Smoking CessationNCT04599049
Evaluation Study on Smoke-free Teens Programme 2020-2021
A study testing six sessions of online classes and virtual training day camps through Zoom in two days in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objectives are: i. To evaluate Smoke-free Teens' change in knowledge on smoking hazards, attitudes towards smoking, tobacco control and smoking cessation, and practices for promoting smoking prevention and cessation, ii. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- six sessions of online classes and virtual training day camps through Zoom in two days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Oct 2020to 31 Jul 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The objectives are:
- To evaluate Smoke-free Teens' change in knowledge on smoking hazards, attitudes towards smoking, tobacco control and smoking cessation, and practices for promoting smoking prevention and cessation, ii. To evaluate the process and quality of smoke-free programmes organized by the Smoke-free Teens in their schools/community, and iii. To measure the number of people reached in the smoke-free programmes organized by the Smoke-free Teens.
Read the detailed description
Participants Youth between Form 1 and 4 or aged 14 to 18 in the school academic year 2019-2020 will be nominated by secondary schools, youth centres and uniform groups to participate in the Smoke-free Teens Programme 2020-2021.
Outcomes The primary outcomes include the change in (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) the Smoke-free Teens' satisfaction on the training camp.
The secondary outcomes are (1) the number of people participated in the school- or community-based smoke-free programmes organised by the Smoke-free Teens, and (2) the number of smokers advised and referred to existing smoking cessation services by the Smoke-free Teens.
Smoke-free Teens Programme The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by Hong Kong Council on Smoking and Health (COSH). The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation.In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model: 1) Ask about smoking, 2) Warn the smokers that at least half will be killed by smoking, 3) Advise to quit (reduce) as soon as possible, 4) Refer to cessation clinics or hotlines, and 5) Do it again until the smokers quit. By the end of the training camp, the teens should be confident and competent in delivering the brief smoking cessation intervention to smokers. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
Survey instrument A structured questionnaire designed by the smoking cessation team, School of Nursing, the University of Hong Kong will be used to evaluate the training camp. The questionnaire covers four areas, including (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) self-efficacy to deliver smoking cessation advices. The items of the questionnaire have been adopted and modified from previous studies on smoking cessation, with well-established psychometric properties. A process evaluation form (Appendix 4) will also be developed by the smoking cessation team to assess how the teens satisfy with the online classes and training camp, and to determine whether the content of online classes and training camp meets the learning needs and expectations of the teens. Table 1 shows the items that will be asked at each time point.
To evaluate the smoke-free programmes organized after the training camp, each group of the Smoke-free Teens will be required to submit a written proposal to COSH. In addition, a final report that contains the information about the number of people reached by the programmes, publicity, and the process and outcomes of the programmes, will be submitted for review.
Data collection Data collection will be conducted by COSH. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). In addition, they will be asked to complete a process evaluation form immediately after the training camp (T3). Comments and suggestions provided by the teens in the process evaluation form will be taken into account for future improvement of the training camp. In addition, each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively.
Statistical analysis The Statistical Package for Social Science (SPSS: Version 23; SPSS Inc., Chicago, IL, USA) for Windows will be employed to analyze the data. Descriptive statistics will be used to describe the demographic characteristics of the Smoke-free Teens. Paired samples t-test and Wilcoxon signed-rank test will be conducted to assess the change in knowledge, attitudes and practices of the Smoke-free Teens regarding smoking, tobacco control and smoking cessation before and after the training camp. To evaluate the smoke-free programmes organized by the Smoke-free Teens after the training camp, descriptive statistics will be used to report the number of people reached by the programmes, publicity, and the process and outcomes of the programmes.
- Conditions
- Smoking Cessation
- Being tested
- six sessions of online classes and virtual training day camps through Zoom in two days
- Keywords
- Smoke-free, Teens
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
six sessions of online classes and virtual training day camps through Zoom in two daysOther
The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively.
| Study group | Role | What they receive |
|---|---|---|
| six sessions of online classes and virtual training day camps through Zoom in two days | Other | The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. Receives: Other: six sessions of online classes and virtual training day camps through Zoom in two days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge on smoking hazards at baseline level
Smoke-free Teens' knowledge on smoking hazards at baseline level will be measured by the scale called "knowledge on smoking hazards" in a self-reporting structured questionnaire.
Measured: Baseline
The change in knowledge on smoking hazards
The change in Smoke-free Teens' knowledge on smoking hazards immediately after the online classes and 3 months will be measured by the scale called "knowledge on smoking hazards" in a self-reporting structured questionnaire.
Measured: Baseline, immediately after the online classes and 3 months
Attitudes towards smoking, tobacco control and smoking cessation at baseline level
Smoke-free Teens' attitudes towards smoking, tobacco control and smoking cessation at baseline level will be measured by the scale called "attitudes towards smoking, tobacco control and smoking cessation" in a self-reporting structured questionnaire.
