- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03870906
Smoking Cessation Programme in Workplaces in Hong Kong (Phase IV)
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 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 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
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Smokers who are psychologically or physically unable to communicate
- Currently following other smoking cessation programme(s)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: WhatsApp interaction
Individual and group chat interactions.
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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.
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.
The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
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|
Placebo Comparator: Text message
Regular text messages with similar frequency to those in the Intervention group.
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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.
The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
Participants will receive regular text messages with similar frequency to those in the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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6-month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported 7-day point prevalence quit rate
Time Frame: 9- and 12-month
|
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
|
9- and 12-month
|
|
Self-reported reduction rate
Time Frame: 6-, 9-, and 12-month
|
Smokers' who reduced tobacco use (in term of daily cigarette consumption) in the follow-up when comparing with the baseline
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6-, 9-, and 12-month
|
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Biochemical validation of smoking status
Time Frame: 6-, 9-, and 12-month
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Biochemically validated quit rate (saliva cotinine level and exhale carbon monoxide test)
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6-, 9-, and 12-month
|
Collaborators and Investigators
Sponsor
Collaborators
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 P4
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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