Smoking CessationNCT06932718
Smoking Cessation Programme in Workplaces in Hong Kong (Phase ⅤII)
A study testing General health talk, Personalized chat-based interactions and Phone follow-up/counselling service in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Smoking cessation (SC) interventions using behavioral economics mainly focus on financial incentives, which were used to change health behaviors by utilizing a reward system to enhance long-term maintenance. Incentives have been demonstrated to enhance SC across various populations with moderate effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- General health talk, Personalized chat-based interactions and Phone follow-up/counselling service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Mar 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 or above
- Current smoking cigarettes or alternative tobacco products daily with an exhaled carbon monoxide level ≥4 ppm or a positive salivary cotinine test
- Able to communicate in Cantonese/Mandarin and read Chinese
- Able to use instant messaging tool (e.g. WhatsApp) for communication.
- Stay in Hong Kong during the intervention and follow-up periods (12 months)
Who cannot join
- Smokers who are psychologically or physically unable to communicate
- Currently following other SC program(s)
- Having used NRT for the past month
- Having severe angina, serious cardiac arrhythmias and hypertension
- Have acute myocardial event in the past month
- Being pregnant or providing breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The University of Hong Kong
Hong Kong
Man Ping Wang, 85239176636, mpwang@hku.hk
Yilan Wu, 85256497578, visspalan@connect.hku.hk
About this study
Official title: Evaluation of a Smoking Cessation Program in Workplaces in Hong Kong: a Pragmatic Randomized Controlled Trial on Mobile Phone-Based Intervention Combined With Small Incentive for Smoking Cessation
Smoking cessation (SC) interventions using behavioral economics mainly focus on financial incentives, which were used to change health behaviors by utilizing a reward system to enhance long-term maintenance. Incentives have been demonstrated to enhance SC across various populations with moderate effects. Interventions for smoking cessation characterized by financial incentives focus primarily on the potential for monetary gain rather than loss. Changing the motivational strategy to combine disclosing losses with providing financial incentives may increase the effectiveness of financial consequence-based smoking cessation interventions. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention combined with small incentive and smoking cessation in workplaces in Hong Kong; identify facilitators and barriers of successful policy implementation and quitting; examine and evaluate the company environment and their policies in promoting smoking cessation.
Read the detailed description
This study will separate into two phases. Phase I is a large scale cross-sectional survey of corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting SC in the workplace. Phase II is a 2-arm randomized controlled trial that will be conducted to examine the effectiveness of mobile phone-based intervention combined with company health talk, brief phone counselling and nicotine replacement therapy sampling, for SC in workplaces.
Data analyses Phase I: Descriptive statistics will be used to analyze the (1) profile of the corporations, including the total number of employees and smoking employees; (2) employers/managerial staff's knowledge on smoking; (3) employers/managerial staff's attitudes on smoking cessation; (4) practices of the companies with respect to smoking cessation.
Phase II: Primary outcome is self-reported abstinence in the past 7 days at 6-month follow-up. Secondary outcomes for smoking cessation include self-reported abstinence in the past 7 days at 9- and 12-month follow-ups, the biochemically validated abstinence (defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml); smoking reduction (50% or above reduction in cigarette consumption compared with baseline. Secondary outcomes for mental health include stress (Perceived Stress Scale-10), depression (Personal Health Questionnaire for Depression), anxiety (Generalized Anxiety Disorder scale) and self-rated health.
Descriptive statistics such as frequency, percentage, and mean will be used to summarize the outcomes and other variables. Chi-square tests and t-tests will be used to compare outcome variables between subgroups. The intention-to-treat (ITT) analysis will be used such that those lost to contact and refused cases at the follow-ups will be treated as no reduction in cigarette consumption nor quitting. Multiple imputations will be used to compute missing data for outcome variables. The association between intervention adherence (e.g., engagement in the IM interaction) and the primary outcome within the participants in the intervention group will be examined. The intervention effect by subgroups will be assessed respectively, including sex, age, education level, company types, previous quit attempts, cigarette dependence, and intention to quit, although the statistical power would be lower due to smaller numbers.
