E-Cig UseNCT05482581
The Impact of Policies Regarding E-cigarette on Adolescents and Young Adults' Cognition and Behavior for E-cigarette
An observational study of E-Cig Use, run by Sun Yat-sen University at 1 site in China.
Trial summary
Based on the Knowledge，Attitude，Belief and Practice model(KABP model), this study intends to use a mixed method to explore the influencing mechanism of youth and adolescents' cognition and behavior for e-cigarette before and after the promulgation of the new regulations on e-cigarette . Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use
- What is being tested?
- Questionnaires set
- How many people
- 453 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2022to 1 Feb 2024
- 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 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Using an online and offline multi-channel model, participants who meet the eligibility criteria are invited to join the study.
Who may be able to join
- 14-35 years old;
- Being able to read and write in Chinese.
Who cannot join
- Those who are unable to communicate due to serious mental or physical illnesses such as deafness, unclear consciousness due to mental illness, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XIAW
Guangzhou, Guangdong, 510080
Wei Xia, PhD, 18823359471, xiaw23@mail.sysu.edu.cn
About this study
Official title: The Impact of Policies Regarding E-cigarette(Trial) on Adolescents and Young Adults' Cognition and Behavior for E-cigarette: A Convergent Parallel Mixed-method Study Based on KABP Model.
Based on the Knowledge，Attitude，Belief and Practice model(KABP model), this study intends to use a mixed method to explore the influencing mechanism of youth and adolescents' cognition and behavior for e-cigarette before and after the promulgation of the new regulations on e-cigarette . Information from network epidemiology (including network links, text, images, audio, video, etc.) was captured to expand the data abundance, and the retrieval behavior of e-cigarettes and the trajectory changes of e-cigarette-related events were explored. Finally, summarize the data, integrate and explain the influencing mechanism of youth and adolescents' attention and cognition on e-cigarette, and provide ideas for subsequent e-cigarette control, as well as theoretical and practical basis for relevant departments to formulate corresponding policies.
Read the detailed description
Mixed method will be used: the cross-sectional surveys will be conducted on the demographic characteristics, e-cigarette use intentions, e-cigarette use behaviors, attitudes towards e-cigarette , knowledge of e-cigarette harm, reasons for using e-cigarette and the degree of understanding of the new regulations on e-cigarette control ; semi-structured interviews will be conducted with some young people and adolescents interviewed by using phenomenology and qualitative research methods, and the content of the interview will be summarized and analyzed. The primary and secondary categories and dimensions are coded; the analysis results of quantitative data and qualitative data are combined to explain the influencing mechanism of the trial implementation of e-cigarette regulatory regulations on youth and adolescents' cognition of electronic cigarettes and changes in their use behaviors.
Using the network epidemiological method, use the "drop-down word deep mining function" of the 5188 marketing big data website to obtain the relevant keywords of "electronic cigarette", and use the Baidu index and 360 index tools to explore the retrieval behavior of electronic cigarettes and related electronic cigarettes Event trace changes.
Combined with online epidemiological data and mixed method study results, summarize the changes in youth and adolescents' cognition and use of e-cigarettes before and after the promulgation of the new regulations, and provide a theoretical basis for formulating e-cigarette control policies in the future.
- Conditions
- E-Cig Use
- Being tested
- Questionnaires set
- Keywords
- Adolescent, Young adult, Policy, Surveys and questionnaires, Qualitative study, Electronic Nicotine Delivery Systems, KABP model, Network epidemiology
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires setOther
Participants will be asked to respond to the demographic information sheet,e-cigarette using characteristics sheet,awareness of e-cigarettes sheet;,willingness to use e-cigarettes sheet, knowledge, attitudes and cognitions related to e-cigarettes sheet, awareness of new regulations on e-cigarette control sheet.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires assessed adolescents and young adults | ①14-35 years old; ②Being able to read and communicate in Chinese. Receives: Other: Questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of e-cigarette use
Measured by the questionnaire including the following items:e-cigarette use, the daily amount of e-cigarette, the age of first e-cigarette use, the reasons for first e-cigarette use, the place where participant first smoked e-cigarette, e-cigarette dependence , the type and amount of other tobacco products used and the daily smoking place.
Measured: Baseline
Change of e-cigarette use
Measured by the questionnaire including the following items:e-cigarette use, the daily amount of e-cigarette, the age of first e-cigarette use, the reasons for first e-cigarette use, the place where participant first smoked e-cigarette, e-cigarette dependence , the type and amount of other tobacco products used and the daily smoking place.
Measured: 6 month follow up
Change of knowledge,attitudes and cognitions related to e-cigarette
The questionnaire items were compiled according to the literature review content, and the questionnaire contained 20 items in total. Six items were related to e-cigarette knowledge, five items are related to the susceptibility of e-cigarettes,eight items are related to the perceived harmfulness of e-cigarettes, one item is related to the perceived relative risk.
Measured: Baseline
Change of knowledge,attitudes and cognitions related to e-cigarette
The questionnaire items were compiled according to the literature review content, and the questionnaire contained 20 items in total. Six items were related to e-cigarette knowledge, five items are related to the susceptibility of e-cigarettes,eight items are related to the perceived harmfulness of e-cigarettes, one item is related to the perceived relative risk.
Measured: 6 month follow up
Change of awareness of new regulations on e-cigarette control
Measured by a yes-or-no question in the questionnaire，and those who answered yes can be considered to be aware of e-cigarette regulations.
Measured: Baseline
Change of awareness of new regulations on e-cigarette control
Measured by a yes-or-no question in the questionnaire，and those who answered yes can be considered to be aware of e-cigarette regulations.
