Smoking CessationNCT06914492
Real-time Smoking Cessation Instant Messaging Support Using a Large Language Model (LLM)-Based Chatbot Via "Quit to Win" 2025 (QTW2025)
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
- 1,058 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Jun 2025to 5 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 or above
- Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the past 3-month
- Able to communicate in Chinese
- Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
- Intention to quit/reducing smoking
- Have instant messaging tool (WhatsApp) installed
- Able to use the instant messaging tool (e.g., 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.
Hong Kong1 site
Hong Kong Council on Smoking and Health (COSH)
Hong Kong, Hong Kong, 999077
About this study
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2025: Real-time Smoking Cessation Instant Messaging Support Using a 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 LLM-based chatbot smoking cessation intervention have a higher validated abstinence rate than the control group?
- Will LLM-based chatbot smoking cessation intervention have a higher self-reported abstinence rate, smoking reduction rate, and smoking cessation services use rate than the control group?
Read more
Researchers will compare LLM-based chatbot smoking cessation intervention to a usual care group (brief advice based on AWARD and personalized active referral) to see if chatbot-based instant messaging support works to promote smoking cessation.
Participants in the intervention group will receive:
- AWARD advice
- Personalized active referral
- 12 weeks of chatbot-based instant messaging support (via WhatsApp)
Read the detailed description
Although smoking prevalence is decreasing in Hong Kong (1982: 23.3%; 2023: 9.1%), it accounts for over 7,000 deaths per year and a large amount of medical cost, long-term care and productivity loss of US$ 688 million (0.6% Hong Kong GDP). Quitting is difficult because nicotine is highly addictive. Long-term habitual tobacco smoking could foster a series of physical and psychological dependence on nicotine, and thus induce cravings and nicotine withdrawal symptoms when remaining abstinent. Tradition "one-intervention-for-all" approach cannot work optimally for overall smoking population because of the individual differences in the background characteristic and variations in response to the intervention. Intervention approaches that account for personalization and variation should be explored.
Preliminary studies suggest that AI-based chatbots can deliver structured counseling to support tobacco cessation through personalised, empathetic, and authentic conversations, thus enhancing the effectiveness of smoking cessation interventions. When integrated into social media, AI chatbots can provide timely, targeted responses and connect users with a resources on widely used platforms. A 2023 meta-analysis involving 58,796 participants further highlighted the promise of chatbots for tobacco cessation (RR=1.29, 95%CI 1.13-1.46).
In late 2022, the release of ChatGPT revolutionized AI and large language models by offering unprecedented reasoning and conversational capabilities, which enables the development of more sophisticated, human-like chatbots. Although ChatGPT (and the GenAI in general) was trained as a general-purpose virtual assistant, its tasks-specific performance can be significantly enhanced through prompt engineering. Leveraging this approach, we developed an LLM-based chatbot to autonomously deliver smoking cessation support via WhatsApp according to established protocols. Our previous rule-based chatbot effectively prevented smoking relapse, and a pilot trial with an LLM-based chatbot for youth smokers (n=154) showed feasibility, achieving an 80.2% retention rate. These findings support the implementation of GenAI chatbots as promising tools for brief smoking cessation interventions in adult smokers.
Therefore, our study aims to test the effectiveness of a comprehensive intervention using brief cessation advice, personalized active referral, and chatbot-based instant messaging support compared with the control group on current smokers who join the Quit to Win Contest.
- 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, Behavioral counselling, Digital health
- 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
AWARD advice include Ask about smoking history, Warn about the high risk, Advise to quit, Refer smokers to smoking cessation services (with a referral card), and Do it again.
Brief leaflet on health warning and smoking cessationBehavioural
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and second-hand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking.
Referral cardBehavioural
The contents consist of brief information and a highlight of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.
Self-help smoking cessation bookletBehavioural
The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.
Personalized active referralBehavioural
Smokers will be introduced to various SC services in Hong Kong (using the referral card) and be motivated to use these services. Well-trained SC ambassadors will assist smoker to choose favourite/most convenient or preferred type of services. 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 services providers within seven days, and providers are expected to contact the participants within 1-2 weeks. Research staff will also monitor SC services use of the participants at each follow-up (1-, 2-, 3- and 6- month) and assist participants to book or re-book the appointments if necessary at 1- and 2- month follow-up. We shall liaise with the existing service providers and seek their assistance in helping our smokers in helping our smokers in a timely manner.
12 weeks of chatbot-based instant messaging supportBehavioural
Participants in the intervention group will receive 12 weeks of instant messaging support delivered by the LLM-based chatbot accessible via WhatsApp platform. The chatbot, powered by GPT-4o model (or more advanced model available) using prompt-engineering and agent-based techniques, will deliver brief theory-based, structured SC intervention alongside freeform, on-demand support. The structured intervention session deploys the 5As model (Ask, Advise, Assess, Assist, and Arrange follow-up) and 5Rs model (Relevance, Risks, Rewards, Roadblocks, Repetition), as used in our previous telephone-counselling trials and recommended by WHO for brief SC intervention.
