Smoking CessationNCT04772521
Smoking Cessation Programme in Workplaces in Hong Kong (Phase Ⅴ)
A study testing General health talk, Personalized chat-based interactions and Text message in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Smoking causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been a leading risk factor for death globally. Despite the availability of smoking cessation services locally, most smokers do not use such services. 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 Text message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Smoke at least 1 cigarette per day or use e-cigarette (EC) or heated tobacco product (HTP) daily
- PSS-4 score ≥ 6, or GAD-2 score≥ 3, or PHQ-2 score≥ 3
- 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 smoking cessation program(s)
- Smokers who have severe mental illness
Trial locations and contacts
1 site in 1 country.
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 on Smoking Cessation and Reducing Mental Health Symptoms
Smoking causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been a leading risk factor for death globally. Despite the availability of smoking cessation services locally, most smokers do not use such services. Workplace is one of the most convenient platforms to provide smoking cessation services and over 55% of smokers are employed according to the local population-based survey. Moreover, The COVID-19 pandemic and new normal increase in mental health burden to people in the workplace. An online survey during the pandemic found 88% of Hong Kong employees suffered from stress at work during the past 7 days. Mental health can be both precursors and consequences of smoking. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the mental health support for smoking employees in promoting smoking cessation is not clear. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention on reducing mental health symptoms 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, Text message, Phone follow-up/counselling service, Mailed nicotine replacement therapy (NRT)
- 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 last 3 months and consist of 2 parts. First part is regular message. The schedule will be adjusted according to the participants' quitting and mental health status. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using the acceptance and commitment therapy (ACT) model for smoking cessation and reliving mental health problems. 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.
Text messageBehavioural
Regular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups.
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
Also called NRT
Full course of NRT treatment (8 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.
| 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) |
| 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: Text message; Behavioral: Phone follow-up/counselling service; Drug: Mailed nicotine replacement therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 6-month
Secondary outcomes (7)
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: 9-,12-month
Biochemical validation of smoking status
Biochemically validated quit rate (saliva cotinine level and exhale carbon monoxide test)
Measured: 6-, 9-, and 12-month
Self-reported reduction cigarette rate
smoking reduction (50% or above reduction in cigarette consumption compared with baseline).
Measured: 6-, 9-, and 12-month
Self-reported perceived stress
Stress will be assessed by Perceived Stress Scale-4 (PSS-4). It reports perceived stress in the past month on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Individual scores on the PSS can range from 0 to 16 with higher scores indicating higher perceived stress.
Measured: 6-, 9-, and 12-month
Self-reported depression symptoms
Depression will be assessed by Personal Health Questionnaire for Depression-2 (PHQ-2). The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. A PHQ-2 score ranges from 0-6. If the score is 3 or greater, major depressive disorder is likely.
Measured: 6-, 9-, and 12-month
Self-reported anxiety symptoms
Anxiety will be assessed by Generalized Anxiety Disorder-2 (GAD-2). The GAD-2 is a very brief and easy to perform initial screening tool for generalized anxiety. A GAD-2 score ranges from 0-6. If the score is 3 or greater, generalized anxiety disorder is likely.
Measured: 6-, 9-, and 12-month
Self-rated health
Self-rated health will be measured as a single-item with the response items "excellent," "very good," "good," "fair," or "poor."
Measured: 6-, 9-, 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 posted26 Feb 2021
- Study start15 Apr 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
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, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772521
- Sponsor's protocol ID
- LST SCPW P5
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2021
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. 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 on Smoking Cessation and Reducing Mental Health Symptoms
- ClinicalTrials.gov ID
- NCT04772521
- Acronym / sponsor ID
- LST SCPW P5
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Lok Sin Tong Benevolent Society, Kowloon
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 Feb 2021 (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 causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been a leading risk factor for death globally. Despite the availability of smoking cessation services locally, most smokers do not use such services. Workplace is one of the most convenient platforms to provide smoking cessation services and over 55% of smokers are employed according to the local population-based survey. Moreover, The COVID-19 pandemic and new normal increase in mental health burden to people in the workplace. An online survey during the pandemic found 88% of Hong Kong employees suffered from stress at work during the past 7 days. Mental health can be both precursors and consequences of smoking. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the mental health support for smoking employees in promoting smoking cessation is not clear. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention on reducing mental health symptoms 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
- Single blind (outcomes assessor)
- 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)Personalized 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: Text message, Behavioral: Phone follow-up/counselling service, Drug: Mailed nicotine replacement therapy (NRT)Regular 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 (6 listed)
- Hong Kong residents aged 18 or above
- Smoke at least 1 cigarette per day or use e-cigarette (EC) or heated tobacco product (HTP) daily
- PSS-4 score ≥ 6, or GAD-2 score≥ 3, or PHQ-2 score≥ 3
- Able to communicate in Cantonese/Mandarin and read Chinese
- Able to use instant messaging tool (e.g. WhatsApp) for communication.
Key exclusion criteria (3 listed)
- Smokers who are psychologically or physically unable to communicate
- Currently following other smoking cessation program(s)
- Smokers who have severe mental illness
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 last 3 months and consist of 2 parts. First part is regular message. The schedule will be adjusted according to the participants' quitting and mental health status. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using the acceptance and commitment therapy (ACT) model for smoking cessation and reliving mental health problems. 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 |
| 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 |
| 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)Also: NRTFull course of NRT treatment (8 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 |
Primary outcome
Self-reported 7-day point prevalence quit rate
Time frame: 6-month
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
7 secondary outcomes
Self-reported 7-day point prevalence quit rate
Time frame: 9-,12-month
Biochemical validation of smoking status
Time frame: 6-, 9-, and 12-month
Self-reported reduction cigarette rate
Time frame: 6-, 9-, and 12-month
Self-reported perceived stress
Time frame: 6-, 9-, and 12-month
Self-reported depression symptoms
Time frame: 6-, 9-, and 12-month
Self-reported anxiety symptoms
Time frame: 6-, 9-, and 12-month
Self-rated health
Time frame: 6-, 9-, and 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Man Ping Wang, PhD 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 Text message 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 7-day point prevalence quit rate (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 8 Dec 2023.