- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Atferdsmessig: Påminnelsesmeldinger
- Atferdsmessig: AWARD advice
- Atferdsmessig: Brief leaflet on health warning and smoking cessation
- Atferdsmessig: Referral card
- Atferdsmessig: Self-help smoking cessation booklet
- Atferdsmessig: 12 weeks of chatbot-based instant messaging support
- Atferdsmessig: 12 weeks of human-led instant messaging support
- Atferdsmessig: Personalized active referral
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Man Ping Wang, PhD
- Telefonnummer: +852 3917 6636
- E-post: mpwang@hku.hk
Studer Kontakt Backup
- Navn: Yilan Wu
- Telefonnummer: +852 56497578
- E-post: visspalan@connect.hku.hk
Studiesteder
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 999077
- Hong Kong Council on Smoking and Health (COSH)
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Ta kontakt med:
- Man Ping Wang, PhD
- Telefonnummer: +852 3917 6636
- E-post: mpwang@hku.hk
-
Underetterforsker:
- Shengzhi Zhao, PhD
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Underetterforsker:
- Xiaoyun Xie, MPH
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Underetterforsker:
- Mengyao Li, Mphil
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Ta kontakt med:
- Yilan Wu
- Telefonnummer: +852 56497578
- E-post: visspalan@connect.hku.hk
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Hovedetterforsker:
- Man Ping Wang
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Underetterforsker:
- Ziqiu Guo, PhD
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Underetterforsker:
- Yilan Wu, MGH
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Underetterforsker:
- Patrick IP, MD, PhD
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Underetterforsker:
- Ning Huang, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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:
- Smokers who have communication barriers (either physical or cognitive)
- Smokers who are currently participating in other smoking cessation programs or services
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Intervensjonsgruppe
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WhatsApp-meldinger om påminnelser om oppfølgingsundersøkelse.
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.
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.
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.
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Aktiv komparator: Kontrollgruppe
|
WhatsApp-meldinger om påminnelser om oppfølgingsundersøkelse.
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.
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.
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Biokjemisk validert abstinens
Tidsramme: 6 måneders oppfølging
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Definert som utåndet CO-nivå <4ppm og spyttkotininnivå ≤30 ng/ml
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6 måneders oppfølging
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Biokjemisk validert abstinens
Tidsramme: 3 måneders oppfølging
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Definert som utåndet CO-nivå <4ppm og spyttkotininnivå ≤30 ng/ml
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3 måneders oppfølging
|
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Selvrapportert 7-dagers poengutbredelse avholdenhet
Tidsramme: 3- og 6-måneders oppfølging
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Røykere som ikke røyk
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3- og 6-måneders oppfølging
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Selvrapportert reduksjon
Tidsramme: 1-, 2-, 3- og 6-måneders oppfølging
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Definert av minst 50% reduksjon i baseline daglig antall sigaretter
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1-, 2-, 3- og 6-måneders oppfølging
|
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Selvrapportert bruk av røykesluttstjeneste
Tidsramme: 1-, 2-, 3- og 6-måneders oppfølging
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Bruk av røykesluttstjeneste ved 1-, 2-, 3- og 6-måneders oppfølging.
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1-, 2-, 3- og 6-måneders oppfølging
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Prolonged abstinence
Tidsramme: 3-month and 6-month follow-ups
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Abstinence from smoking for 3 consecutive months at 3-month follow-up, or for 6 consecutive months at 6-month follow-up
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3-month and 6-month follow-ups
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Quit attempt
Tidsramme: 1-, 2-, 3-, and 6-month follow-ups
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Abstinence for at least 24 hours
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1-, 2-, 3-, and 6-month follow-ups
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Post-cessation weight change
Tidsramme: 6-month follow-up
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Self-reported change in body weight (in kilograms) from baseline to follow-up
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6-month follow-up
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Self-reported smoking-related health conditions
Tidsramme: Baseline and 6-month follow-up
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Answer "Yes" to experiencing any smoking-related health condition during smoking cessation or reduction
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Baseline and 6-month follow-up
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Self-reported mental health conditions
Tidsramme: Baseline and 6-month follow-up
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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.
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Baseline and 6-month follow-up
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Chatbot user experience
Tidsramme: 3-month follow-up
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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.
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3-month follow-up
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Man Ping Wang, The University of Hong Kong
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QTW2026
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