- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Verhalten: Erinnerungsnachrichten
- Verhalten: AWARD advice
- Verhalten: Brief leaflet on health warning and smoking cessation
- Verhalten: Referral card
- Verhalten: Self-help smoking cessation booklet
- Verhalten: Personalized active referral
- Verhalten: 12 weeks of chatbot-based instant messaging support
- Verhalten: 12 weeks of human-led instant messaging support
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Man Ping Wang, PhD
- Telefonnummer: +852 3917 6636
- E-Mail: mpwang@hku.hk
Studieren Sie die Kontaktsicherung
- Name: Yilan Wu
- Telefonnummer: +852 56497578
- E-Mail: visspalan@connect.hku.hk
Studienorte
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Hong Kong
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Hong Kong, Hong Kong, Hongkong, 999077
- Hong Kong Council on Smoking and Health (COSH)
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Kontakt:
- Man Ping Wang, PhD
- Telefonnummer: +852 3917 6636
- E-Mail: mpwang@hku.hk
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Unterermittler:
- Shengzhi Zhao, PhD
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Unterermittler:
- Xiaoyun Xie, MPH
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Unterermittler:
- Mengyao Li, Mphil
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Kontakt:
- Yilan Wu
- Telefonnummer: +852 56497578
- E-Mail: visspalan@connect.hku.hk
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Hauptermittler:
- Man Ping Wang
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Unterermittler:
- Ziqiu Guo, PhD
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Unterermittler:
- Yilan Wu, MGH
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Interventionsgruppe
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WhatsApp-Nachrichten in Follow-up-Umfrageerinnerungen.
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.
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Aktiver Komparator: Kontrollgruppe
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WhatsApp-Nachrichten in Follow-up-Umfrageerinnerungen.
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Biochemisch validierte Abstinenz
Zeitfenster: 6-Monats-Follow-up
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Definiert als ausgeatmeter CO-Gehalt <4 ppm und Speichel-Cotinin-Gehalt ≤30 ng/ml
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6-Monats-Follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Biochemisch validierte Abstinenz
Zeitfenster: 3-Monats-Follow-up
|
Definiert als ausgeatmeter CO-Gehalt <4 ppm und Speichel-Cotinin-Gehalt ≤30 ng/ml
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3-Monats-Follow-up
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Selbst gemeldete 7-Tage-Punktprävalenzabstinenz
Zeitfenster: 3- und 6-Monats-Follow-ups
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Raucher, die in den 7 Tagen vor der Follow-up nicht einmal einen Puff rauchten
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3- und 6-Monats-Follow-ups
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Selbst berichtete Reduktion
Zeitfenster: 1-, 2-, 3- und 6-Monats-Follow-ups
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Definiert durch mindestens 50% Reduzierung der täglichen Anzahl der Zigaretten
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1-, 2-, 3- und 6-Monats-Follow-ups
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Selbst gemeldete Verwendung des Raucherentwöhnungsdienstes
Zeitfenster: 1-, 2-, 3- und 6-Monats-Follow-ups
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Verwendung des Raucherentwöhnungsdienstes bei 1-, 2-, 3- und 6-Monats-Follow-ups.
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1-, 2-, 3- und 6-Monats-Follow-ups
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Prolonged abstinence
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 mental health conditions
Zeitfenster: Baseline and 6-month follow-up
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Patient Health Questionnaire-4 (PHQ-4)
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Baseline and 6-month follow-up
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Self-reported smoking-related health conditions
Zeitfenster: 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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Chatbot user experience
Zeitfenster: 3-month follow-up
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Chatbot Usability Scale
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3-month follow-up
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Man Ping Wang, The University of Hong Kong
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QTW2026
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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