SmokingNCT02659774
Smoking Cessation in Workplaces in Hong Kong [Phase II]
A study testing workshop (Motivational intervention), Health talk and Face to Face counseling in people with Smoking, run by The University of Hong Kong at 1 site in China.
Trial summary
This study has the following objectives: 1. To examine the employers'/managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace. 2. To evaluate the smoking behaviours of participants before and after attending a smoking cessation intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- workshop (Motivational intervention), Health talk and Face to Face counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 or above
- Cantonese speaker and able to read in Chinese characters
- Smoke at least one cigarette per day
- 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
- Smokers who are currently following other smoking cessation programme(s)
- Smokers with diagnosed psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
China1 site
2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society
Hong Kong
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
This study has the following objectives:
- To examine the employers'/managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace.
- To evaluate the smoking behaviours of participants before and after attending a smoking cessation intervention.
Read the detailed description
Study design In Phase I of this study, a large scale cross-sectional survey will be sent to 3000 corporations in Hong Kong. The questionnaire will examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplace.
In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a smoking cessation intervention offered by the Department of Psychology, the University of Hong Kong. A total of 600 smokers from corporations will be recruited and interviewed before the intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and 52-week post-intervention follow-ups, in an attempt to evaluate their smoking behaviours, knowledge on smoking and satisfaction of the smoking cessation services. Self-reported quitters (did not smoke in the past 7 days) will be invited to participate in the bio-chemical validation by assessing their exhaled carbon monoxide level and the saliva cotinine level.
Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group will be conducted within 1 month after 12-month follow-up.
- Conditions
- Smoking
- Being tested
- workshop (Motivational intervention), Health talk, Face to Face counseling, Phone counseling, SMS
- Keywords
- Smoking cessation interventions
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workshop (Motivational intervention)Behavioural
Through intensive workshop which includes motivation of quitting enhancement, stress management, smoking triggers, cravings and relapse, to provide smoking cessation intervention
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
Face to Face counselingBehavioural
Use motivational interview strategies through face-to-face counseling to provide smoking cessation intervention
Phone counselingBehavioural
Use motivational interview strategies through telephone counseling to provide smoking cessation intervention
SMSBehavioural
Use motivational interview strategies through telephone messages to provide smoking cessation intervention
BookletBehavioural
A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS) Receives: Behavioral: workshop (Motivational intervention); Behavioral: Health talk; Behavioral: SMS; Behavioral: Booklet |
| Group B | Placebo comparator | Face to Face counseling (Motivational intervention) + Booklet + SMS Receives: Behavioral: Health talk; Behavioral: Face to Face counseling; Behavioral: SMS; Behavioral: Booklet |
| Group C | Placebo comparator | Phone counseling (Motivational intervention) + Health talk + booklet + SMS Receives: Behavioral: Health talk; Behavioral: SMS; Behavioral: Booklet |
| Group D | Placebo comparator | Phone counseling (Motivational intervention) + booklet + SMS Receives: Behavioral: Phone counseling; Behavioral: SMS; Behavioral: Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline smoking quit rate at 6-month
Quit smoking rate is defined by the self-reported 7-day point prevalence abstinence. It is a binary type (yes/no) questionnaire and participants answer the question about their smoking status in the past 7 days at 6-month after the intervention.
Measured: 6 months after the intervention
Secondary outcomes (3)
Change from baseline smoking reduction at 6-month
Smoking reduction is defined as reduced at least 50% of cigarette consumption. Participants were asked to respond to the daily cigarette consumption at 6-month after the intervention. Their daily cigarette consumption at 6-month were compared with baseline's daily cigarette consumption and determine whether they had reduced at least 50% cigarette consumption at 6-month.
Measured: 6 months after the intervention
Change from baseline smoking reduction at 12-month
Smoking reduction is defined as reduced at least 50% of cigarette consumption. Participants were asked to respond to the daily cigarette consumption at 6-month after the intervention. Their daily cigarette consumption at 12-month were compared with baseline's daily cigarette consumption and determine whether they had reduced at least 50% cigarette consumption at 12-month.
Measured: 12 months after the intervention
Change from baseline smoking quit rate at 12-month
Quit smoking rate is defined by the self-reported 7-day point prevalence abstinence. It is a binary type (yes/no) questionnaire and participants answer the question about their smoking status in the past 7 days at 12-month after the intervention.
