quizzes. Therefore, the current study aims to test, via a two-arm non-inferiority randomised controlled trial, the effectiveness of a comprehensive intervention combining brief cessation advice (AWARD), personalised active referral, and this engagement-enhanced GenAI chatbot support compared with human-led instant messaging counselling among current smokers who join the Quit to Win Contest across all 18 districts of Hong Kong.
- Conditions
- Smoking Cessation
- Being tested
- AWARD advice, Brief leaflet on health warning and smoking cessation, Referral card, Self-help smoking cessation booklet, Personalized active referral
- Keywords
- Large-language model, Chatbot, Smoking cessation, Digital health, Engagement
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARD adviceBehavioural
A brief (30-60 seconds) face-to-face or remote smoking cessation advice delivered using the validated AWARD model: Ask about smoking history; Warn about high health risks (accompanied by a health warning leaflet); Advise quitting as soon as possible and setting a quit date (to qualify for contest prizes); Refer to smoking cessation services using a referral card; Do it again - repeat the intervention at each follow-up, encouraging re-quitting after relapse or relapse prevention after success.
Brief leaflet on health warning and smoking cessationBehavioural
A two-sided, colour-printed A4 leaflet covering: (1) absolute risk of death from smoking; (2) full list of diseases caused by active and second-hand smoking; (3) ten pictorial warnings of health consequences on one page for maximum impact; (4) benefits of smoking cessation; and (5) simple encouraging messages to quit.
Referral cardBehavioural
A three-folded card containing brief information and highlights of existing smoking cessation services in Hong Kong, contact methods, motivational messages, and strong supporting slogans.
Self-help smoking cessation bookletBehavioural
A generic booklet provided covering: benefits of quitting, smoking-related diseases, methods to quit, how to handle withdrawal symptoms, a quitting declaration, and other practical tips.
Personalized active referralBehavioural
Smokers will be introduced to various SC services in Hong Kong (via the referral card) and motivated to use them. Well-trained SC ambassadors will assist smokers in choosing their favourite or most convenient type of service. Research staff will assist participants in booking or re-booking the SC services at the 1- and 2-month follow-ups (after very brief questionnaire surveys). Participants' contact information will be forwarded to SC service providers within 7 days, and providers are expected to contact participants within 1-2 weeks. Research staff will also monitor participants' use of SC services at each follow-up (1-, 2-, 3-, and 6-month) and, at the 1- and 2-month follow-ups, assist participants in booking or rebooking appointments if necessary. Investigators shall liaise with existing service providers and seek their assistance in promptly supporting our smokers.
12 weeks of chatbot-based instant messaging supportBehavioural
Participants in the intervention group will receive 12 weeks of instant messaging support delivered by an LLM-based chatbot (GPT-4o or newer) on WhatsApp, supporting text and audio input. Using prompt engineering, agent techniques, and Retrieval-Augmented Generation, the chatbot delivers theory-based 5As/5Rs-structured interventions alongside freeform, on-demand support, with engagement features including personalisation, proactive check-ins, and interactive Quick Commands.
12 weeks of human-led instant messaging supportBehavioural
Participants in the control group will receive 12 weeks of instant messaging support delivered by a trained human counsellor via WhatsApp. Using the same theoretical frameworks as the chatbot intervention, the counsellor will provide real-time behavioural and psychosocial support grounded in the 5As/5Rs models, Motivational Interviewing (MI), and evidence-based Behaviour Change Techniques (BCTs). The support will be personalised according to each participant's sociodemographic characteristics, smoking patterns, quit intentions, and plans.
Reminder messagesBehavioural
WhatsApp messages on follow-up survey reminders.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: AWARD advice; Behavioral: Brief leaflet on health warning and smoking cessation; Behavioral: Referral card; Behavioral: Self-help smoking cessation booklet; Behavioral: Personalized active referral; Behavioral: 12 weeks of chatbot-based instant messaging support; Behavioral: Reminder messages |
| Control group | Active comparator | Not described Receives: Behavioral: AWARD advice; Behavioral: Brief leaflet on health warning and smoking cessation; Behavioral: Referral card; Behavioral: Self-help smoking cessation booklet; Behavioral: Personalized active referral; Behavioral: 12 weeks of human-led instant messaging support; Behavioral: Reminder messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated abstinence
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml
Measured: 6-month follow-up
Secondary outcomes (10)
Biochemically validated abstinence
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml
Measured: 3-month follow-up
Self-reported 7-day point prevalence abstinence
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
Measured: 3- and 6-month follow-ups
Self-reported reduction
Defined by at least 50% reduction in baseline daily number of cigarettes
Measured: 1-, 2-, 3- and 6-month follow-ups
Self-reported use of smoking cessation service
Use of smoking cessation service at 1-, 2-, 3- and 6-month follow-ups.
