- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05493982
Evaluation of the Be Vape Free Curriculum of the Tobacco Prevention Toolkit
May 21, 2026 updated by: Bonnie Halpern-Felsher, Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2779
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Middle school and high school students receiving health education at schools participating in the study
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Receives Stanford vaping prevention curriculum (pilot phase)
Stanford vaping prevention curriculum is administered as pilot arm preceding main experimental intervention.
|
Stanford vaping prevention curriculum delivered as a 5-session course administered in a school classroom setting.
|
|
Experimental: Receives Stanford vaping prevention curriculum (randomized phase)
Stanford vaping prevention curriculum is administered.
|
Stanford vaping prevention curriculum delivered as a 5-session course administered in a school classroom setting.
|
|
No Intervention: Does not receive Stanford vaping prevention curriculum (randomized phase)
Receives another curriculum or no vaping prevention education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in e-cigarette use
Time Frame: Change from baseline to follow-up at approximately 156 weeks
|
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
|
|
Change in intention to use of e-cigarettes scaled score as measured by investigator-originated survey
Time Frame: Change from baseline to follow-up at approximately 156 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bonnie Halpern-Felsher, Ph.D., Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2022
Primary Completion (Actual)
May 8, 2026
Study Completion (Actual)
May 8, 2026
Study Registration Dates
First Submitted
August 6, 2022
First Submitted That Met QC Criteria
August 6, 2022
First Posted (Actual)
August 9, 2022
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 61965
- 1R01CA263121 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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