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- Klinische proef 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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Gedragsmatig: Zelfhulpboekje stoppen met roken
- Gedragsmatig: Advies
- Gedragsmatig: Verwijzingskaart
- Gedragsmatig: Brief leaflet on health warning and smoking cessation
- Geneesmiddel: 1-week nicotine gum
- Gedragsmatig: 3-week chewing gum
- Gedragsmatig: 12-week chatbot-based instant messaging support
- Gedragsmatig: Brief video
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Man Ping Wang, PhD
- Telefoonnummer: +852 3917 6636
- E-mail: mpwang@hku.hk
Studie Contact Back-up
- Naam: Mengyao Li, Mphil
- Telefoonnummer: +852 6851 8462
- E-mail: lmy0814@connect.hku.hk
Studie Locaties
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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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Contact:
- Fung Wong
- Telefoonnummer: +852 2180 5186
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Onderonderzoeker:
- Tai Hing Lam, MD
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Onderonderzoeker:
- Tzu Tsun Luk, PhD
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Onderonderzoeker:
- Xiaoyun Xie, MPH
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Onderonderzoeker:
- Mengyao Li, Mphil
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Onderonderzoeker:
- Ziqiu Guo, PhD
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Onderonderzoeker:
- Yilan Wu, Mphil
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Interventie groep
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De inhoud omvat informatie over de voordelen van stoppen, roken en ziektes, methoden om te stoppen, hoe om te gaan met ontwenningsverschijnselen, verklaring van stoppen, enz.
Award -advies omvatten vraag over de rookgeschiedenis, waarschuw voor het hoge risico, adviseren om te stoppen, verwijzen rokers naar het stoppen met roken (met een verwijzingskaart) en doe dit opnieuw.
De inhoud bestaat uit korte informatie en een hoogtepunt van bestaande stopzettingsdiensten, contactmethoden, motivatie -informatie en sterke ondersteunende berichten of slogans.
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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Actieve vergelijker: Controlegroep
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De inhoud omvat informatie over de voordelen van stoppen, roken en ziektes, methoden om te stoppen, hoe om te gaan met ontwenningsverschijnselen, verklaring van stoppen, enz.
Award -advies omvatten vraag over de rookgeschiedenis, waarschuw voor het hoge risico, adviseren om te stoppen, verwijzen rokers naar het stoppen met roken (met een verwijzingskaart) en doe dit opnieuw.
De inhoud bestaat uit korte informatie en een hoogtepunt van bestaande stopzettingsdiensten, contactmethoden, motivatie -informatie en sterke ondersteunende berichten of slogans.
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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Biochemisch gevalideerde onthouding
Tijdsspanne: 6 maanden follow-up
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Gedefinieerd als uitgeademd CO-gehalte <4ppm en speeksel-cotininegehalte ≤30 ng/ml
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6 maanden follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Biochemisch gevalideerde onthouding
Tijdsspanne: 3 maanden follow-up
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Gedefinieerd als uitgeademd CO-gehalte <4ppm en speeksel-cotininegehalte ≤30 ng/ml
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3 maanden follow-up
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Zelf gerapporteerde 7-daagse prevalentie onthouding
Tijdsspanne: 3- en 6-maanden follow-ups
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Rokers die zelfs geen trek rookten in de 7 dagen voorafgaand aan de follow-up
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3- en 6-maanden follow-ups
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Zelfgerapporteerde reductie
Tijdsspanne: 1-, 2-, 3- en 6-maanden follow-ups
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Gedefinieerd door ten minste 50% vermindering van het dagelijkse dagelijkse aantal sigaretten
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1-, 2-, 3- en 6-maanden follow-ups
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Zelfgerapporteerd gebruik van het stoppen met roken
Tijdsspanne: 1-, 2-, 3- en 6-maanden follow-ups
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Gebruik van het stoppen met roken bij follow-ups van 1-, 2-, 3- en 6 maanden.
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1-, 2-, 3- en 6-maanden follow-ups
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Family well-being
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Recruitment rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Man Ping Wang, PhD, The University of Hong Kong
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Gedrag
- Gezondheidsgedrag
- Stoppen met roken
- Therapeutica
- Voedsel
- Dieet, voedsel en voeding
- Fysiologische fenomenen
- Eten en dranken
- Koolhydraten
- Polymeren
- Macromoleculaire stoffen
- Polysachariden
- Biologische producten
- Complexe mengsels
- Biopolymeren
- Plantengom
- Plant exsudeert
- Snoep
- Tabaksgebruik -apparaten gebruiken
- Kauwgom
- Nicotine kauwgom
Andere studie-ID-nummers
- Build to Quit
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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