SmokingNCT02949648
Electronic Cigarette Use and Quitting in Youth
An observational study of Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong Kong. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Smoking
- What is being tested?
- Electronic cigarette
- Type of treatment
- Medical device
- How many people
- 189 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2015to Aug 2016
- Phase
- Observational
- 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Youth in Hong Kong
Who may be able to join
- Ethnic Chinese
- Cantonese speakers
- Smoke at least 1 cigarette in the past 30 days
Who cannot join
- Psychologically or physically unable to communicate
- Undergoing other smoking cessation programme
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Youth Quitline, School of Nursing, The University of Hong Kong
Hong Kong
About this study
Official title: A Pilot Study on Electronic Cigarette Use and Their Impact on Smoking and Quitting in Youth
A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong Kong.
Read the detailed description
Subjects are from a cohort of Youth Quitline callers and smoking youth (N=200) in Hong Kong. The longitudinal study will investigate the effects of baseline e-cigarette use on quitting (including relapse), nicotine addiction and intention to smoke at 12-month telephone follow-up. A qualitative study will be conducted on 10 ex- and 10 current smokers to supplement and facilitate interpretation of the quantitative findings.
- Conditions
- Smoking
- Being tested
- Electronic cigarette
- Keywords
- Electronic cigarette
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic cigaretteDevice
Also called Electronic nicotine delivery system
Electronic cigarettes are devices that do not burn or use tobacco leaves but instead vaporize a solution the user then inhales. The device contains an electronic vaporization system, rechargeable batteries, electronic controls and cartridges of the liquid is vaporized.
| Study group | Role | What they receive |
|---|---|---|
| Electronic cigarette ever user | Youth Quitline callers who reported ever use of e-cigarette at baseline. Receives: Device: Electronic cigarette | |
| Electronic cigarette never user | Youth Quitline callers who reported never use of e-cigarette at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence assessed in the telephone follow-up survey
Self-reported 7-day point prevalence abstinence (PPA) is a validated, commonly used measure of smoking cessation. Subjects who reports no smoking in the preceding 7 days at the time of 12-month survey in the follow-up are regarded as quitters.
This measure has serval advantages compared to continuous abstinence. First, it can include smokers who take delayed action and quit. It also allows relapses to occur in the follow up period, without classifying smokers as permanent failure. Third, it does not rely on recall of past events happened long ago.
Measured: 12 months after baseline survey
Secondary outcomes (2)
Quit attempts assessed in the telephone follow-up survey
Smokers report how many times they try to abstain from cigarette for more than 24 hours in the whole follow-up period
Measured: 12 months after baseline survey
Intention to quit assessed in the telephone follow-up survey
Smokers report whether they intend to quit smoking at the time of 12-month survey in the follow-up
Measured: 12 months after baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
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, mpwang@hku.hk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949648
- Sponsor's protocol ID
- EC use and quitting in youth
- Status last verified
- Oct 2016
- First submitted
- 19 May 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Electronic Cigarette Use and Their Impact on Smoking and Quitting in Youth
- ClinicalTrials.gov ID
- NCT02949648
- Acronym / sponsor ID
- EC use and quitting in youth
- Conditions
- Smoking
- Keywords
- Electronic cigarette
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong Kong.
Detailed description
Subjects are from a cohort of Youth Quitline callers and smoking youth (N=200) in Hong Kong. The longitudinal study will investigate the effects of baseline e-cigarette use on quitting (including relapse), nicotine addiction and intention to smoke at 12-month telephone follow-up. A qualitative study will be conducted on 10 ex- and 10 current smokers to supplement and facilitate interpretation of the quantitative findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic cigarette ever user | – | Device: Electronic cigaretteYouth Quitline callers who reported ever use of e-cigarette at baseline. |
| Electronic cigarette never user | – | –Youth Quitline callers who reported never use of e-cigarette at baseline. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth in Hong Kong
Key inclusion criteria (3 listed)
- Ethnic Chinese
- Cantonese speakers
- Smoke at least 1 cigarette in the past 30 days
Key exclusion criteria (2 listed)
- Psychologically or physically unable to communicate
- Undergoing other smoking cessation programme
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 |
|---|---|---|
| Electronic cigaretteAlso: Electronic nicotine delivery systemElectronic cigarettes are devices that do not burn or use tobacco leaves but instead vaporize a solution the user then inhales. The device contains an electronic vaporization system, rechargeable batteries, electronic controls and cartridges of the liquid is vaporized. | Device | Electronic cigarette ever user |
Primary outcome
7-day point prevalence abstinence assessed in the telephone follow-up survey
Time frame: 12 months after baseline survey
Self-reported 7-day point prevalence abstinence (PPA) is a validated, commonly used measure of smoking cessation. Subjects who reports no smoking in the preceding 7 days at the time of 12-month survey in the follow-up are regarded as quitters. This measure has serval advantages compared to continuous abstinence. First, it can include smokers who take delayed action and quit. It also allows relapses to occur in the follow up period, without classifying smokers as permanent failure. Third, it does not rely on recall of past events happened long ago.
2 secondary outcomes
Quit attempts assessed in the telephone follow-up survey
Time frame: 12 months after baseline survey
Intention to quit assessed in the telephone follow-up survey
Time frame: 12 months after baseline survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: No
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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
mpwang@hku.hk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, 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 3 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: finished, as of the sponsor's last update on 31 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
7-day point prevalence abstinence assessed in the telephone follow-up survey (time frame: 12 months after baseline survey). 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 31 Oct 2016.