- Conditions
- Smoking Cessation
- Being tested
- General health talk, Personalized chat-based interactions, Phone follow-up/counselling service, Mailed nicotine replacement therapy (NRT), Text message
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General health talkBehavioural
Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
Personalized chat-based interactionsBehavioural
Individual chat-based interactions for 3 months consist of 2 parts. The first part includes regular messages via instant messages (IM). These messages will serve as probes for real-time chat-based support in which more details explanations and motivation to encourage quitting due to financial reasons. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using health economic principles on behavioral change to motivate smokers to quit. The conversation is based on participants' socio-demographic characteristics, smoking habit at baseline, and updated smoking status and mental health status assessed during online conversation and the baseline questionnaire.
Phone follow-up/counselling serviceBehavioural
The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
Mailed nicotine replacement therapy (NRT)Drug
Full course of NRT treatment (10 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics.
Text messageBehavioural
Regular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups.
Small incentiveOther
Positive incentive was reported to be effective in reducing smoking. Participants in the intervention group will receive HK$ 100 at 3-month follow-up. HK$ 500 will be provided to successful quitters confirmed by biochemical validation at 6 months. A total of HK$ 600 maximum will be rewarded to the participants. The amount of the incentive is comparable to other community events on smoking cessation in Hong Kong. Of note, all smokers who reported quitting, completed and passed the biochemical validation of quitting had been offered HK$ 500 in the past rounds and will also be adopted in this round.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Personalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group Receives: Behavioral: General health talk; Behavioral: Personalized chat-based interactions; Behavioral: Phone follow-up/counselling service; Drug: Mailed nicotine replacement therapy (NRT); Other: Small incentive |
| Control | Placebo comparator | Regular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group Receives: Behavioral: General health talk; Behavioral: Phone follow-up/counselling service; Drug: Mailed nicotine replacement therapy (NRT); Behavioral: Text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical validation of smoking status
Biochemical validated abstinence (exhaled CO level <4 ppm or a positive salivary cotinine test)
Measured: 6-month
Secondary outcomes (4)
Self-reported 7-day point prevalence quit rate
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
Measured: 1-, 3- and 12-month
Biochemical validation of smoking status
Biochemically validated quit rate (saliva cotinine level and exhale carbon monoxide test)
Measured: 12-month
Self-reported reduction cigarette rate
Smoking reduction (50% or above reduction in cigarette consumption compared with baseline).
Measured: 1-, 3-, 6- and 12-month
Self-reported use of nicotine replacement therapy (NRT)
Self-reported use of NRT products (e.g., gum and patches)
Measured: 1-, 3-, 6- and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start18 Mar 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Lok Sin Tong Benevolent Society, Kowloon
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932718
- Sponsor's protocol ID
- LST SCPW P7
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smoking Cessation Program in Workplaces in Hong Kong: a Pragmatic Randomized Controlled Trial on Mobile Phone-Based Intervention Combined With Small Incentive for Smoking Cessation
- ClinicalTrials.gov ID
- NCT06932718
- Acronym / sponsor ID
- LST SCPW P7
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Lok Sin Tong Benevolent Society, Kowloon
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking cessation (SC) interventions using behavioral economics mainly focus on financial incentives, which were used to change health behaviors by utilizing a reward system to enhance long-term maintenance. Incentives have been demonstrated to enhance SC across various populations with moderate effects. Interventions for smoking cessation characterized by financial incentives focus primarily on the potential for monetary gain rather than loss. Changing the motivational strategy to combine disclosing losses with providing financial incentives may increase the effectiveness of financial consequence-based smoking cessation interventions. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention combined with small incentive and smoking cessation in workplaces in Hong Kong; identify facilitators and barriers of successful policy implementation and quitting; examine and evaluate the company environment and their policies in promoting smoking cessation.
Detailed description
This study will separate into two phases. Phase I is a large scale cross-sectional survey of corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting SC in the workplace. Phase II is a 2-arm randomized controlled trial that will be conducted to examine the effectiveness of mobile phone-based intervention combined with company health talk, brief phone counselling and nicotine replacement therapy sampling, for SC in workplaces.
Data analyses Phase I: Descriptive statistics will be used to analyze the (1) profile of the corporations, including the total number of employees and smoking employees; (2) employers/managerial staff's knowledge on smoking; (3) employers/managerial staff's attitudes on smoking cessation; (4) practices of the companies with respect to smoking cessation.