Measured: 1-, 2-, 3- and 6-month follow-ups
Prolonged abstinence
Abstinence from smoking for 3 consecutive months at 3-month follow-up, or for 6 consecutive months at 6-month follow-up
Measured: 3-month and 6-month follow-ups
Quit attempt
Abstinence for at least 24 hours
Measured: 1-, 2-, 3-, and 6-month follow-ups
Post-cessation weight change
Self-reported change in body weight (in kilograms) from baseline to follow-up
Measured: 6-month follow-up
Self-reported mental health conditions
Patient Health Questionnaire-4 (PHQ-4): The PHQ-4 is a 4-item ultra-brief screening tool for anxiety and depression that combines the GAD-2 and PHQ-2 subscales. Each item is scored 0-3, with a total score of 0-12; subscale scores of 3 or higher indicate positive screening and warrant further clinical assessment.
Measured: Baseline and 6-month follow-up
Self-reported smoking-related health conditions
Answer "Yes" to experiencing any smoking-related health condition during smoking cessation or reduction
Measured: Baseline and 6-month follow-up
Chatbot user experience
Chatbot Usability Scale, or the 11-item Bot Usability Scale (BUS), is a validated questionnaire that evaluates chatbot usability across five dimensions (accessibility, function quality, conversation/information quality, privacy/security, and response time) using a 5-point Likert scale. The total score (11-55) is the sum of all items; a higher total score indicates better overall usability and greater user satisfaction. Higher scores on individual dimensions similarly reflect superior performance in those areas.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start27 Jun 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 998 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, Prof. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649044
- Sponsor's protocol ID
- QTW2026
- Acronym
- QTW2026
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. 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 2026: Real-time Smoking Cessation Instant Messaging Support Using a Engagement-Focused Large Language Model (LLM)-Based Chatbot
- ClinicalTrials.gov ID
- NCT07649044
- Acronym / sponsor ID
- QTW2026 / QTW2026
- Conditions
- Smoking Cessation
- Keywords
- Large-language model, Chatbot, Smoking cessation, Digital health, Engagement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 998 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Study start
- 27 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jun 2026 (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 trial is to learn if chatbot-based instant messaging works to help smoking cessation in general adult smokers. It will also learn about the experience, attitude, and perception of using an LLM-based chatbot. The main questions it aims to answer are:
- Will an engagement-focused LLM-based chatbot smoking cessation intervention have a non-inferior validated abstinence rate than the control group?
- Will an LLM-based chatbot smoking cessation intervention have a non-inferior self-reported abstinence rate, smoking reduction rate, and smoking cessation services use rate than the control group?
Researchers will compare an LLM-based chatbot smoking-cessation intervention to a human-led instant messaging support group (brief advice based on AWARD and personalised active referral) to determine whether chatbot-based instant messaging support promotes smoking cessation.
Participants in the intervention group will receive:
- AWARD advice
- Personalised active referral
- 12 weeks of chatbot-based instant messaging support (via WhatsApp)
Detailed description
Although smoking prevalence in Hong Kong has declined to 9.1% in 2023, achieving the government's target of 7.8% by 2025 remains a major public health challenge. Unassisted "cold turkey" quitting has a long-term success rate of less than 5%, whereas evidence-based behavioural and pharmacological interventions can raise success rates to approximately 20% or higher. However, existing cessation services in Hong Kong face a critical utilisation gap: only 17.5% of smokers have engaged with professional services, and merely 23% have used nicotine replacement therapy. This underutilisation suggests that traditional human-resource-intensive models may lack accessibility, scalability, and local appeal. Generative AI, particularly large language models, offers a transformative solution by delivering consistent, scalable, and personalised support. In the 2025 "Quit to Win" round, investigators integrated an LLM-based chatbot via WhatsApp and received positive qualitative feedback. Yet quantitative analysis revealed a sharp decline in engagement, with weekly participation dropping from 32% in week 1 to 14% by week 12, indicating that conversational ability alone does not guarantee sustained user commitment. To address this implementation gap, investigators have developed an engagement-focused GenAI companion that incorporates structured onboarding, context-aware personalisation, multimodal (text/audio) input, empathetic support, habit-aligned reminders, localised humour, and gamified features such as success stories and knowledge quizzes. Therefore, the current study aims to test, via a two-arm non-inferiority randomised controlled trial, the effectiveness of a comprehensive intervention combining brief cessation advice (AWARD), personalised active referral, and this engagement-enhanced GenAI chatbot support compared with human-led instant messaging counselling among current smokers who join the Quit to Win Contest across all 18 districts of Hong Kong.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: AWARD advice, Behavioral: Brief leaflet on health warning and smoking cessation, Behavioral: Referral card, Behavioral: Self-help smoking cessation booklet, Behavioral: Personalized active referral, Behavioral: 12 weeks of chatbot-based instant messaging support, Behavioral: Reminder messages |
