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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 de junio de 2026 actualizado por: 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)

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

998

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Man Ping Wang, PhD
  • Número de teléfono: +852 3917 6636
  • Correo electrónico: mpwang@hku.hk

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 999077
        • Hong Kong Council on Smoking and Health (COSH)
        • Contacto:
          • Man Ping Wang, PhD
          • Número de teléfono: +852 3917 6636
          • Correo electrónico: mpwang@hku.hk
        • Sub-Investigador:
          • Shengzhi Zhao, PhD
        • Sub-Investigador:
          • Xiaoyun Xie, MPH
        • Sub-Investigador:
          • Mengyao Li, Mphil
        • Contacto:
        • Investigador principal:
          • Man Ping Wang
        • Sub-Investigador:
          • Ziqiu Guo, PhD
        • Sub-Investigador:
          • Yilan Wu, MGH
        • Sub-Investigador:
          • Patrick IP, MD, PhD
        • Sub-Investigador:
          • Ning Huang, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Grupo de intervención
Mensajes de WhatsApp en recordatorios de encuestas de seguimiento.
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.
Comparador activo: Grupo de control
Mensajes de WhatsApp en recordatorios de encuestas de seguimiento.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Abstinencia validada bioquímicamente
Periodo de tiempo: Seguimiento de 6 meses
Definido como nivel de CO exhalado <4ppm y nivel de cotinina en saliva ≤30 ng/ml
Seguimiento de 6 meses

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Abstinencia validada bioquímicamente
Periodo de tiempo: Seguimiento de 3 meses
Definido como nivel de CO exhalado <4ppm y nivel de cotinina en saliva ≤30 ng/ml
Seguimiento de 3 meses
Abstinencia de prevalencia de puntos de 7 días autoinformados
Periodo de tiempo: Seguimientos de 3 y 6 meses
Fumadores que no fumaron ni siquiera una bocanada en los 7 días anteriores al seguimiento
Seguimientos de 3 y 6 meses
Reducción autoinformada
Periodo de tiempo: Seguimientos de 1, 2, 3 y 6 meses
Definido por al menos una reducción del 50% en el número diario de la línea de base de cigarrillos
Seguimientos de 1, 2, 3 y 6 meses
Uso autoinformado del servicio para dejar de fumar
Periodo de tiempo: Seguimientos de 1, 2, 3 y 6 meses
Uso del servicio para dejar de fumar en seguimientos de 1, 2, 3 y 6 meses.
Seguimientos de 1, 2, 3 y 6 meses
Prolonged abstinence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Man Ping Wang, The University of Hong Kong

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

27 de junio de 2026

Finalización primaria (Estimado)

30 de octubre de 2027

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • QTW2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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