Smoking CessationNCT03870906
Smoking Cessation Programme in Workplaces in Hong Kong (Phase IV)
A study testing Occupational-specific health talk, WhatsApp interaction 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 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?
- Occupational-specific health talk, WhatsApp interaction 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
- 556 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2019to 31 Mar 2022
- 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 one cigarette per day
- Able to communicate in Cantonese/Mandarin and read Chinese
- Able to use instant messaging tool (e.g. WhatsApp) for communication
- Stay at 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 programme(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Corporate Environment in Promoting Tobacco Control and Evaluation of a Smoking Cessation Programme in Workplaces in Hong Kong
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. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the attitudes and practices of corporations in promoting smoking cessation are not clear. Thus, this study aims to examine the employers'/ managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace and evaluate the smoking behaviors of participants before and after attending a smoking cessation intervention.
Read the detailed description
This study will separate into two phases. Phase I is a large scale cross-sectional survey to corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplace. Phase II is a 2-arm randomized controlled trial will be conducted to examine the effectiveness of WhatsApp intervention.
Outcome:
The primary outcome of the study is to measure participated smokers' self reported 7-day point prevalence quit rate at 6-month follow-up. Secondary outcomes include participated smokers' (i) self reported 7-day point prevalence quit rate at 9- and 12-month follow-ups; (ii) self-reported reduction rate at 6-, 9- and 12-month follow-ups; (iii) self-reported quit attempt at 6-, 9- and 12-month follow-ups; (iv) change in self-efficacy towards smoking cessation at 6-, 9- and 12-month follow-ups compared with baseline.
Data analyses
Phase I:
Descriptive statistics will be used to measure the (1) basic information of the corporations, including the total number of employees and smoking employees; (2) knowledge on smoking of employers/managerial staff; (3) attitudes on smoking cessation of employers/managerial staff; (4) practices of the corporations with respect to smoking cessation.
Phase II:
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 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. Subgroup analyses will be conducted among the "adherence" cohort, which is classified as subjects who actively participant in the WhatsApp interaction.
- Conditions
- Smoking Cessation
- Being tested
- Occupational-specific health talk, WhatsApp interaction, Phone follow-up/counselling service, 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.
Occupational-specific health talkBehavioural
Health talk will provide information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
WhatsApp interactionBehavioural
Individual WhatsApp interactions last 3-month and consist of 2 parts. First part is regular WhatsApp message. The schedule will be adjusted according to the participants' quitting status. Second part is real-time discussion intervention based on participants' socio-demographic characteristics, smoking habit at baseline and updated smoking status obtained during online conversation. At 3-month follow-up, participants who are still smoking are encouraged to join an additional 1-month online group chat moderated by a smoking cessation counselor.
Phone follow-up/counselling serviceBehavioural
The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
Text messageBiological
Participants will receive regular text messages with similar frequency to those in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| WhatsApp interaction | Experimental | Individual and group chat interactions. Receives: Behavioral: Occupational-specific health talk; Behavioral: WhatsApp interaction; Behavioral: Phone follow-up/counselling service |
| Text message | Placebo comparator | Regular text messages with similar frequency to those in the Intervention group. Receives: Behavioral: Occupational-specific health talk; Behavioral: Phone follow-up/counselling service; Biological: Text message |
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 (3)
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- and 12-month
Self-reported reduction rate
Smokers' who reduced tobacco use (in term of daily cigarette consumption) in the follow-up when comparing with the baseline
Measured: 6-, 9-, and 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
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
- 556 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870906
- Sponsor's protocol ID
- LST SCPW P4
- Status last verified
- May 2023
- First submitted
- 10 Mar 2019
- Last updated
- 22 May 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 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Corporate Environment in Promoting Tobacco Control and Evaluation of a Smoking Cessation Programme in Workplaces in Hong Kong
- ClinicalTrials.gov ID
- NCT03870906
- Acronym / sponsor ID
- LST SCPW P4
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Lok Sin Tong Benevolent Society, Kowloon
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 12 Mar 2019 (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. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the attitudes and practices of corporations in promoting smoking cessation are not clear. Thus, this study aims to examine the employers'/ managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace and evaluate the smoking behaviors of participants before and after attending a smoking cessation intervention.
Detailed description
This study will separate into two phases. Phase I is a large scale cross-sectional survey to corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplace. Phase II is a 2-arm randomized controlled trial will be conducted to examine the effectiveness of WhatsApp intervention.
Outcome:
The primary outcome of the study is to measure participated smokers' self reported 7-day point prevalence quit rate at 6-month follow-up. Secondary outcomes include participated smokers' (i) self reported 7-day point prevalence quit rate at 9- and 12-month follow-ups; (ii) self-reported reduction rate at 6-, 9- and 12-month follow-ups; (iii) self-reported quit attempt at 6-, 9- and 12-month follow-ups; (iv) change in self-efficacy towards smoking cessation at 6-, 9- and 12-month follow-ups compared with baseline.
Data analyses
Phase I:
Descriptive statistics will be used to measure the (1) basic information of the corporations, including the total number of employees and smoking employees; (2) knowledge on smoking of employers/managerial staff; (3) attitudes on smoking cessation of employers/managerial staff; (4) practices of the corporations with respect to smoking cessation.
Phase II:
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 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. Subgroup analyses will be conducted among the "adherence" cohort, which is classified as subjects who actively participant in the WhatsApp interaction.
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 |
|---|---|---|
| WhatsApp interaction | Experimental | Behavioral: Occupational-specific health talk, Behavioral: WhatsApp interaction, Behavioral: Phone follow-up/counselling serviceIndividual and group chat interactions. |
| Text message | Placebo comparator | Behavioral: Occupational-specific health talk, Behavioral: Phone follow-up/counselling service, Biological: Text messageRegular text messages with similar frequency to those in the Intervention 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
- Smoke at least one cigarette per day
- Able to communicate in Cantonese/Mandarin and read Chinese
- Able to use instant messaging tool (e.g. WhatsApp) for communication
- Stay at Hong Kong during the intervention and follow-up periods (12 months)
Key exclusion criteria (2 listed)
- Smokers who are psychologically or physically unable to communicate
- Currently following other smoking cessation programme(s)
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 |
|---|---|---|
| Occupational-specific health talkHealth talk will provide information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking. | Behavioural | Text message, WhatsApp interaction |
| WhatsApp interactionIndividual WhatsApp interactions last 3-month and consist of 2 parts. First part is regular WhatsApp message. The schedule will be adjusted according to the participants' quitting status. Second part is real-time discussion intervention based on participants' socio-demographic characteristics, smoking habit at baseline and updated smoking status obtained during online conversation. At 3-month follow-up, participants who are still smoking are encouraged to join an additional 1-month online group chat moderated by a smoking cessation counselor. | Behavioural | WhatsApp interaction |
| Phone follow-up/counselling serviceThe intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes). | Behavioural | Text message, WhatsApp interaction |
| Text messageParticipants will receive regular text messages with similar frequency to those in the intervention group. | Biological | Text message |
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
3 secondary outcomes
Self-reported 7-day point prevalence quit rate
Time frame: 9- and 12-month
Self-reported reduction rate
Time frame: 6-, 9-, and 12-month
Biochemical validation of smoking status
Time frame: 6-, 9-, and 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational-specific health talk, WhatsApp interaction 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 2 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: finished, as of the sponsor's last update on 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 22 May 2023.