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 posted1 Aug 2022
- Study start27 May 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Other
- Enrolment
- 453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482581
- Sponsor's protocol ID
- wjn-ChiCTR2200060895
- Status last verified
- Feb 2023
- First submitted
- 24 Jul 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified individual participant data will be shared after the outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Policies Regarding E-cigarette(Trial) on Adolescents and Young Adults' Cognition and Behavior for E-cigarette: A Convergent Parallel Mixed-method Study Based on KABP Model.
- ClinicalTrials.gov ID
- NCT05482581
- Acronym / sponsor ID
- wjn-ChiCTR2200060895
- Conditions
- E-Cig Use
- Keywords
- Adolescent, Young adult, Policy, Surveys and questionnaires, Qualitative study, Electronic Nicotine Delivery Systems, KABP model, Network epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 453 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 1 Aug 2022 (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.
Based on the Knowledge，Attitude，Belief and Practice model(KABP model), this study intends to use a mixed method to explore the influencing mechanism of youth and adolescents' cognition and behavior for e-cigarette before and after the promulgation of the new regulations on e-cigarette . Information from network epidemiology (including network links, text, images, audio, video, etc.) was captured to expand the data abundance, and the retrieval behavior of e-cigarettes and the trajectory changes of e-cigarette-related events were explored. Finally, summarize the data, integrate and explain the influencing mechanism of youth and adolescents' attention and cognition on e-cigarette, and provide ideas for subsequent e-cigarette control, as well as theoretical and practical basis for relevant departments to formulate corresponding policies.
Detailed description
Mixed method will be used: the cross-sectional surveys will be conducted on the demographic characteristics, e-cigarette use intentions, e-cigarette use behaviors, attitudes towards e-cigarette , knowledge of e-cigarette harm, reasons for using e-cigarette and the degree of understanding of the new regulations on e-cigarette control ; semi-structured interviews will be conducted with some young people and adolescents interviewed by using phenomenology and qualitative research methods, and the content of the interview will be summarized and analyzed. The primary and secondary categories and dimensions are coded; the analysis results of quantitative data and qualitative data are combined to explain the influencing mechanism of the trial implementation of e-cigarette regulatory regulations on youth and adolescents' cognition of electronic cigarettes and changes in their use behaviors.
Using the network epidemiological method, use the "drop-down word deep mining function" of the 5188 marketing big data website to obtain the relevant keywords of "electronic cigarette", and use the Baidu index and 360 index tools to explore the retrieval behavior of electronic cigarettes and related electronic cigarettes Event trace changes.
Combined with online epidemiological data and mixed method study results, summarize the changes in youth and adolescents' cognition and use of e-cigarettes before and after the promulgation of the new regulations, and provide a theoretical basis for formulating e-cigarette control policies in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed adolescents and young adults | – | Other: Questionnaires set①14-35 years old; ②Being able to read and communicate in Chinese. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Using an online and offline multi-channel model, participants who meet the eligibility criteria are invited to join the study.
Key inclusion criteria (2 listed)
- 14-35 years old;
- Being able to read and write in Chinese.
Key exclusion criteria (1 listed)
- Those who are unable to communicate due to serious mental or physical illnesses such as deafness, unclear consciousness due to mental illness, etc.
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 |
|---|---|---|
| Questionnaires setParticipants will be asked to respond to the demographic information sheet,e-cigarette using characteristics sheet,awareness of e-cigarettes sheet;,willingness to use e-cigarettes sheet, knowledge, attitudes and cognitions related to e-cigarettes sheet, awareness of new regulations on e-cigarette control sheet. | Other | Questionnaires assessed adolescents and young adults |
Primary outcome
Change of e-cigarette use
Time frame: Baseline
Measured by the questionnaire including the following items:e-cigarette use, the daily amount of e-cigarette, the age of first e-cigarette use, the reasons for first e-cigarette use, the place where participant first smoked e-cigarette, e-cigarette dependence , the type and amount of other tobacco products used and the daily smoking place.
Change of e-cigarette use
Time frame: 6 month follow up
Measured by the questionnaire including the following items:e-cigarette use, the daily amount of e-cigarette, the age of first e-cigarette use, the reasons for first e-cigarette use, the place where participant first smoked e-cigarette, e-cigarette dependence , the type and amount of other tobacco products used and the daily smoking place.
Change of knowledge,attitudes and cognitions related to e-cigarette
Time frame: Baseline
The questionnaire items were compiled according to the literature review content, and the questionnaire contained 20 items in total. Six items were related to e-cigarette knowledge, five items are related to the susceptibility of e-cigarettes,eight items are related to the perceived harmfulness of e-cigarettes, one item is related to the perceived relative risk.
Change of knowledge,attitudes and cognitions related to e-cigarette
Time frame: 6 month follow up
The questionnaire items were compiled according to the literature review content, and the questionnaire contained 20 items in total. Six items were related to e-cigarette knowledge, five items are related to the susceptibility of e-cigarettes,eight items are related to the perceived harmfulness of e-cigarettes, one item is related to the perceived relative risk.
Change of awareness of new regulations on e-cigarette control
Time frame: Baseline
Measured by a yes-or-no question in the questionnaire，and those who answered yes can be considered to be aware of e-cigarette regulations.
Change of awareness of new regulations on e-cigarette control
Time frame: 6 month follow up
Measured by a yes-or-no question in the questionnaire，and those who answered yes can be considered to be aware of e-cigarette regulations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Yes. The non-identified individual participant data will be shared after the outcomes have been published.
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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.
Wei Xia, PhD principal investigator
Sun Yat-sen University
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 E-Cig Use, run by Sun Yat-sen University 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 2 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 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 Wei Xia, PhD (18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of e-cigarette use (time frame: Baseline). The study lists 6 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 10 Feb 2023.