Phase II: Primary outcome is self-reported abstinence in the past 7 days at 6-month follow-up. Secondary outcomes for smoking cessation include self-reported abstinence in the past 7 days at 9- and 12-month follow-ups, the biochemically validated abstinence (defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml); smoking reduction (50% or above reduction in cigarette consumption compared with baseline. Secondary outcomes for mental health include stress (Perceived Stress Scale-10), depression (Personal Health Questionnaire for Depression), anxiety (Generalized Anxiety Disorder scale) and self-rated health.
Descriptive statistics such as frequency, percentage, and mean will be used to summarize the outcomes and other variables. Chi-square tests and t-tests will be used to compare outcome variables between subgroups. The intention-to-treat (ITT) analysis will be used such that those lost to contact and refused cases at the follow-ups will be treated as no reduction in cigarette consumption nor quitting. Multiple imputations will be used to compute missing data for outcome variables. The association between intervention adherence (e.g., engagement in the IM interaction) and the primary outcome within the participants in the intervention group will be examined. The intervention effect by subgroups will be assessed respectively, including sex, age, education level, company types, previous quit attempts, cigarette dependence, and intention to quit, although the statistical power would be lower due to smaller numbers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: General health talk, Behavioral: Personalized chat-based interactions, Behavioral: Phone follow-up/counselling service, Drug: Mailed nicotine replacement therapy (NRT), Other: Small incentivePersonalized chat-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for intervention group |
| Control | Placebo comparator | Behavioral: General health talk, Behavioral: Phone follow-up/counselling service, Drug: Mailed nicotine replacement therapy (NRT), Behavioral: Text messageRegular text-based support and nicotine replacement therapy sampling (NRT-S) for continued smokers at 6 months for control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents aged 18 or above
- Current smoking cigarettes or alternative tobacco products daily with an exhaled carbon monoxide level ≥4 ppm or a positive salivary cotinine test
- Able to communicate in Cantonese/Mandarin and read Chinese
- Able to use instant messaging tool (e.g. WhatsApp) for communication.
- Stay in Hong Kong during the intervention and follow-up periods (12 months)
Key exclusion criteria (6 listed)
- Smokers who are psychologically or physically unable to communicate
- Currently following other SC program(s)
- Having used NRT for the past month
- Having severe angina, serious cardiac arrhythmias and hypertension
- Have acute myocardial event in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General health talkHealth talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking. | Behavioural | Control, Intervention |
| Personalized chat-based interactionsIndividual chat-based interactions for 3 months consist of 2 parts. The first part includes regular messages via instant messages (IM). These messages will serve as probes for real-time chat-based support in which more details explanations and motivation to encourage quitting due to financial reasons. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using health economic principles on behavioral change to motivate smokers to quit. The conversation is based on participants' socio-demographic characteristics, smoking habit at baseline, and updated smoking status and mental health status assessed during online conversation and the baseline questionnaire. | Behavioural | Intervention |
| Phone follow-up/counselling serviceThe intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes). | Behavioural | Control, Intervention |
| Mailed nicotine replacement therapy (NRT)Full course of NRT treatment (10 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics. | Drug | Control, Intervention |
| Text messageRegular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups. | Behavioural | Control |
| Small incentivePositive incentive was reported to be effective in reducing smoking. Participants in the intervention group will receive HK$ 100 at 3-month follow-up. HK$ 500 will be provided to successful quitters confirmed by biochemical validation at 6 months. A total of HK$ 600 maximum will be rewarded to the participants. The amount of the incentive is comparable to other community events on smoking cessation in Hong Kong. Of note, all smokers who reported quitting, completed and passed the biochemical validation of quitting had been offered HK$ 500 in the past rounds and will also be adopted in this round. | Other | Intervention |
Primary outcome
Biochemical validation of smoking status
Time frame: 6-month
Biochemical validated abstinence (exhaled CO level <4 ppm or a positive salivary cotinine test)
4 secondary outcomes
Self-reported 7-day point prevalence quit rate
Time frame: 1-, 3- and 12-month
Biochemical validation of smoking status
Time frame: 12-month
Self-reported reduction cigarette rate
Time frame: 1-, 3-, 6- and 12-month
Self-reported use of nicotine replacement therapy (NRT)
Time frame: 1-, 3-, 6- and 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Man Ping Wang principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General health talk, Personalized chat-based interactions and Phone follow-up/counselling service in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man Ping Wang (85239176636, mpwang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical validation of smoking status (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.