- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Man Ping Wang, PhD
- Telefonnummer: +852 3917 6636
- E-post: mpwang@hku.hk
Studera Kontakt Backup
- Namn: Mengyao Li, Mphil
- Telefonnummer: +852 6851 8462
- E-post: lmy0814@connect.hku.hk
Studieorter
-
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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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Kontakt:
- Fung Wong
- Telefonnummer: +852 2180 5186
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Underutredare:
- Tai Hing Lam, MD
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Underutredare:
- Tzu Tsun Luk, PhD
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Underutredare:
- Xiaoyun Xie, MPH
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Underutredare:
- Mengyao Li, Mphil
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Underutredare:
- Ziqiu Guo, PhD
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Underutredare:
- Yilan Wu, Mphil
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Insatsgrupp
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Innehållet innehåller bland annat information om fördelarna med att sluta, röka och sjukdomar, metoder för att sluta, hur man hanterar abstinensbesvär, förklaring om att sluta m.m.
Prisutdelar inkluderar fråga om rökhistoria, varna för den höga risken, rekommendera att sluta, hänvisa rökare till rökavvänjningstjänster (med ett remisskort) och göra det igen.
Innehållet består av kort information och en höjdpunkt i befintliga rökavvänjningstjänster, kontaktmetoder, motivationsinformation och starka stödmeddelanden eller slagord.
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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Aktiv komparator: Kontrollgrupp
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Innehållet innehåller bland annat information om fördelarna med att sluta, röka och sjukdomar, metoder för att sluta, hur man hanterar abstinensbesvär, förklaring om att sluta m.m.
Prisutdelar inkluderar fråga om rökhistoria, varna för den höga risken, rekommendera att sluta, hänvisa rökare till rökavvänjningstjänster (med ett remisskort) och göra det igen.
Innehållet består av kort information och en höjdpunkt i befintliga rökavvänjningstjänster, kontaktmetoder, motivationsinformation och starka stödmeddelanden eller slagord.
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Biokemiskt validerad abstinens
Tidsram: 6 månaders uppföljning
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Definierat som utandad CO-nivå <4ppm och salivkotininnivå ≤30 ng/ml
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6 månaders uppföljning
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Biokemiskt validerad abstinens
Tidsram: 3 månaders uppföljning
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Definierat som utandad CO-nivå <4ppm och salivkotininnivå ≤30 ng/ml
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3 månaders uppföljning
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Självrapporterad 7-dagars prevalensavhållighet
Tidsram: 3- och 6-månaders uppföljningar
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Rökare som inte röker ens en puff under de sju dagarna före uppföljningen
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3- och 6-månaders uppföljningar
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Självrapporterad minskning
Tidsram: 1-, 2-, 3- och 6-månaders uppföljningar
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Definieras av minst 50% minskning av baslinjen dagligen antal cigaretter
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1-, 2-, 3- och 6-månaders uppföljningar
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Självrapporterad användning av rökavvänjningstjänst
Tidsram: 1-, 2-, 3- och 6-månaders uppföljningar
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Användning av rökavvänjningstjänst vid 1-, 2-, 3- och 6-månaders uppföljningar.
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1-, 2-, 3- och 6-månaders uppföljningar
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Family well-being
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Recruitment rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Man Ping Wang, PhD, The University of Hong Kong
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Beteende
- Hälsobeteende
- Rökavvänjning
- Terapeutik
- Mat
- Diet, mat och näring
- Fysiologiska fenomen
- Mat och dryck
- Kolhydrater
- Polymerer
- Makromolekylära ämnen
- Polysackarider
- Biologiska produkter
- Komplexa blandningar
- Biopolymerer
- Gummis
- Anläggningsutsöndringar
- Godis
- Tobak använder upphörande enheter
- Tuggummi
- Nikotin tuggummi
Andra studie-ID-nummer
- Build to Quit
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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