NCT06825338

Brief Summary

Vapes (also called e-cigarettes) have increased in popularity among youth in Canada and the United States. Youth who try vaping are at risk of becoming addicted and continuing to vape. To help combat the rise in vaping, there is an urgent need to identify effective ways to prevent youth from experimenting with vaping. Because of the novelty of vapes, there are few school-based programs targeting vaping. This study will investigate whether a vaping prevention curriculum called 'CATCH My Breath' (CMB) prevents high school students from starting to vape. The investigators will recruit 28 schools in Ontario, Canada into the intervention group, and students at these schools will be presented with the CMB curriculum by Public Health Unit staff. CMB is an evidence-based program that includes two 60-minute lessons that provide students with information about social norms related to vaping, health risks of vaping, media literacy, and in-class activities to practice refusal skills. Students will complete an online survey before being exposed to the curriculum, 3-months later, and 12-months later. The vaping behaviours of these students will be compared to students in a separate study of youth health (i.e., the COMPASS study) who are not given the curriculum. Evidence from this study will identify whether students exposed to CMB are less likely to start and continue vaping. If effective, CMB can be easily delivered in high schools across Canada in order to reduce the number of students who vape.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,600

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Oct 2025Apr 2028

First Submitted

Initial submission to the registry

February 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

October 3, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

February 7, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

Vaping PreventionAdolescentCATCH My BreathE-cigarette use

Outcome Measures

Primary Outcomes (1)

  • Number of participants that initiate vaping at 12-month follow-up

    One validated item will assess ever vaping: "Have you ever tried a vape, also known as an e-cigarette?", with response options 'Yes' and 'No'. This item is consistent with other youth health surveillance studies in Canada and the US and is already present in the COMPASS survey. The question will include a definition of vapes, including examples and images of common brands, to improve the validity of student responses. Students who respond 'No' at baseline will be categorized as 'Never vapers'. Students who never vaped at baseline who respond 'Yes' at follow-up will be categorized as 'Initiated vaping' (outcome of interest), while those who respond 'No' at follow-up will be categorized as 'Did not initiate vaping' (reference group).

    baseline and 12-month follow-up

Secondary Outcomes (3)

  • Change in susceptibility to future vaping from baseline to 12-month follow-up

    baseline and 12-month follow-up

  • Change in number of students reporting past 30-day vaping from baseline to 12-month follow-up

    baseline and 12-month follow-up

  • Change in knowledge of vaping-related harms from baseline to 3- and 12-month follow-up

    baseline, 3-month, and 12-month follow-up

Study Arms (2)

CATCH My Breath (CMB)

EXPERIMENTAL

CATCH My Breath (CMB) is a school-based vaping prevention curriculum based on best practices from earlier prevention studies that works by fostering social competence and social influence resistance skills. The curriculum design and content targets two key constructs of Social Cognitive Theory: self-efficacy and behavioural capacity (i.e., knowledge and skills). The curriculum provides students with knowledge of why and how to resist vaping. It is delivered through two 60-minute lessons by a trained Public Health Unit presenter. The curriculum lessons provide information about: 1) the physical, mental, and addiction risks associated with vaping, 2) social norms of vaping (e.g., most youth don't vape), 3) media literacy (e.g., how to recognize and decipher marketing of vapes), 4) strategies to resist and avoid vaping, 5)school and provincial policies about vaping. To solidify the content, in-class activities allow students to discuss what they are learning and practice refusal skills.

Other: CATCH My Breath

Comparison

NO INTERVENTION

In Ontario, the current Health and Physical Education curriculum does not include any vaping-specific information, leaving it up to the discretion of educators to decide what to teach and how. The study takes advantage of existing connections to the COMPASS study. The large sample of schools participating in the COMPASS study provides an ideal comparison group, eliminating the need to recruit schools for this condition and reducing costs. The COMPASS study collects information about changes to school programs, policies, and the built environment that may occur over time using the School Policies and Practices survey. This survey is completed annually by a school contact knowledgeable about the school's health-related programs and policies. School contacts are asked whether the school offers any programs that address vaping and tobacco use prevention/cessation. This information will be used to identify schools that have not implemented any vaping/tobacco use programs.

Interventions

CATCH My Breath (CMB) is a school-based vaping prevention curriculum based on best practices from earlier prevention studies that works by fostering social competence and social influence resistance skills. The curriculum design and content targets two key constructs of Social Cognitive Theory: self-efficacy and behavioural capacity (i.e., knowledge and skills). The curriculum provides students with knowledge of why and how to resist vaping. It is delivered through two 60-minute lessons by a trained Public Health Unit presenter. The curriculum lessons provide information about: 1) the physical, mental, and addiction risks associated with vaping, 2) social norms of vaping (e.g., most youth don't vape), 3) media literacy (e.g., how to recognize and decipher marketing of vapes), 4) strategies to resist and avoid vaping, 5)school and provincial policies about vaping. To solidify the content, in-class activities allow students to discuss what they are learning and practice refusal skills.

Also known as: Vaping prevention program, Vaping prevention curriculum
CATCH My Breath (CMB)

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • public and private schools in Ontario, English-speaking schools, include students in grades 9 through 12, operate in a standard school/classroom setting (i.e., not a virtual school)

You may not qualify if:

  • non-English speaking schools, virtual schools, currently using the CATCH My Breath vaping prevention curriculum
  • enrolled in the class in which the CATCH My Breath curriculum is being delivered
  • not enrolled in the class in which the CATCH My Breath curriculum is being delivered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hastings and Prince Edward District School Board

Belleville, Ontario, K8N3L3, Canada

Location

Keewatin-Patricia District School Board

Dryden, Ontario, P8N2Z6, Canada

Location

Rainy River District School Board

Fort Frances, Ontario, P9A1N3, Canada

Location

Lakefield College School

Lakefield, Ontario, K0L2H0, Canada

Location

Algonquin and Lakeshore Catholic District School Board

Napanee, Ontario, K7R4B2, Canada

Location

Renfrew County District School Board

Pembroke, Ontario, K8A4G4, Canada

Location

Thunder Bay Catholic District School Board

Thunder Bay, Ontario, P7C0A4, Canada

Location

Toronto District School Board

Toronto, Ontario, M2N7H3, Canada

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Adam Cole, PhD

    Ontario Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a two-arm quasi-experimental study. The study team will recruit schools that will implement the CATCH My Breath vaping prevention curriculum (intervention group). Results will be compared with a separate on-going study of youth health: the COMPASS study (comparison group). Schools recruited into the COMPASS study will not implement the CATCH My Breath vaping prevention curriculum.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 13, 2025

Study Start

October 3, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Student surveys: Anonymized data for students who have given permission for their data to be used for secondary research purposes and the associated Codebook will be uploaded to Borealis to be stored indefinitely at the end of the project following data analysis and publication. These anonymized data will be available only to specific individuals upon request. The requests will be reviewed and approved by the PI. Field Notes Survey: Anonymized data and the associated Codebook will be uploaded to Borealis to be stored indefinitely at the end of the project following data analysis and publication. These anonymized data will be available only to specific individuals upon request. The requests will be reviewed and approved by the PI. COMPASS data: Electronic data used for secondary data analysis will not be shared. Those interested in accessing COMPASS data can submit a Data Request Application to the PI of the COMPASS study.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD and supporting information will be uploaded to Borealis following data analysis and publication and will be stored indefinitely.
Access Criteria
Anonymized data for students who have given permission for their data to be used for secondary research purposes will be available only to specific individuals upon request. The requests will be reviewed and approved by the PI.

Locations