Measured: 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 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
- Sponsor
- Investigators
- Man-ping Wang, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659774
- Sponsor's protocol ID
- LSTWPLACE2015
- Status last verified
- Nov 2016
- First submitted
- 9 Jul 2015
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. 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
- NCT02659774
- Acronym / sponsor ID
- LSTWPLACE2015
- Conditions
- Smoking
- Keywords
- Smoking cessation interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Lok Sin Tong Benevolent Society, Kowloon
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- 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.
This study has the following objectives:
- To examine the employers'/managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace.
- To evaluate the smoking behaviours of participants before and after attending a smoking cessation intervention.
Detailed description
Study design In Phase I of this study, a large scale cross-sectional survey will be sent to 3000 corporations in Hong Kong. The questionnaire will examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplace.
In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a smoking cessation intervention offered by the Department of Psychology, the University of Hong Kong. A total of 600 smokers from corporations will be recruited and interviewed before the intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and 52-week post-intervention follow-ups, in an attempt to evaluate their smoking behaviours, knowledge on smoking and satisfaction of the smoking cessation services. Self-reported quitters (did not smoke in the past 7 days) will be invited to participate in the bio-chemical validation by assessing their exhaled carbon monoxide level and the saliva cotinine level.
Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group will be conducted within 1 month after 12-month follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: workshop (Motivational intervention), Behavioral: Health talk, Behavioral: SMS, Behavioral: BookletHealth talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS) |
| Group B | Placebo comparator | Behavioral: Health talk, Behavioral: Face to Face counseling, Behavioral: SMS, Behavioral: BookletFace to Face counseling (Motivational intervention) + Booklet + SMS |
| Group C | Placebo comparator | Behavioral: Health talk, Behavioral: SMS, Behavioral: BookletPhone counseling (Motivational intervention) + Health talk + booklet + SMS |
| Group D | Placebo comparator | Behavioral: Phone counseling, Behavioral: SMS, Behavioral: BookletPhone counseling (Motivational intervention) + booklet + SMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hong Kong residents aged 18 or above
- Cantonese speaker and able to read in Chinese characters
- Smoke at least one cigarette per day
- Stay at Hong Kong during the intervention and follow-up periods (12 months)
Key exclusion criteria (3 listed)
- Smokers who are psychologically or physically unable to communicate
- Smokers who are currently following other smoking cessation programme(s)
- Smokers with diagnosed psychiatric illnesses
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 |
|---|---|---|
| workshop (Motivational intervention)Through intensive workshop which includes motivation of quitting enhancement, stress management, smoking triggers, cravings and relapse, to provide smoking cessation intervention | Behavioural | Group A |
| 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 | Group A, Group B, Group C |
| Face to Face counselingUse motivational interview strategies through face-to-face counseling to provide smoking cessation intervention | Behavioural | Group B |
| Phone counselingUse motivational interview strategies through telephone counseling to provide smoking cessation intervention | Behavioural | Group D |
| SMSUse motivational interview strategies through telephone messages to provide smoking cessation intervention | Behavioural | Group A, Group B, Group C, Group D |
| BookletA 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting | Behavioural | Group A, Group B, Group C, Group D |
Primary outcome
Change from baseline smoking quit rate at 6-month
Time frame: 6 months after the intervention
Quit smoking rate is defined by the self-reported 7-day point prevalence abstinence. It is a binary type (yes/no) questionnaire and participants answer the question about their smoking status in the past 7 days at 6-month after the intervention.
3 secondary outcomes
Change from baseline smoking reduction at 6-month
Time frame: 6 months after the intervention
Change from baseline smoking reduction at 12-month
Time frame: 12 months after the intervention
Change from baseline smoking quit rate at 12-month
Time frame: 12 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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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
School of Nursing, 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 workshop (Motivational intervention), Health talk and Face to Face counseling in people with Smoking, run by The University of Hong Kong at 1 site in China.
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 4 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 3 Nov 2016. 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 China. 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?
Change from baseline smoking quit rate at 6-month (time frame: 6 months after the intervention). 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 3 Nov 2016.