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- Essai clinique NCT07649018
Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke
Build to Quit 「築建無煙」: Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke: A Pragmatic, Pilot, Cluster Randomized Controlled Trial
The goal of this pilot trial is to learn if 1-week NRT sampling, 3-week chewing gum, and 12-week chatbot-delivered instant messaging support works to help smoking cessation in construction workers who smoke. It will also learn about the feasibility, acceptability, and preliminary effectiveness of delivering the comprehensive intervention in construction settings. The main questions it aims to answer are:
- Will the integrated intervention, comprising NRT sampling, chewing gum, and chatbot-delivered instant messaging support, show feasibility, acceptability, and appropriateness for delivery in construction worksite settings?
- Will participants who receive the comprehensive intervention have a higher validated abstinence rate than those who receive NRT sampling alone?
Researchers will compare the integrated intervention, comprising NRT sampling, chewing gum, and chatbot-delivered instant messaging support, to the standard care group (NRT sampling alone) to see if the integrated intervention works to promote smoking cessation.
Participants in the intervention group will receive:
- AWARD advice and brief video
- 1-week NRT sampling
- 3-week chewing gum
- 12-week chatbot-based instant messaging support (via WhatsApp)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Comportemental: Livret d'auto-assistance pour arrêter de fumer
- Comportemental: Conseil d'attribution
- Comportemental: Carte de référence
- Comportemental: Brief leaflet on health warning and smoking cessation
- Médicament: 1-week nicotine gum
- Comportemental: 3-week chewing gum
- Comportemental: 12-week chatbot-based instant messaging support
- Comportemental: Brief video
Description détaillée
Hong Kong has achieved a sustained reduction in daily cigarette smoking, from 23.3% in the early 1980s to 8.5% in 2025. However, the current prevalence remains above the Government's Towards 2025 target of 7.8%, indicating the need for continued and targeted cessation efforts. The construction industry represents a particularly important setting for intervention, as recent legislative amendments to designate construction sites as no-smoking areas have further strengthened the policy basis for promoting smoke-free worksites.
Construction workers (CWs) are a high-priority population for smoking cessation because they have consistently higher smoking prevalence than many other occupational groups and the general population. In Hong Kong, a workplace health study found that 45% of construction workers were daily smokers, nearly twice the prevalence among office clerks/professionals. For CWs, smoking may compound existing occupational health risks by increasing susceptibility to respiratory and cardiovascular diseases in a physically demanding and dust-exposed work environment.
This study proposes a comprehensive worksite-targeted smoking cessation intervention model for CWs who smoke in Hong Kong, integrating NRT sampling, chewing gum support, and chatbot-delivered instant messaging. NRT is an evidence-based pharmacotherapy for reducing nicotine withdrawal symptoms and supporting smoking abstinence, and has been widely used in community-based cessation interventions. For CWs, short-term NRT sampling may provide immediate access to evidence-based pharmacological support, reduce early withdrawal symptoms, and lower the initial barrier to treatment uptake in a worksite setting. Chewing gum may complement NRT sampling by serving as a low-cost behavioral substitute for smoking, particularly by replacing the hand-to-mouth and oral routines associated with cigarette use. Chatbot-delivered instant messaging support can further extend the intervention beyond the worksite by providing 24/7 support, reminders for NRT and chewing gum use, and real-time assistance during cravings or high-risk smoking situations.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Man Ping Wang, PhD
- Numéro de téléphone: +852 3917 6636
- E-mail: mpwang@hku.hk
Sauvegarde des contacts de l'étude
- Nom: Mengyao Li, Mphil
- Numéro de téléphone: +852 6851 8462
- E-mail: lmy0814@connect.hku.hk
Lieux d'étude
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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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Contact:
- Fung Wong
- Numéro de téléphone: +852 2180 5186
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Sous-enquêteur:
- Tai Hing Lam, MD
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Sous-enquêteur:
- Tzu Tsun Luk, PhD
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Sous-enquêteur:
- Xiaoyun Xie, MPH
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Sous-enquêteur:
- Mengyao Li, Mphil
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Sous-enquêteur:
- Ziqiu Guo, PhD
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Sous-enquêteur:
- Yilan Wu, Mphil
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Smoke at least one cigarette per day in the preceding 3-month
- Able to communicate in Cantonese (including reading and writing Chinese)
- Saliva cotinine 30 ng/ml or above
- Intent to quit / reduce smoking
- Have instant messaging tool (WhatsApp) installed
- Able to use instant messaging tool (e.g., WhatsApp) for communication.