| Control group | Active comparator | Behavioral: AWARD advice, Behavioral: Brief leaflet on health warning and smoking cessation, Behavioral: Referral card, Behavioral: Self-help smoking cessation booklet, Behavioral: Personalized active referral, Behavioral: 12 weeks of human-led instant messaging support, Behavioral: Reminder messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hong Kong residents aged 18 years or above
- Smoke at least one cigarette (including heated tobacco products) per day or use an e-cigarette daily in the preceding 3 months
- Able to communicate in Cantonese (including reading and writing Chinese)
- Saliva cotinine level ≥30 ng/mL
- Intention to quit or reduce smoking
Key exclusion criteria (2 listed)
- Smokers who have communication barriers (either physical or cognitive)
- Smokers who are currently participating in other smoking cessation programs or services
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 |
|---|---|---|
| AWARD adviceA brief (30-60 seconds) face-to-face or remote smoking cessation advice delivered using the validated AWARD model: Ask about smoking history; Warn about high health risks (accompanied by a health warning leaflet); Advise quitting as soon as possible and setting a quit date (to qualify for contest prizes); Refer to smoking cessation services using a referral card; Do it again - repeat the intervention at each follow-up, encouraging re-quitting after relapse or relapse prevention after success. | Behavioural | Control group, Intervention group |
| Brief leaflet on health warning and smoking cessationA two-sided, colour-printed A4 leaflet covering: (1) absolute risk of death from smoking; (2) full list of diseases caused by active and second-hand smoking; (3) ten pictorial warnings of health consequences on one page for maximum impact; (4) benefits of smoking cessation; and (5) simple encouraging messages to quit. | Behavioural | Control group, Intervention group |
| Referral cardA three-folded card containing brief information and highlights of existing smoking cessation services in Hong Kong, contact methods, motivational messages, and strong supporting slogans. | Behavioural | Control group, Intervention group |
| Self-help smoking cessation bookletA generic booklet provided covering: benefits of quitting, smoking-related diseases, methods to quit, how to handle withdrawal symptoms, a quitting declaration, and other practical tips. | Behavioural | Control group, Intervention group |
| Personalized active referralSmokers will be introduced to various SC services in Hong Kong (via the referral card) and motivated to use them. Well-trained SC ambassadors will assist smokers in choosing their favourite or most convenient type of service. Research staff will assist participants in booking or re-booking the SC services at the 1- and 2-month follow-ups (after very brief questionnaire surveys). Participants' contact information will be forwarded to SC service providers within 7 days, and providers are expected to contact participants within 1-2 weeks. Research staff will also monitor participants' use of SC services at each follow-up (1-, 2-, 3-, and 6-month) and, at the 1- and 2-month follow-ups, assist participants in booking or rebooking appointments if necessary. Investigators shall liaise with existing service providers and seek their assistance in promptly supporting our smokers. | Behavioural | Control group, Intervention group |
| 12 weeks of chatbot-based instant messaging supportParticipants in the intervention group will receive 12 weeks of instant messaging support delivered by an LLM-based chatbot (GPT-4o or newer) on WhatsApp, supporting text and audio input. Using prompt engineering, agent techniques, and Retrieval-Augmented Generation, the chatbot delivers theory-based 5As/5Rs-structured interventions alongside freeform, on-demand support, with engagement features including personalisation, proactive check-ins, and interactive Quick Commands. | Behavioural | Intervention group |
| 12 weeks of human-led instant messaging supportParticipants in the control group will receive 12 weeks of instant messaging support delivered by a trained human counsellor via WhatsApp. Using the same theoretical frameworks as the chatbot intervention, the counsellor will provide real-time behavioural and psychosocial support grounded in the 5As/5Rs models, Motivational Interviewing (MI), and evidence-based Behaviour Change Techniques (BCTs). The support will be personalised according to each participant's sociodemographic characteristics, smoking patterns, quit intentions, and plans. | Behavioural | Control group |
| Reminder messagesWhatsApp messages on follow-up survey reminders. | Behavioural | Control group, Intervention group |
Primary outcome
Biochemically validated abstinence
Time frame: 6-month follow-up
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml
10 secondary outcomes
Biochemically validated abstinence
Time frame: 3-month follow-up
Self-reported 7-day point prevalence abstinence
Time frame: 3- and 6-month follow-ups
Self-reported reduction
Time frame: 1-, 2-, 3- and 6-month follow-ups
Self-reported use of smoking cessation service
Time frame: 1-, 2-, 3- and 6-month follow-ups
Prolonged abstinence
Time frame: 3-month and 6-month follow-ups
Quit attempt
Time frame: 1-, 2-, 3-, and 6-month follow-ups
Post-cessation weight change
Time frame: 6-month follow-up
Self-reported mental health conditions
Time frame: Baseline and 6-month follow-up
Self-reported smoking-related health conditions
Time frame: Baseline and 6-month follow-up
Chatbot user experience
Time frame: 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- 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.
Man Ping Wang 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 AWARD advice, Brief leaflet on health warning and smoking cessation and Referral card in people with Smoking Cessation, 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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man Ping Wang, PhD (+852 3917 6636, mpwang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated abstinence (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.