Measured: Baseline
The change in attitudes towards smoking, tobacco control and smoking cessation
The change in Smoke-free Teens' attitudes towards smoking, tobacco control and smoking cessation immediately after the online classes and 3 months will be measured by the scale called "attitudes towards smoking, tobacco control and smoking cessation" in a self-reporting structured questionnaire.
Measured: Baseline, immediately after the online classes and 3 months
Practices for promoting smoking prevention and cessation at baseline level
Smoke-free Teens' practices for promoting smoking prevention and cessation at baseline level will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire
Measured: Baseline
The change in practices for promoting smoking prevention and cessation
The change in Smoke-free Teens' practices for promoting smoking prevention and cessation after 3 months will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire.
Measured: Baseline and 3 months
Self-efficacy to deliver smoking cessation advices at baseline level
Smoke-free Teens' self-efficacy to deliver smoking cessation advices at baseline level will be measured by the scale called "self-efficacy to deliver smoking cessation advices" in a self-reporting structured questionnaire.
Measured: Baseline
The change in self-efficacy to deliver smoking cessation advices
The change in Smoke-free Teens' self-efficacy to deliver smoking cessation advices immediately after the training camp, after after the online classes and 3 months will be measured by the scale called "self-efficacy to deliver smoking cessation advices" in a self-reporting structured questionnaire.
Measured: Baseline, immediately after the online classes and 3 months
Process evaluation of the training camp
Smoke-free Teens' feedback and views of the training camp will be measured immediately after the training camp by the scale called "process evaluation" in a self-reporting structured questionnaire.
Measured: immediately after the training camp
Secondary outcomes (2)
The number of people participated in the school- or community-based smoke-free programmes organized by the Smoke-free Teens after the training camp
After the online classes, the teens will be required to organize smoke-free programmes in their schools or communities so as to deliver brief smoking cessation intervention and to promote smoke-free messages in their schools and communities. The number of people participated in these school- or community-based smoke-free programmes will be measured by a final report submitted by the teens that indicate the relevant information.
Measured: 3 months
The number of smokers advised and referred to existing smoking cessation
After the online classes, the teens will organize smoke-free programmes in their schools or in the communities so as to deliver brief smoking cessation intervention and to promote smoke-free messages in their schools and communities. The number of smokers the teens advised and referred to existing smoking cessation services during these school- or community-based smoke-free programmes will be measured by a final report submitted by the teens that indicate the relevant information.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start30 Oct 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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
- 173 participants (actual)
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
- William LI, PhD, Principal investigator, School of Nursing, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599049
- Sponsor's protocol ID
- Smoke-free Teens 2020
- Status last verified
- Dec 2020
- First submitted
- 16 Oct 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study on Smoke-free Teens Programme 2020-2021
- ClinicalTrials.gov ID
- NCT04599049
- Acronym / sponsor ID
- Smoke-free Teens 2020
- Conditions
- Smoking Cessation
- Keywords
- Smoke-free, Teens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Oct 2020 (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 objectives are:
- To evaluate Smoke-free Teens' change in knowledge on smoking hazards, attitudes towards smoking, tobacco control and smoking cessation, and practices for promoting smoking prevention and cessation, ii. To evaluate the process and quality of smoke-free programmes organized by the Smoke-free Teens in their schools/community, and iii. To measure the number of people reached in the smoke-free programmes organized by the Smoke-free Teens.
Detailed description
Participants Youth between Form 1 and 4 or aged 14 to 18 in the school academic year 2019-2020 will be nominated by secondary schools, youth centres and uniform groups to participate in the Smoke-free Teens Programme 2020-2021.
Outcomes The primary outcomes include the change in (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) the Smoke-free Teens' satisfaction on the training camp.
The secondary outcomes are (1) the number of people participated in the school- or community-based smoke-free programmes organised by the Smoke-free Teens, and (2) the number of smokers advised and referred to existing smoking cessation services by the Smoke-free Teens.
Smoke-free Teens Programme The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by Hong Kong Council on Smoking and Health (COSH). The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation.In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model: 1) Ask about smoking, 2) Warn the smokers that at least half will be killed by smoking, 3) Advise to quit (reduce) as soon as possible, 4) Refer to cessation clinics or hotlines, and 5) Do it again until the smokers quit. By the end of the training camp, the teens should be confident and competent in delivering the brief smoking cessation intervention to smokers. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
Survey instrument A structured questionnaire designed by the smoking cessation team, School of Nursing, the University of Hong Kong will be used to evaluate the training camp. The questionnaire covers four areas, including (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) self-efficacy to deliver smoking cessation advices. The items of the questionnaire have been adopted and modified from previous studies on smoking cessation, with well-established psychometric properties. A process evaluation form (Appendix 4) will also be developed by the smoking cessation team to assess how the teens satisfy with the online classes and training camp, and to determine whether the content of online classes and training camp meets the learning needs and expectations of the teens. Table 1 shows the items that will be asked at each time point.