Exclusion Criteria:
- Smokers who are participating in other smoking cessation programmes
- Smokers who are using any smoking cessation medication
- Smokers who are presenting with the following oral diseases, including recent oral surgery or tooth extraction, unstable dentures, significant tooth mobility or advanced periodontal disease, temporomandibular pain or dysfunction, or painful oral mucosal lesions
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Groupe d'intervention
|
Le contenu comprend des informations sur les avantages de l'arrêt, du tabagisme et des maladies, les méthodes pour arrêter, la gestion des symptômes de sevrage, la déclaration d'arrêt, etc.
Les conseils de récompense incluent Ask sur les antécédents du tabagisme, mettent en garde contre le risque élevé, conseiller de cesser de fumer, de référer aux fumeurs des services de sevrage tabagique (avec une carte de référence) et de recommencer.
Le contenu comprend des informations brèves et un point culminant des services de sevrage tabagique existants, des méthodes de contact, des informations de motivation et de solides messages ou slogans de soutien.
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and secondhand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking.
Participants in both group will receive a 1-week supply of free nicotine gum (2 mg or 4 mg).
The dosage of nicotine gum will be guided by participants' daily cigarette consumption, in accordance with recommendations from the Department of Health.
Research assistants will explain the benefits of NRT for smoking cessation, provide instructions on the correct use of nicotine gum, encourage participants to continue using nicotine gum after completing the free sample where appropriate, and advise participants to reduce smoking or make a quit attempt when using NRT.
Participants in the intervention group will receive 6 packs of chewing gum at baseline (2 packs per week).
Chewing gum will be presented as a practical strategy to replace the hand-to-mouth and oral routines associated with smoking, particularly during work breaks, after meals, in other smoking-related situations at construction sites, or when participants are unwilling to use nicotine gum.
Participants in the intervention group will receive 12 weeks of instant messaging support delivered by the LLM-based chatbot accessible via WhatsApp platform.
The chatbot, powered by Claude model (or more advanced model available) using prompt-engineering and agent-based techniques, will deliver theory-based and structured intervention alongside freeform, on-demand support.
The structured intervention session deploys the 5As model (Ask, Advise, Assess, Assist, and Arrange follow-up) and 5Rs model (Relevance, Risks, Rewards, Roadblocks, Repetition), as used in our previous telephone-counselling trials and recommended by WHO for brief SC intervention.
Participants in both groups will receive a brief motivational video (15-second) via WhatsApp.
The video will feature a construction worker who successfully quit smoking in our previous trial, providing a relatable peer role model for participants.
The video will welcome participants to the programme, encourage them to make a quit attempt, and promote early use of nicotine gum as a practical strategy for managing cravings and supporting smoking cessation.
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Comparateur actif: Groupe de contrôle
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Le contenu comprend des informations sur les avantages de l'arrêt, du tabagisme et des maladies, les méthodes pour arrêter, la gestion des symptômes de sevrage, la déclaration d'arrêt, etc.
Les conseils de récompense incluent Ask sur les antécédents du tabagisme, mettent en garde contre le risque élevé, conseiller de cesser de fumer, de référer aux fumeurs des services de sevrage tabagique (avec une carte de référence) et de recommencer.
Le contenu comprend des informations brèves et un point culminant des services de sevrage tabagique existants, des méthodes de contact, des informations de motivation et de solides messages ou slogans de soutien.
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and secondhand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking.
Participants in both group will receive a 1-week supply of free nicotine gum (2 mg or 4 mg).
The dosage of nicotine gum will be guided by participants' daily cigarette consumption, in accordance with recommendations from the Department of Health.
Research assistants will explain the benefits of NRT for smoking cessation, provide instructions on the correct use of nicotine gum, encourage participants to continue using nicotine gum after completing the free sample where appropriate, and advise participants to reduce smoking or make a quit attempt when using NRT.
Participants in both groups will receive a brief motivational video (15-second) via WhatsApp.
