Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this 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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AWARD advice

    Behavioral

    AWARD advice include Ask about smoking history, Warn about the high risk, Advise to quit, Refer smokers to smoking cessation services (with a referral card), and Do it again.

  • Brief leaflet on health warning and smoking cessation

    Behavioral

    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.

  • Referral card

    Behavioral

    The contents consist of brief information and a highlight of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.

  • Self-help smoking cessation booklet

    Behavioral

    The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.

  • 1-week nicotine gum

    Drug

    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.

  • 3-week chewing gum

    Behavioral

    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.

  • 12-week chatbot-based instant messaging support

    Behavioral

    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.

  • Brief video

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 8 interventions
Group B: Control groupActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Biochemically validated abstinence

Defined as exhaled CO level \<4ppm and saliva cotinine level ≤30 ng/ml

Time frame
6-month follow-up

Secondary outcomes

1

Biochemically validated abstinence

Defined as exhaled CO level \<4ppm and saliva cotinine level ≤30 ng/ml

Time frame
3-month follow-up
2

Self-reported 7-day point prevalence abstinence

Smokers who did not smoke even a puff in the 7 days preceding the follow-up

Time frame
3- and 6-month follow-ups
3

Self-reported reduction

Defined by at least 50% reduction in baseline daily number of cigarettes

Time frame
1-, 2-, 3- and 6-month follow-ups
4

Self-reported use of smoking cessation service

Use of smoking cessation service at 1-, 2-, 3- and 6-month follow-ups.

Time frame
1-, 2-, 3- and 6-month follow-ups

Other outcomes

1

Recruitment rate

Defined as the number of participants divided by the number of eligible smokers

Time frame
Baseline
2

Retention rate

Defined as the number of participants who completed the follow-up divided by the number of participants

Time frame
1-, 2-, 3- and 6-month follow-ups
3

Chatbot usability

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.

Time frame
3-month follow-up
4

Acceptability of NRT sampling

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.

Time frame
1-, 2-, 3- and 6-month follow-ups

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: