- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03142555
Smoking Cessation Programme in Workplaces in Hong Kong (Phase III)
Assessing the Corporate Environment in Promoting Tobacco Control and Evaluation of a Smoking Cessation Programme in Workplaces in Hong Kong
Study Overview
Status
Conditions
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 randomized controlled trial study to evaluate the effectiveness of a smoking cessation intervention to assess the subjects' smoking behaviors, knowledge on smoking and satisfaction of the smoking cessation services. The investigators are interested to know if the intervention package including health education,social media and telephone follow-up would trigger higher quit rate or other changes in smoking behaviors. The investigators will also monitor the smoking status of the subjects regularly through telephone follow-ups, understand the company's practices about smoke-free policy as well as evaluate the outcomes of the intervention.
The primary outcome of the study is to measure participated smokers' self-reported 7-day point prevalence quit rate at 26 weeks follow-ups. The secondary outcomes include participated smokers' (i) self-reported reduction rate at 52 weeks follow-ups; (ii) self-reported quit attempt at 26 and 52 weeks follow-ups; (iii) self-reported reduction rate at 26 and 52 weeks follow-ups; (iv) Engagement in social media intervention.
Data of the above outcomes will be collected through telephone interviews (follow-ups) by the investigators. Descriptive statistics will be used to measure the (1) basic info of the participants, 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. Logistic regression, linear regression and spearman correlation coefficient will be used to examine the relationships between corporates' policy in smoking cessation and the knowledge and attitudes of employers/ managerial staff. Chi square and t-test will also be used to compare the quit rates between groups and logistic regression will be used to predict quitting. Data will be entered and analyzed using IBM SPSS version 23.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- School of Nursing, The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Cantonese speaker
- Smoke at least one cigarette per day in the past 30 days
- Stay in Hong Kong during the intervention and follow-up periods (12 months)
Exclusion Criteria:
- Smokers who are psychologically or physically unable to communicate
- Currently following other smoking cessation programme(s)
- Smokers with diagnosed psychiatric illnesses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health talk plus intensive social media intervention
Subjects in this group will receive:
|
Subjects in this group will receive treatments including a general health education talk about smoking cessation.
Subjects will also get involved in the personalized what's app interaction (up to 2 months duration) to receive social support to quit smoking.
The intervention outcomes and subjects' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
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Placebo Comparator: Health talk plus less intensive social media intervention
Subjects in this group will receive:
|
Subjects in this group will receive treatments including a general health education talk about smoking cessation but without the information of active referral to other smoking cessation services.
Subjects will receive less intensive reminders via social media.
The intervention outcomes and subjects' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported 7-day point prevalence quit rate
Time Frame: 26 weeks
|
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported 7-day point prevalence quit rate
Time Frame: 52 weeks
|
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
|
52 weeks
|
Self-reported reduction rate
Time Frame: 26 and 52 weeks
|
Smokers' who reduced tobacco use (in term of daily cigarette consumption) in the follow-up when comparing with the baseline
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26 and 52 weeks
|
Self-reported quit attempt rate
Time Frame: 26 and 52 weeks
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Smokers' who refrained from smoking for 24 hours in the 7 days preceding the follow-up
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26 and 52 weeks
|
Engagement in social media intervention
Time Frame: 26 weeks
|
Self-reported engagement in social media intervention in the two groups
|
26 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Tai Hing Lam, MD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LST SCPW P3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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