Smoking CessationNCT02758028
Helping Youth Smokers Stop Smoking Through the Youth Quitline Programme
A study testing Brief counseling in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.
Trial summary
The aims of the present study are: 1. To raise the awareness of smoking cessation service among youth smokers in Hong Kong; 2. To provide smoking cessation quitline service to youth smokers; and 3. To provide training to teenagers as peer smoking cessation counsellors. 4. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Brief counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2005to Nov 2021
- 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hong Kong resident aged 25 or below
- Able to communicate in Chinese (Cantonese)
- Smoked in the past 30 days
Who cannot join
- Have difficulty to communicate via telephone
- Having queries irrelevant to tobacco control
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
William Li, PhD, 852-39176634, william3@hku.hk
Ho Cheung William Li, PhD
About this study
The aims of the present study are:
- To raise the awareness of smoking cessation service among youth smokers in Hong Kong;
- To provide smoking cessation quitline service to youth smokers; and
- To provide training to teenagers as peer smoking cessation counsellors.
- To examine the effectiveness of adventure-based training and WhatsApp messages in helping youth smokers to quit
Read the detailed description
In Hong Kong, the demand of smoking cessation service of Youth was increasing in the past 10 years, the first youth-oriented smoking cessation hotline "Youth Quitline" was established in 2005. From August 2005 to July 2016, "Youth Quitline" has received over 9,267 telephone inquiries and provided telephone smoking cessation counselling for 1,952 youth smokers.
Youth smokers are recruited using the reactive and proactive strategies. The operation hours of Quitline service are weekdays from 17:00 to 21:00 and on weekends from 14:00 to 20:00. A questionnaire asking the smoking status, reason of smoking, dependency level, knowledge, attitude and practice of smoking or quitting at baseline, the perceived barriers of the smokers and the use of other tobacco products were designed to assess the status of participants, brief counselling with the use of motivational intervention approach is delivered during the phone call.
Telephone counseling at 1-week, 1-month, 3-month, 6-month, 9-month, 12-month and follow-up at 24-month are conducted with the participants to assess their smoking status (by questionnaire) and reinforce intervention (encourage quitting and providing quitting tips). Self-reported quitters who have quitted smoking for at least 7 days at 6-month are invited to perform saliva cotinine test (using NicAlert strip) plus exhaled carbon monoxide text to validate the smoking status.
A qualitative interview will be conducted to investigate the use of other tobacco products of the Youth Quitline participants, and aimed to find out their smoking patterns and feelings of using these products, and how these products might affect quitting or smoking, and how the protest activates influence the smoking behaviors among the youth smokers.
- Conditions
- Smoking Cessation
- Being tested
- Brief counseling
- Keywords
- Youth, Adventure-based training, WhatsApp messages
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief counselingBehavioural
Peer counselling is delivered based on the queries and the needs of individual clients, according to the smoking status, dependency level and the perceived barriers of each individual with the use of motivational intervention approach.
The subjects will be followed up at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month via telephone assessing their smoking status and reinforce intervention.
| Study group | Role | What they receive |
|---|---|---|
| Brief counseling | Other | Peer counselling is delivered based on the queries and the needs of individual clients, according to the smoking status, dependency level and the perceived barriers of each individual with the use of motivational intervention approach. Counsellors will emphasizes the identification, use, and modification of personally relevant coping strategies. Advice will be provided on overcoming expected difficulty, withdrawal symptoms and relapse prevention during quitting.
The subjects will be followed up at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month via telephone assessing their smoking status and reinforce intervention. Receives: Behavioral: Brief counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-days point prevalence smoking abstinence at 6-month
7-days point prevalence smoking abstinence is measured at 6-month. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self-reported smoking abstinence at 6-month.
Measured: 6-month follow-up
Secondary outcomes (1)
Bio-chemical validated smoking abstinence at 6-month
Bio-chemical validated smoking abstinence is measured at 6-month. The participants who claim to have quitted smoking for at least 7 days are invited for biochemical validation (measurement of saliva cotinine level and exhaled carbon monoxide level) at 6-month. The participants are need to get the results of CO≤ 4ppm, and continine level ≤30 ng/ml as passing results.
