Smoking CessationNCT04088539
Promoting Smoking Cessation in the Correctional Institutions
A study testing AWARD advice and Video-based health education in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- AWARD advice and Video-based health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Sep 2019to 30 Dec 2022
- 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
- Smoke at least 1 cigarette per day in the past 3 months
- Able to communicate in Cantonese (including reading Chinese)
- Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
- Intent to quit / reduce smoking
Who cannot join
- Smokers who have difficulties (either physical or cognitive condition) to communicate
- Currently following other smoking cessation programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Capacity and Promoting Smoking Cessation in the Correctional Institutions
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:
- To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
- To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
- To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.
Read the detailed description
Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking [5] which accounts for over 7,000 deaths per year. Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. Despite the low smoking rate in the general population, smoking prevalence remain high in the correctional institutions. Incarcerated prisoners suffer disproportionately from mental illness, substance use disorders and disease infections. They are in need of health care such as treatment or prevention for smoking. There is a lack of evidence on the effectiveness of smoking cessation intervention in the correctional setting. More work is required to provide smoking cessation assistance to these high risk and underserved population.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:
- To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
- To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
- To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.
- Conditions
- Smoking Cessation
- Being tested
- AWARD advice, Video-based health education
- Keywords
- Smoking cessation, Brief intervention, Correctional institution
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARD adviceBehavioural
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date)
Video-based health educationBehavioural
Educational videos on smoking and health will be developed to improve the knowledge of CSD smokers. The videos aim to raise their awareness on these important health topics and acquire effective cessation methods. The effectiveness of the educational videos will be evaluated by pre- and post-tests through a self-administered survey that assess the changes in knowledge related to smoking hazards, benefits of quitting, and methods to quit smoking.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | CSD participants will receive a combined intervention:
1. Brief intervention using AWARD advice at baseline,
2. Video-based health education Receives: Behavioral: AWARD advice; Behavioral: Video-based health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical validated quit rate at 6-month follow-up
The primary outcome is biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) at 6-month
Measured: 6-month follow-up
Biochemical validated quit rate at 3-month follow-up
The primary outcome is biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) at 3-month
Measured: 3-month follow-up
Secondary outcomes (4)
Smoking quit rate change from baseline at 3-month follow-up
Self-reported 7-day point prevalence (pp) quit rate at 3-month
Measured: 3-month follow-up
Smoking quit rate change from baseline at 6-month follow-up
Self-reported 7-day point prevalence (pp) quit rate at 6-month
Measured: 6-month follow-up
Smoking reduction rate change from baseline at 3-month follow-up
Rate of smoking reduction by at least half of baseline amount
Measured: 3-month follow-up
Smoking reduction rate change from baseline at 6-month follow-up
Rate of smoking reduction by at least half of baseline amount
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start12 Sep 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088539
- Sponsor's protocol ID
- CSD 2019-2021
- Status last verified
- Nov 2021
- First submitted
- 11 Sep 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity and Promoting Smoking Cessation in the Correctional Institutions
- ClinicalTrials.gov ID
- NCT04088539
- Acronym / sponsor ID
- CSD 2019-2021
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Brief intervention, Correctional institution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Sep 2019 (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.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:
- To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
- To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
- To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.
Detailed description
Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking [5] which accounts for over 7,000 deaths per year. Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. Despite the low smoking rate in the general population, smoking prevalence remain high in the correctional institutions. Incarcerated prisoners suffer disproportionately from mental illness, substance use disorders and disease infections. They are in need of health care such as treatment or prevention for smoking. There is a lack of evidence on the effectiveness of smoking cessation intervention in the correctional setting. More work is required to provide smoking cessation assistance to these high risk and underserved population.
The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:
- To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
- To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
- To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: AWARD advice, Behavioral: Video-based health educationCSD participants will receive a combined intervention: 1. Brief intervention using AWARD advice at baseline, 2. Video-based health education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 in the past 3 months
- Able to communicate in Cantonese (including reading Chinese)
- Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
- Intent to quit / reduce smoking
Key exclusion criteria (2 listed)
- Smokers who have difficulties (either physical or cognitive condition) to communicate
- Currently following other smoking cessation programs
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 |
|---|---|---|
| AWARD adviceAsk about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date) | Behavioural | Group A |
| Video-based health educationEducational videos on smoking and health will be developed to improve the knowledge of CSD smokers. The videos aim to raise their awareness on these important health topics and acquire effective cessation methods. The effectiveness of the educational videos will be evaluated by pre- and post-tests through a self-administered survey that assess the changes in knowledge related to smoking hazards, benefits of quitting, and methods to quit smoking. | Behavioural | Group A |
Primary outcome
Biochemical validated quit rate at 6-month follow-up
Time frame: 6-month follow-up
The primary outcome is biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) at 6-month
Biochemical validated quit rate at 3-month follow-up
Time frame: 3-month follow-up
The primary outcome is biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) at 3-month
4 secondary outcomes
Smoking quit rate change from baseline at 3-month follow-up
Time frame: 3-month follow-up
Smoking quit rate change from baseline at 6-month follow-up
Time frame: 6-month follow-up
Smoking reduction rate change from baseline at 3-month follow-up
Time frame: 3-month follow-up
Smoking reduction rate change from baseline at 6-month follow-up
Time frame: 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Using Smartwatches to Monitor Smoking in Real-life Situations
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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
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Smoking Cessation
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
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 AWARD advice and Video-based health education in people with Smoking Cessation, 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 2 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 1 Dec 2021. 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. 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?
Biochemical validated quit rate at 6-month follow-up (time frame: 6-month follow-up). The study lists 2 primary outcomes in all. 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 1 Dec 2021.