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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
AWARD advice
BehavioralAWARD 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
BehavioralThe 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
BehavioralThe 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
BehavioralThe 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
DrugParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
Trial outcomes
Primary outcomes
Biochemically validated abstinence
Defined as exhaled CO level \<4ppm and saliva cotinine level ≤30 ng/ml
Secondary outcomes
Biochemically validated abstinence
Defined as exhaled CO level \<4ppm and saliva cotinine level ≤30 ng/ml
Self-reported 7-day point prevalence abstinence
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
Self-reported reduction
Defined by at least 50% reduction in baseline daily number of cigarettes
Self-reported use of smoking cessation service
Use of smoking cessation service at 1-, 2-, 3- and 6-month follow-ups.
Other outcomes
Recruitment rate
Defined as the number of participants divided by the number of eligible smokers
Retention rate
Defined as the number of participants who completed the follow-up divided by the number of participants
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.
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.
Sponsors and contacts
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