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Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke: A Pragmatic, Pilot, Cluster Randomized Controlled Trial

9. juni 2026 opdateret af: Prof. Wang Man-Ping, The University of Hong Kong

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:

  1. 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?
  2. 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:

  1. AWARD advice and brief video
  2. 1-week NRT sampling
  3. 3-week chewing gum
  4. 12-week chatbot-based instant messaging support (via WhatsApp)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Studiesteder

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 999077
        • Hong Kong Council on Smoking and Health (COSH)
        • Kontakt:
          • Fung Wong
          • Telefonnummer: +852 2180 5186
        • Underforsker:
          • Tai Hing Lam, MD
        • Underforsker:
          • Tzu Tsun Luk, PhD
        • Underforsker:
          • Xiaoyun Xie, MPH
        • Underforsker:
          • Mengyao Li, Mphil
        • Underforsker:
          • Ziqiu Guo, PhD
        • Underforsker:
          • Yilan Wu, Mphil

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Hong Kong residents aged 18 or above
  2. Smoke at least one cigarette per day in the preceding 3-month
  3. Able to communicate in Cantonese (including reading and writing Chinese)
  4. Saliva cotinine 30 ng/ml or above
  5. Intent to quit / reduce smoking
  6. Have instant messaging tool (WhatsApp) installed
  7. Able to use instant messaging tool (e.g., WhatsApp) for communication.

Exclusion Criteria:

  1. Smokers who are participating in other smoking cessation programmes
  2. Smokers who are using any smoking cessation medication
  3. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventionsgruppe
Adfærdsmæssigt: Selvhjælps hæfte til rygestop
Indholdet omfatter information om fordelene ved at holde op, ryge og sygdomme, metoder til at holde op, hvordan man håndterer abstinenssymptomer, erklæring om at holde op mv.
Adfærdsmæssigt: Prisrådgivning
Prisrådgivning inkluderer Ask om rygningshistorik, advar om den høje risiko, råd om at stoppe, henvise rygere til rygestop (med et henvisningskort) og gøre det igen.
Adfærdsmæssigt: Henvisningskort
Indholdet består af kort information og et højdepunkt i eksisterende rygestop -tjenester, kontaktmetoder, motivationsinformation og stærke understøttende meddelelser eller slogans.
Adfærdsmæssigt: Brief leaflet on health warning and smoking cessation
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.
Medicin: 1-week nicotine gum
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.
Adfærdsmæssigt: 3-week chewing gum
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.
Adfærdsmæssigt: 12-week chatbot-based instant messaging support
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.
Adfærdsmæssigt: Brief video
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.
Aktiv komparator: Kontrolgruppe
Adfærdsmæssigt: Selvhjælps hæfte til rygestop
Indholdet omfatter information om fordelene ved at holde op, ryge og sygdomme, metoder til at holde op, hvordan man håndterer abstinenssymptomer, erklæring om at holde op mv.
Adfærdsmæssigt: Prisrådgivning
Prisrådgivning inkluderer Ask om rygningshistorik, advar om den høje risiko, råd om at stoppe, henvise rygere til rygestop (med et henvisningskort) og gøre det igen.
Adfærdsmæssigt: Henvisningskort
Indholdet består af kort information og et højdepunkt i eksisterende rygestop -tjenester, kontaktmetoder, motivationsinformation og stærke understøttende meddelelser eller slogans.
Adfærdsmæssigt: Brief leaflet on health warning and smoking cessation
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.
Medicin: 1-week nicotine gum
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.
Adfærdsmæssigt: Brief video
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biokemisk valideret abstinens
Tidsramme: 6 måneders opfølgning
Defineret som udåndet CO-niveau <4ppm og spyt-kotinin-niveau ≤30 ng/ml
6 måneders opfølgning

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biokemisk valideret abstinens
Tidsramme: 3 måneders opfølgning
Defineret som udåndet CO-niveau <4ppm og spyt-kotinin-niveau ≤30 ng/ml
3 måneders opfølgning
Selvrapporteret 7-dages pointudbredelse afholdenhed
Tidsramme: 3- og 6-måneders opfølgning
Rygere, der ikke ryger engang en puff i de 7 dage forud for opfølgningen
3- og 6-måneders opfølgning
Selvrapporteret reduktion
Tidsramme: 1-, 2-, 3- og 6-måneders opfølgning
Defineret ved mindst 50% reduktion i baseline dagligt antal cigaretter
1-, 2-, 3- og 6-måneders opfølgning
Selvrapporteret brug af rygestop-service
Tidsramme: 1-, 2-, 3- og 6-måneders opfølgning
Brug af rygestop-service ved 1-, 2-, 3- og 6-måneders opfølgning.
1-, 2-, 3- og 6-måneders opfølgning
Family well-being
Tidsramme: 3- and 6-month follow-ups
Family well-being will be assessed using the 3H scale, which measures perceived family health, happiness, and harmony on a 0-10 scale.
3- and 6-month follow-ups
Perceived family happiness
Tidsramme: 3- and 6-month follow-ups
Perceived family happiness will be measured using a single-item self-reported family happiness scale ranging from 0 to 10.
3- and 6-month follow-ups

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: Baseline
Defined as the number of participants divided by the number of eligible smokers
Baseline
Retention rate
Tidsramme: 1-, 2-, 3- and 6-month follow-ups
Defined as the number of participants who completed the follow-up divided by the number of participants
1-, 2-, 3- and 6-month follow-ups
Chatbot usability
Tidsramme: 3-month follow-up
Chatbot usability will be evaluated using the 11-item Bot Usability Scale (BUS), which assesses perceived effectiveness, efficiency, and satisfaction.
3-month follow-up
Acceptability of NRT sampling
Tidsramme: 1-, 2-, 3- and 6-month follow-ups
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.
1-, 2-, 3- and 6-month follow-ups
Acceptability of chewing gum
Tidsramme: 1-, 2-, 3- and 6-month follow-ups
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.
1-, 2-, 3- and 6-month follow-ups
Self-reported adverse events
Tidsramme: 1-, 2-, 3- and 6-month follow-ups
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?"
1-, 2-, 3- and 6-month follow-ups

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Hong Kong

Efterforskere

  • Ledende efterforsker: Man Ping Wang, PhD, The University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juni 2026

Primær færdiggørelse (Anslået)

31. maj 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Build to Quit

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