To evaluate the smoke-free programmes organized after the training camp, each group of the Smoke-free Teens will be required to submit a written proposal to COSH. In addition, a final report that contains the information about the number of people reached by the programmes, publicity, and the process and outcomes of the programmes, will be submitted for review.
Data collection Data collection will be conducted by COSH. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). In addition, they will be asked to complete a process evaluation form immediately after the training camp (T3). Comments and suggestions provided by the teens in the process evaluation form will be taken into account for future improvement of the training camp. In addition, each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively.
Statistical analysis The Statistical Package for Social Science (SPSS: Version 23; SPSS Inc., Chicago, IL, USA) for Windows will be employed to analyze the data. Descriptive statistics will be used to describe the demographic characteristics of the Smoke-free Teens. Paired samples t-test and Wilcoxon signed-rank test will be conducted to assess the change in knowledge, attitudes and practices of the Smoke-free Teens regarding smoking, tobacco control and smoking cessation before and after the training camp. To evaluate the smoke-free programmes organized by the Smoke-free Teens after the training camp, descriptive statistics will be used to report the number of people reached by the programmes, publicity, and the process and outcomes of the programmes.
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 |
|---|---|---|
| six sessions of online classes and virtual training day camps through Zoom in two days | Other | Other: six sessions of online classes and virtual training day camps through Zoom in two daysThe Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| six sessions of online classes and virtual training day camps through Zoom in two daysThe Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. | Other | six sessions of online classes and virtual training day camps through Zoom in two days |
Primary outcome
Knowledge on smoking hazards at baseline level
Time frame: Baseline
Smoke-free Teens' knowledge on smoking hazards at baseline level will be measured by the scale called "knowledge on smoking hazards" in a self-reporting structured questionnaire.
The change in knowledge on smoking hazards
Time frame: Baseline, immediately after the online classes and 3 months
The change in Smoke-free Teens' knowledge on smoking hazards immediately after the online classes and 3 months will be measured by the scale called "knowledge on smoking hazards" in a self-reporting structured questionnaire.
Attitudes towards smoking, tobacco control and smoking cessation at baseline level
Time frame: Baseline
Smoke-free Teens' attitudes towards smoking, tobacco control and smoking cessation at baseline level will be measured by the scale called "attitudes towards smoking, tobacco control and smoking cessation" in a self-reporting structured questionnaire.
The change in attitudes towards smoking, tobacco control and smoking cessation
Time frame: Baseline, immediately after the online classes and 3 months
The change in Smoke-free Teens' attitudes towards smoking, tobacco control and smoking cessation immediately after the online classes and 3 months will be measured by the scale called "attitudes towards smoking, tobacco control and smoking cessation" in a self-reporting structured questionnaire.
Practices for promoting smoking prevention and cessation at baseline level
Time frame: Baseline
Smoke-free Teens' practices for promoting smoking prevention and cessation at baseline level will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire
The change in practices for promoting smoking prevention and cessation
Time frame: Baseline and 3 months
The change in Smoke-free Teens' practices for promoting smoking prevention and cessation after 3 months will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire.
Self-efficacy to deliver smoking cessation advices at baseline level
Time frame: Baseline
Smoke-free Teens' self-efficacy to deliver smoking cessation advices at baseline level will be measured by the scale called "self-efficacy to deliver smoking cessation advices" in a self-reporting structured questionnaire.
The change in self-efficacy to deliver smoking cessation advices
Time frame: Baseline, immediately after the online classes and 3 months
The change in Smoke-free Teens' self-efficacy to deliver smoking cessation advices immediately after the training camp, after after the online classes and 3 months will be measured by the scale called "self-efficacy to deliver smoking cessation advices" in a self-reporting structured questionnaire.
Process evaluation of the training camp
Time frame: immediately after the training camp
Smoke-free Teens' feedback and views of the training camp will be measured immediately after the training camp by the scale called "process evaluation" in a self-reporting structured questionnaire.
2 secondary outcomes
The number of people participated in the school- or community-based smoke-free programmes organized by the Smoke-free Teens after the training camp
Time frame: 3 months
The number of smokers advised and referred to existing smoking cessation
Time frame: 3 months
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 25 Oct 2021.
- 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.
William LI, PhD principal investigator
School of Nursing, 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 six sessions of online classes and virtual training day camps through Zoom in two days 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 0 inclusion and 1 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 25 Oct 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?
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?
Knowledge on smoking hazards at baseline level (time frame: Baseline). The study lists 9 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 25 Oct 2021.