- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07649044
Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Engagement-Focused GenAI-based Chatbot for Real-Time Smoking Cessation Support (QTW2026)
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?
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)
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Reminder messages
- 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: 12 weeks of human-led instant messaging support
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Man Ping Wang, PhD
- Phone Number: +852 3917 6636
- Email: mpwang@hku.hk
Study Contact Backup
- Name: Yilan Wu
- Phone Number: +852 56497578
- Email: visspalan@connect.hku.hk
Study Locations
-
-
Hong Kong
-
Hong Kong, Hong Kong, Hong Kong, 999077
- Hong Kong Council on Smoking and Health (COSH)
-
Contact:
- Man Ping Wang, PhD
- Phone Number: +852 3917 6636
- Email: mpwang@hku.hk
-
Sub-Investigator:
- Shengzhi Zhao, PhD
-
Sub-Investigator:
- Xiaoyun Xie, MPH
-
Sub-Investigator:
- Mengyao Li, Mphil
-
Contact:
- Yilan Wu
- Phone Number: +852 56497578
- Email: visspalan@connect.hku.hk
-
Principal Investigator:
- Man Ping Wang
-
Sub-Investigator:
- Ziqiu Guo, PhD
-
Sub-Investigator:
- Yilan Wu, MGH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Currently participating in other smoking cessation programmes or using any smoking cessation drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
WhatsApp messages on follow-up survey reminders.
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.
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.
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.
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.
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 assist participants in booking or rebooking appointments if necessary at the 1- and 2-month follow-ups.
We shall liaise with the existing service providers and seek their assistance in supporting our smokers in a timely manner.
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.
|
|
Active Comparator: Control group
|
WhatsApp messages on follow-up survey reminders.
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.
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.
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.
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.
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 assist participants in booking or rebooking appointments if necessary at the 1- and 2-month follow-ups.
We shall liaise with the existing service providers and seek their assistance in supporting our smokers in a timely manner.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemically validated abstinence
Time Frame: 6-month follow-up
|
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml
|
6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemically validated abstinence
Time Frame: 3-month follow-up
|
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml
|
3-month follow-up
|
|
Self-reported 7-day point prevalence abstinence
Time Frame: 3- and 6-month follow-ups
|
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
|
3- and 6-month follow-ups
|
|
Self-reported reduction
Time Frame: 1-, 2-, 3- and 6-month follow-ups
|
Defined by at least 50% reduction in baseline daily number of cigarettes
|
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
|
Use of smoking cessation service at 1-, 2-, 3- and 6-month follow-ups.
|
1-, 2-, 3- and 6-month follow-ups
|
|
Prolonged abstinence
Time Frame: 3-month and 6-month follow-ups
|
Abstinence from smoking for 3 consecutive months at 3-month follow-up, or for 6 consecutive months at 6-month follow-up
|
3-month and 6-month follow-ups
|
|
Quit attempt
Time Frame: 1-, 2-, 3-, and 6-month follow-ups
|
Abstinence for at least 24 hours
|
1-, 2-, 3-, and 6-month follow-ups
|
|
Post-cessation weight change
Time Frame: 6-month follow-up
|
Self-reported change in body weight (in kilograms) from baseline to follow-up
|
6-month follow-up
|
|
Self-reported mental health conditions
Time Frame: Baseline and 6-month follow-up
|
Patient Health Questionnaire-4 (PHQ-4)
|
Baseline and 6-month follow-up
|
|
Self-reported smoking-related health conditions
Time Frame: Baseline and 6-month follow-up
|
Answer "Yes" to experiencing any smoking-related health condition during smoking cessation or reduction
|
Baseline and 6-month follow-up
|
|
Chatbot user experience
Time Frame: 3-month follow-up
|
Chatbot Usability Scale
|
3-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Man Ping Wang, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QTW2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
Clinical Trials on Reminder messages
-
African Strategies for HealthUnited States Agency for International Development (USAID)UnknownEffects of the SMS Mother Reminder System on Use of Health Care.Uganda
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Recruiting
-
Necmettin Erbakan UniversityActive, not recruiting
-
Boston Medical CenterWithdrawn
-
University of ArizonaAmerican Lung Association; Pima County Health DepartmentCompletedLatent TuberculosisUnited States
-
Halmstad UniversityRegion HallandUnknown
-
University of Wisconsin, MadisonNational Institute of Dental and Craniofacial Research (NIDCR)Active, not recruitingDental CareUnited States
-
University of Colorado, DenverNational Cancer Institute (NCI)RecruitingImplementation Strategy Bundles for Structured Follow-upUnited States
-
University of ChileUniversity Diego Portales; Millennium Nucleus to Improve the Mental Health... and other collaboratorsCompletedSuicidal Ideation | Suicidal BehaviorChile
-
National University Hospital, SingaporeEnrolling by invitationThis Study Evaluates Interventions to Increase Surveillance Mammography Uptake for Early Breast Cancer Detection Among Singaporean WomenSingapore