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NCT05493982 Clinical Trial

Evaluation of the Be Vape Free Curriculum of the Tobacco Prevention Toolkit

E-cigarette Use Clinical Trial

Official title:
Evaluation of the Be Vape Free Curriculum of the Tobacco Prevention Toolkit

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05493982
Other study ID # 61965
Secondary ID 1R01CA263121
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date May 29, 2026

Study information
Verified date September 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. A set of lessons focused on e-cigarette/vaping prevention education specifically is called the Be Vape Free curriculum. The aims of this study are to determine: (1) whether the Be Vape Free curriculum is effective in increasing middle and high school students' resistance to using tobacco and in decreasing positive attitudes towards and intentions to use e-cigarettes; (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco; and (3) Examine heterogenous treatment effects identifying groups that benefit the most and those who do not benefit at all from the intervention.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10800
Est. completion date May 29, 2026
Est. primary completion date May 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 20 Years
Eligibility Inclusion Criteria: Middle school and high school students receiving health education at schools participating in the study Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Stanford Vaping Prevention curriculum
Stanford vaping prevention curriculum delivered as a 5-session course administered in a school classroom setting.

Locations
Country Name City State
United States Stanford University Palo Alto California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in e-cigarette use Investigator-originated survey measures (questions) assess ever e-cigarette use & past 30-day tobacco use. This outcome measure assesses e-cigarette use. Change from baseline to follow-up at approximately 156 weeks
Primary Change in intention to use of e-cigarettes scaled score as measured by investigator-originated survey This survey measures change in intention to use e-cigarettes with questions related to the participant's knowledge of and resistance to use of e-cigarettes. Change from baseline to follow-up at approximately 156 weeks
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