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Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Engagement-Focused GenAI-based Chatbot for Real-Time Smoking Cessation Support (QTW2026)

26. Juni 2026 aktualisiert von: Prof. Wang Man-Ping, The University of Hong Kong

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:

  1. Will an engagement-focused LLM-based chatbot smoking cessation intervention have a non-inferior validated abstinence rate than the control group?
  2. 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:

  1. AWARD advice
  2. Personalised active referral
  3. 12 weeks of chatbot-based instant messaging support (via WhatsApp)

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

998

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Man Ping Wang, PhD
  • Telefonnummer: +852 3917 6636
  • E-Mail: mpwang@hku.hk

Studieren Sie die Kontaktsicherung

Studienorte

  • Hongkong
    • Hong Kong
      • Hong Kong, Hong Kong, Hongkong, 999077
        • Hong Kong Council on Smoking and Health (COSH)
        • Kontakt:
          • Man Ping Wang, PhD
          • Telefonnummer: +852 3917 6636
          • E-Mail: mpwang@hku.hk
        • Unterermittler:
          • Shengzhi Zhao, PhD
        • Unterermittler:
          • Xiaoyun Xie, MPH
        • Unterermittler:
          • Mengyao Li, Mphil
        • Kontakt:
        • Hauptermittler:
          • Man Ping Wang
        • Unterermittler:
          • Ziqiu Guo, PhD
        • Unterermittler:
          • Yilan Wu, MGH
        • Unterermittler:
          • Patrick IP, MD, PhD
        • Unterermittler:
          • Ning Huang, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Hong Kong residents aged 18 years or above
  2. Smoke at least one cigarette (including heated tobacco products) per day or use an e-cigarette daily in the preceding 3 months
  3. Able to communicate in Cantonese (including reading and writing Chinese)
  4. Saliva cotinine level ≥30 ng/mL
  5. Intention to quit or reduce smoking
  6. Have WhatsApp installed
  7. Able to use WhatsApp for communication

Exclusion Criteria:

  1. Smokers who have communication barriers (either physical or cognitive)
  2. Smokers who are currently participating in other smoking cessation programs or services

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Interventionsgruppe
Verhalten: Erinnerungsnachrichten
WhatsApp-Nachrichten in Follow-up-Umfrageerinnerungen.
Verhalten: AWARD advice
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.
Verhalten: Brief leaflet on health warning and smoking cessation
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.
Verhalten: Referral card
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.
Verhalten: Self-help smoking cessation booklet
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.
Verhalten: 12 weeks of chatbot-based instant messaging support
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.
Verhalten: Personalized active referral
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.
Aktiver Komparator: Kontrollgruppe
Verhalten: Erinnerungsnachrichten
WhatsApp-Nachrichten in Follow-up-Umfrageerinnerungen.
Verhalten: AWARD advice
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.
Verhalten: Brief leaflet on health warning and smoking cessation
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.
Verhalten: Referral card
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.
Verhalten: Self-help smoking cessation booklet
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.
Verhalten: 12 weeks of human-led instant messaging support
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.
Verhalten: Personalized active referral
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biochemisch validierte Abstinenz
Zeitfenster: 6-Monats-Follow-up
Definiert als ausgeatmeter CO-Gehalt <4 ppm und Speichel-Cotinin-Gehalt ≤30 ng/ml
6-Monats-Follow-up

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Biochemisch validierte Abstinenz
Zeitfenster: 3-Monats-Follow-up
Definiert als ausgeatmeter CO-Gehalt <4 ppm und Speichel-Cotinin-Gehalt ≤30 ng/ml
3-Monats-Follow-up
Selbst gemeldete 7-Tage-Punktprävalenzabstinenz
Zeitfenster: 3- und 6-Monats-Follow-ups
Raucher, die in den 7 Tagen vor der Follow-up nicht einmal einen Puff rauchten
3- und 6-Monats-Follow-ups
Selbst berichtete Reduktion
Zeitfenster: 1-, 2-, 3- und 6-Monats-Follow-ups
Definiert durch mindestens 50% Reduzierung der täglichen Anzahl der Zigaretten
1-, 2-, 3- und 6-Monats-Follow-ups
Selbst gemeldete Verwendung des Raucherentwöhnungsdienstes
Zeitfenster: 1-, 2-, 3- und 6-Monats-Follow-ups
Verwendung des Raucherentwöhnungsdienstes bei 1-, 2-, 3- und 6-Monats-Follow-ups.
1-, 2-, 3- und 6-Monats-Follow-ups
Prolonged abstinence
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6-month follow-up
Self-reported change in body weight (in kilograms) from baseline to follow-up
6-month follow-up
Self-reported smoking-related health conditions
Zeitfenster: 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
Self-reported mental health conditions
Zeitfenster: Baseline and 6-month follow-up
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.
Baseline and 6-month follow-up
Chatbot user experience
Zeitfenster: 3-month follow-up
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.
3-month follow-up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The University of Hong Kong

Mitarbeiter

Hong Kong Council on Smoking and Health

Ermittler

  • Hauptermittler: Man Ping Wang, The University of Hong Kong

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

27. Juni 2026

Primärer Abschluss (Geschätzt)

30. Oktober 2027

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • QTW2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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