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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05482581
Other study ID # wjn-ChiCTR2200060895
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 27, 2022
Est. completion date February 1, 2024

Study information

Verified date February 2023
Source Sun Yat-sen University
Contact Wei Xia, PhD
Phone 18823359471
Email xiaw23@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 . 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 453
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 35 Years
Eligibility Inclusion Criteria: - 14-35 years old; - Being able to read and write in Chinese. Exclusion Criteria: - Those who are unable to communicate due to serious mental or physical illnesses such as deafness, unclear consciousness due to mental illness, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires set
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.

Locations

Country Name City State
China XIAW Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. 6 month follow up
Primary 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. Baseline
Primary 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. 6 month follow up
Primary 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. Baseline
Primary 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. 6 month follow up
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