SmokersNCT05758272
Evaluation of a Workplace Smoking Cessation Program in Hong Kong (Phase VI)
A study testing mobile phone-based simple physical exercise reminder to help quit smoking and regular text-based intervention in people with Smokers and Workplace, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- mobile phone-based simple physical exercise reminder to help quit smoking and regular text-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 646 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 30 Dec 2024
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- mobile phone-based simple physical exercise reminder to help quit smoking, regular text-based intervention
- Keywords
- smokers, Workplace, Exercise, mhealth, intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile phone-based simple physical exercise reminder to help quit smokingBehavioural
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.
regular text-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mobile phone-based simple physical exercise intervention | Experimental | 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. Receives: Behavioral: mobile phone-based simple physical exercise reminder to help quit smoking |
| regular text-based intervention | Placebo comparator | 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. Receives: Behavioral: regular text-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 7-day point-prevalence abstinence (PPA) at 6-months follow-up
Self-reported abstinence in the past 7 days at 6-months after treatment initiation
Measured: at 6-month after treatment initiation (3 months after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 646 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping WANG, PhD, Principal investigator, School of Nursing, The University of Hong Kong Hong Kong, Hong Kong China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758272
- Sponsor's protocol ID
- SCPW Phase 6
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05758272
- Acronym / sponsor ID
- SCPW Phase 6
- Keywords
- smokers, Workplace, Exercise, mhealth, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 646 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Mar 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile phone-based simple physical exercise intervention | Experimental | Behavioral: mobile phone-based simple physical exercise reminder to help quit smokingRegular 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 text-based intervention | Placebo comparator | Behavioral: regular text-based interventionThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- 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 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| mobile phone-based simple physical exercise reminder to help quit smokingRegular 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. | Behavioural | mobile phone-based simple physical exercise intervention |
| regular text-based interventionThe 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. | Behavioural | regular text-based intervention |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No. 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.
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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 Hong Kong, Hong Kong China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile phone-based simple physical exercise reminder to help quit smoking and regular text-based intervention in people with Smokers and Workplace, 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 4 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 13 Dec 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?
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?
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)). 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 13 Dec 2023.