N/A
Completed N=1,721
Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath
Source: ClinicalTrials.gov NCT04843501 ↗Enrolled (actual)
1,721
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Number of Students Who Currently Use E-cigarettes — 9; 4 Participants
Summary
This is a two-arm, cluster randomized trial designed to to evaluate the effectiveness of an e-cigarette curriculum [called the CATCH My Breath (CMB) program] in delaying the onset of e-cigarette use in middle schoolers. Schools will be assigned to either the CMB program or usual care, which is Texas Education Agency (TEA) required tobacco prevention program. 10 schools will be assigned to each arm arm, and each school will include 70 students in the study, for a total of 700 students per arm and 1400 total students in the study. Both programs will be administered to participating students over 3 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Students Who Currently Use E-cigarettes |
5; 1 | — |
| PRIMARY Number of Students Who Currently Use E-cigarettes |
5; 1 | — |
| PRIMARY Number of Students Who Have Ever Used E-cigarettes in Their Lifetime |
27; 25 | — |
| PRIMARY Number of Students Who Have Ever Used E-cigarettes in Their Lifetime |
27; 25 | — |
| PRIMARY Number of Students Who Are Susceptible to E-cigarette Use |
171; 95 | — |
| PRIMARY Number of Students Who Are Susceptible to E-cigarette Use |
171; 95 | — |
Eligibility Criteria
School Inclusion Criteria:
- enrollment of at least 70 students in each of the 6th, 7th, and 8th grades
- school location is 100 miles of research site
School Exclusion Criteria:
- schools that have participated in the previous 2 pilot tests
- currently implementing CMB
Student Inclusion Criteria:
- enrollment in the 6th grade at a study school
- willingness to complete the measurements six times during the study
Student Exclusion Criteria:
- severe disabilities that limit their participation
Parent Inclusion Criteria:
- ability to communicate in English or Spanish
- caretaker of a 6th-grade child.
Parent Exclusion Criteria:
-inability to communicate in English or Spanish
Data sourced from ClinicalTrials.gov (NCT04843501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.