The video will feature a construction worker who successfully quit smoking in our previous trial, providing a relatable peer role model for participants.
The video will welcome participants to the programme, encourage them to make a quit attempt, and promote early use of nicotine gum as a practical strategy for managing cravings and supporting smoking cessation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Abstinence biochimiquement validée
Délai: Suivi de 6 mois
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Défini comme un niveau de CO expiré < 4 ppm et un niveau de cotinine dans la salive ≤ 30 ng/ml
|
Suivi de 6 mois
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Abstinence biochimiquement validée
Délai: Suivi de 3 mois
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Défini comme un niveau de CO expiré < 4 ppm et un niveau de cotinine dans la salive ≤ 30 ng/ml
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Suivi de 3 mois
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Abstinence autodéclarée de 7 jours à l'abstinence
Délai: Suivi de 3 et 6 mois
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Les fumeurs qui n'ont pas fumé même une bouffée dans les 7 jours précédant le suivi
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Suivi de 3 et 6 mois
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Réduction autodéclarée
Délai: Suivi de 1, 2, 3 et 6 mois
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Défini par au moins 50% de réduction du nombre quotidien de cigarettes de base
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Suivi de 1, 2, 3 et 6 mois
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Utilisation autodéclarée du service de sevrage tabagique
Délai: Suivi de 1, 2, 3 et 6 mois
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Utilisation du service de sevrage tabagique à 1, 2, 3 et 6 mois de suivi.
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Suivi de 1, 2, 3 et 6 mois
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Family well-being
Délai: 3- and 6-month follow-ups
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Family well-being will be assessed using the 3H scale, which measures perceived family health, happiness, and harmony on a 0-10 scale.
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3- and 6-month follow-ups
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Perceived family happiness
Délai: 3- and 6-month follow-ups
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Perceived family happiness will be measured using a single-item self-reported family happiness scale ranging from 0 to 10.
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3- and 6-month follow-ups
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment rate
Délai: Baseline
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Defined as the number of participants divided by the number of eligible smokers
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Baseline
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Retention rate
Délai: 1-, 2-, 3- and 6-month follow-ups
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Defined as the number of participants who completed the follow-up divided by the number of participants
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1-, 2-, 3- and 6-month follow-ups
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Acceptability of NRT sampling
Délai: 1-, 2-, 3- and 6-month follow-ups
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Acceptability of NRT sampling will be assessed through 4 brief items (score range from 0 to10) on perceived usefulness for craving relief, perceived side effects, willingness to continue using NRT after the free sample, and overall satisfaction with the NRT gum.
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1-, 2-, 3- and 6-month follow-ups
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Acceptability of chewing gum
Délai: 1-, 2-, 3- and 6-month follow-ups
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Acceptability of chewing gum will be assessed through 3 brief items (score range from 0 to 10) on perceived usefulness for behavioral substitution, perceived fit with construction worksite routines, and willingness to continue using chewing gum as a cessation aid.
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1-, 2-, 3- and 6-month follow-ups
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Self-reported adverse events
Délai: 1-, 2-, 3- and 6-month follow-ups
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Self-reported adverse events related to nicotine gum and chewing gum will be assessed using a binary question: "Have you experienced any adverse events when using nicotine gum or chewing gum?"
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1-, 2-, 3- and 6-month follow-ups
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Chatbot usability
Délai: 3-month follow-up
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Chatbot usability will be evaluated using the 11-item Bot Usability Scale (BUS), which assesses perceived effectiveness, efficiency, and satisfaction.
The score of the Bot Usability Scale ranges from 0 to 100, with the higher score indicating more usability of the chatbot.
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3-month follow-up
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Man Ping Wang, PhD, The University of Hong Kong
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Comportement
- Comportement de santé
- Sevrage tabagique
- Thérapeutique
- Nourriture
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Nourriture et boissons
- Glucides
- Polymères
- Substances macromoléculaires
- Polysaccharides
- Produits biologiques
- Mélanges complexes
- Biopolymères
- Gommes végétales
- Exsudats de plante
- Bonbons
- Tobacs utilisent des dispositifs de sevrage
- Gomme à mâcher
- Nicotine à mâcher de la gomme
Autres numéros d'identification d'étude
- Build to Quit
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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