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 posted2 May 2016 (estimated)
- Study startAug 2005
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- Ho-Cheung Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758028
- Sponsor's protocol ID
- YouthQuitline
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2016
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Youth Smokers Stop Smoking Through the Youth Quitline Programme
- ClinicalTrials.gov ID
- NCT02758028
- Acronym / sponsor ID
- YouthQuitline
- Conditions
- Smoking Cessation
- Keywords
- Youth, Adventure-based training, WhatsApp messages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 2 May 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.
The aims of the present study are:
- To raise the awareness of smoking cessation service among youth smokers in Hong Kong;
- To provide smoking cessation quitline service to youth smokers; and
- To provide training to teenagers as peer smoking cessation counsellors.
- To examine the effectiveness of adventure-based training and WhatsApp messages in helping youth smokers to quit
Detailed description
In Hong Kong, the demand of smoking cessation service of Youth was increasing in the past 10 years, the first youth-oriented smoking cessation hotline "Youth Quitline" was established in 2005. From August 2005 to July 2016, "Youth Quitline" has received over 9,267 telephone inquiries and provided telephone smoking cessation counselling for 1,952 youth smokers.
Youth smokers are recruited using the reactive and proactive strategies. The operation hours of Quitline service are weekdays from 17:00 to 21:00 and on weekends from 14:00 to 20:00. A questionnaire asking the smoking status, reason of smoking, dependency level, knowledge, attitude and practice of smoking or quitting at baseline, the perceived barriers of the smokers and the use of other tobacco products were designed to assess the status of participants, brief counselling with the use of motivational intervention approach is delivered during the phone call.
Telephone counseling at 1-week, 1-month, 3-month, 6-month, 9-month, 12-month and follow-up at 24-month are conducted with the participants to assess their smoking status (by questionnaire) and reinforce intervention (encourage quitting and providing quitting tips). Self-reported quitters who have quitted smoking for at least 7 days at 6-month are invited to perform saliva cotinine test (using NicAlert strip) plus exhaled carbon monoxide text to validate the smoking status.
A qualitative interview will be conducted to investigate the use of other tobacco products of the Youth Quitline participants, and aimed to find out their smoking patterns and feelings of using these products, and how these products might affect quitting or smoking, and how the protest activates influence the smoking behaviors among the youth smokers.
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 |
|---|---|---|
| Brief counseling | Other | Behavioral: Brief counselingPeer counselling is delivered based on the queries and the needs of individual clients, according to the smoking status, dependency level and the perceived barriers of each individual with the use of motivational intervention approach. Counsellors will emphasizes the identification, use, and modification of personally relevant coping strategies. Advice will be provided on overcoming expected difficulty, withdrawal symptoms and relapse prevention during quitting. The subjects will be followed up at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month via telephone assessing their smoking status and reinforce intervention. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Hong Kong resident aged 25 or below
- Able to communicate in Chinese (Cantonese)
- Smoked in the past 30 days
Key exclusion criteria (2 listed)
- Have difficulty to communicate via telephone
- Having queries irrelevant to tobacco control
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 |
|---|---|---|
| Brief counselingPeer counselling is delivered based on the queries and the needs of individual clients, according to the smoking status, dependency level and the perceived barriers of each individual with the use of motivational intervention approach. The subjects will be followed up at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month via telephone assessing their smoking status and reinforce intervention. | Behavioural | Brief counseling |
Primary outcome
7-days point prevalence smoking abstinence at 6-month
Time frame: 6-month follow-up
7-days point prevalence smoking abstinence is measured at 6-month. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self-reported smoking abstinence at 6-month.
1 secondary outcome
Bio-chemical validated smoking abstinence at 6-month
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 14 Dec 2020.
- Individual participant dataSharing planned: Yes. The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
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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.
Ho-Cheung Li, 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 Brief counseling in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 14 Dec 2020. 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 China. 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?
Contact Ho-Cheung Li, PhD (39176634, william3@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-days point prevalence smoking abstinence at 6-month (time frame: 6-month follow-up). 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 14 Dec 2020.