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: 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 (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start21 Jun 2025
- Primary completion31 May 2026
- Study completion5 Jun 2026
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
- 1,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914492
- Sponsor's protocol ID
- QTW2025
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 10 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 10 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 2025: Real-time Smoking Cessation Instant Messaging Support Using a Large Language Model (LLM)-Based Chatbot
- ClinicalTrials.gov ID
- NCT06914492
- Acronym / sponsor ID
- QTW2025
- Conditions
- Smoking Cessation
- Keywords
- Large-language model, Chatbot, Smoking cessation, Behavioral counselling, Digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,058 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 6 Apr 2025 (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 LLM-based chatbot smoking cessation intervention have a higher validated abstinence rate than the control group?
- Will LLM-based chatbot smoking cessation intervention have a higher self-reported abstinence rate, smoking reduction rate, and smoking cessation services use rate than the control group?
Researchers will compare LLM-based chatbot smoking cessation intervention to a usual care group (brief advice based on AWARD and personalized active referral) to see if chatbot-based instant messaging support works to promote smoking cessation.
Participants in the intervention group will receive:
- AWARD advice
- Personalized active referral
- 12 weeks of chatbot-based instant messaging support (via WhatsApp)
Detailed description
Although smoking prevalence is decreasing in Hong Kong (1982: 23.3%; 2023: 9.1%), it accounts for over 7,000 deaths per year and a large amount of medical cost, long-term care and productivity loss of US$ 688 million (0.6% Hong Kong GDP). Quitting is difficult because nicotine is highly addictive. Long-term habitual tobacco smoking could foster a series of physical and psychological dependence on nicotine, and thus induce cravings and nicotine withdrawal symptoms when remaining abstinent. Tradition "one-intervention-for-all" approach cannot work optimally for overall smoking population because of the individual differences in the background characteristic and variations in response to the intervention. Intervention approaches that account for personalization and variation should be explored.
Preliminary studies suggest that AI-based chatbots can deliver structured counseling to support tobacco cessation through personalised, empathetic, and authentic conversations, thus enhancing the effectiveness of smoking cessation interventions. When integrated into social media, AI chatbots can provide timely, targeted responses and connect users with a resources on widely used platforms. A 2023 meta-analysis involving 58,796 participants further highlighted the promise of chatbots for tobacco cessation (RR=1.29, 95%CI 1.13-1.46).
In late 2022, the release of ChatGPT revolutionized AI and large language models by offering unprecedented reasoning and conversational capabilities, which enables the development of more sophisticated, human-like chatbots. Although ChatGPT (and the GenAI in general) was trained as a general-purpose virtual assistant, its tasks-specific performance can be significantly enhanced through prompt engineering. Leveraging this approach, we developed an LLM-based chatbot to autonomously deliver smoking cessation support via WhatsApp according to established protocols. Our previous rule-based chatbot effectively prevented smoking relapse, and a pilot trial with an LLM-based chatbot for youth smokers (n=154) showed feasibility, achieving an 80.2% retention rate. These findings support the implementation of GenAI chatbots as promising tools for brief smoking cessation interventions in adult smokers.
Therefore, our study aims to test the effectiveness of a comprehensive intervention using brief cessation advice, personalized active referral, and chatbot-based instant messaging support compared with the control group on current smokers who join the Quit to Win Contest.
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: 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 or above
- Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the past 3-month
- Able to communicate in Chinese
- Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
- Intention to quit/reducing 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 adviceAWARD advice include Ask about smoking history, Warn about the high risk, Advise to quit, Refer smokers to smoking cessation services (with a referral card), and Do it again. | Behavioural | Control group, Intervention group |
| Brief leaflet on health warning and smoking cessationThe contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and second-hand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking. | Behavioural | Control group, Intervention group |
| Referral cardThe contents consist of brief information and a highlight of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans. | Behavioural | Control group, Intervention group |
| Self-help smoking cessation bookletThe contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc. | Behavioural | Control group, Intervention group |
| Personalized active referralSmokers will be introduced to various SC services in Hong Kong (using the referral card) and be motivated to use these services. Well-trained SC ambassadors will assist smoker to choose favourite/most convenient or preferred type of services. 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 services providers within seven days, and providers are expected to contact the participants within 1-2 weeks. Research staff will also monitor SC services use of the participants at each follow-up (1-, 2-, 3- and 6- month) and assist participants to book or re-book the appointments if necessary at 1- and 2- month follow-up. We shall liaise with the existing service providers and seek their assistance in helping our smokers in helping our smokers in a timely manner. | 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 the LLM-based chatbot accessible via WhatsApp platform. The chatbot, powered by GPT-4o model (or more advanced model available) using prompt-engineering and agent-based techniques, will deliver brief theory-based, structured SC intervention alongside freeform, on-demand support. The structured intervention session deploys the 5As model (Ask, Advise, Assess, Assist, and Arrange follow-up) and 5Rs model (Relevance, Risks, Rewards, Roadblocks, Repetition), as used in our previous telephone-counselling trials and recommended by WHO for brief SC intervention. | Behavioural | Intervention 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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
Smoking Cessation, Smoking
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.
Man Ping Wang, PhD 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: finished, as of the sponsor's last update on 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 10 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.