- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05758272
Evaluation of a Workplace Smoking Cessation Program in Hong Kong (Phase VI)
December 6, 2023 updated by: Dr. Wang Man-Ping, The University of Hong Kong
Evaluation of a Workplace Smoking Cessation Program in Hong Kong: a Pragmatic Cluster Randomized Controlled Trial of Mobile Supported Simple Physical Exercise for Smoking Cessation
This study aims to test, by a 2-arm RCT, the effectiveness of an intervention that includes mobile phone-supported simple physical exercise for smoking cessation in workplaces in Hong Kong.
Study Overview
Status
Active, not recruiting
Study Type
Interventional
Enrollment (Estimated)
646
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- School of Nursing, The University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Smoke at least 1 cigarette per day or use other tobacco products (EC, HTP and others) daily
- Able to communicate in Cantonese/Mandarin and read Chinese
- Able to use instant messaging tools (e.g. WhatsApp) for communication
- 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 joining other smoking cessation program(s)
- Smokers who cannot tolerate the proposed exercise program
- Smokers who have severe mental illnesses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: regular text-based intervention
The control group will receive 6 regular messages via IM at twice per month within 3 months.
These messages cover simple cessation advice and reminders for telephone follow-ups.
|
The control group will receive 6 regular messages via IM at twice per month within 3 months.
These messages cover simple cessation advice and reminders for telephone follow-ups.
|
Experimental: mobile phone-based simple physical exercise intervention
Regular messages supporting participants in practicing simple physical exercises and assist in managing cravings will be sent to participants via IM apps and scheduled in a tapering manner for 3 months (twice per week in the first month to once per week in the third month).
Images and videos explaining and demonstrating the simple physical exercises will be sent to the participants via IM apps, which serves as a reminder and supporting materials for participants.
The benefits of exercise in SC will be explained.
The investigators will also encourage the practice of moderate/ vigorous exercises to further improve the physical activity and well-being of the participants.
Various delivery formats of messages will be considered to attract participants' interest such as text, emojis, voice, image, animation, and video.
The simple exercises consist of a) Zero-time exercises (ZTEx), b) handgrip exercises and c) resistance exercises.
|
Regular messages supporting participants in practicing simple physical exercises and assist in managing cravings will be sent to participants via IM apps and scheduled in a tapering manner for 3 months (twice per week in the first month to once per week in the third month).
Images and videos explaining and demonstrating the simple physical exercises will be sent to the participants via IM apps, which serves as a reminder and supporting materials for participants.
The benefits of exercise in SC will be explained.
The investigator will also encourage the practice of moderate/ vigorous exercises to further improve the physical activity and well-being of the participants.
Various delivery formats of messages will be considered to attract participants' interest such as text, emojis, voice, image, animation, and video.
The simple exercises consist of a) Zero-time exercises (ZTEx), b) handgrip exercises and c) resistance exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported 7-day point-prevalence abstinence (PPA) at 6-months follow-up
Time Frame: at 6-month after treatment initiation (3 months after the end of treatment)
|
Self-reported abstinence in the past 7 days at 6-months after treatment initiation
|
at 6-month after treatment initiation (3 months after the end of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Man Ping WANG, PhD, School of Nursing, The University of Hong Kong Hong Kong, Hong Kong China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
February 23, 2023
First Submitted That Met QC Criteria
February 24, 2023
First Posted (Actual)
March 7, 2023
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SCPW Phase 6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participant data (IPD) will only be used for data analysis by the investigators, kept strictly confidential, and not disclosed to anyone outside the research group.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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