Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath

NCT04843501 | Completed Results

• 2 other identifiers: HSC-SPH-18-02545R01CA242171-02
• Study Type: interventional
• Target: 2,059
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

E-cigarette Use

Keywords

E-cigarette Prevention

Outcome Measures

Primary Outcomes (6)

• Number of Students Who Currently Use E-cigarettes

  Current use is defined as e-cigarette use in the last 30 days.

  baseline

• Number of Students Who Currently Use E-cigarettes

  Current use is defined as e-cigarette use in the last 30 days.

  3 years

• Number of Students Who Have Ever Used E-cigarettes in Their Lifetime

  baseline

• Number of Students Who Have Ever Used E-cigarettes in Their Lifetime

  3 years

• Number of Students Who Are Susceptible to E-cigarette Use

  Susceptibility to e-cigarette use is defined as never used an e-cigarette but having tendencies that indicate that e-cigarette use is likely. Susceptibility is assessed with a questionnaire that asks "Do any of your friends use e-cigarettes?," "Are you curious about e-cigarettes?," and "Do you think you will try an e-cigarette in the next year?" Yes to any of these three questions indicates susceptibility to e-cigarette use.

  baseline

• Number of Students Who Are Susceptible to E-cigarette Use

  Susceptibility to e-cigarette use is defined as never used an e-cigarette but having tendencies that indicate that e-cigarette use is likely. Susceptibility is assessed with a questionnaire that asks "Do any of your friends use e-cigarettes?," "Are you curious about e-cigarettes?," and "Do you think you will try an e-cigarette in the next year?" Yes to any of these three questions indicates susceptibility to e-cigarette use.

  3 years

Study Arms (2)

CATCH My Breath (CMB) program for E-cigarette prevention among adolescents

EXPERIMENTAL

The CMB curriculum is divided into four developmentally appropriate e-cigarette lessons (approximately 20-30 minutes each) for middle school aged youth (6th - 8th grade). A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, and goal setting. CMB will provide study materials to teachers and schools through a state-of-the art online delivery portal. A site-based management team will oversee program implementation. Teachers will be trained via webinar. Project staff will visit all participating schools to assemble and train the CATCH site-based management team, and answer questions about the study. Teachers in CMB intervention schools will be provided with CMB-specific training for implementing the lessons with fidelity through a one-hour live webinar with Dr. Kelder, which will be offered at multiple times to accommodate teaching schedules.

Behavioral: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents

Texas Education Agency required tobacco prevention program

ACTIVE COMPARATOR

The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.

Behavioral: Texas Education Agency (TEA) required tobacco prevention program

Interventions

CATCH My Breath (CMB) program for E-cigarette prevention among adolescents BEHAVIORAL

CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. Strategies include small and large group discussions, parent interviews, role-plays, media literacy, and goal setting. E-cigarette focused science and humanities activities (2 per school year) are also provided. An informational tool kit will be provided to parents. Finally, 8 activity-based E-cig PE lessons are intended for either 7th or 8th grades, depending on school calendar. CMB provides study materials to teachers through an online access portal. A site-based management team will oversee program implementation. Teachers in CMB intervention schools will be provided with CMB-specific training for implementing the lessons with fidelity through a one-hour live webinar, offered at multiple times to accommodate teaching schedules. Project staff will meet routinely with participating schools to answer study questions.

CATCH My Breath (CMB) program for E-cigarette prevention among adolescents

Texas Education Agency (TEA) required tobacco prevention program BEHAVIORAL

The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes TEA developed online lessons and support materials and also includes elements of the CDC Know the Risks e-cigarette prevention program. This can be considered 'usual care'

Texas Education Agency required tobacco prevention program

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• enrollment of at least 70 students in each of the 6th, 7th, and 8th grades
• school location is 100 miles of research site

You may not qualify if:

• schools that have participated in the previous 2 pilot tests
• currently implementing CMB
• enrollment in the 6th grade at a study school
• willingness to complete the measurements six times during the study
• \- severe disabilities that limit their participation
• ability to communicate in English or Spanish
• caretaker of a 6th-grade child.
• inability to communicate in English or Spanish

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston School of Public Health at Austin

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Tea

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Steven H Kelder, PhD, MPH
• Organization: The University of Texas Health Science Center at Houston

Steven.H.Kelder@uth.tmc.edu

713-444-1470

Study Officials

• Steven H Kelder, PhD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 10 schools will receive the experimental CATCH My Breath program and 10 schools will receive the usual care Texas Education Agency required tobacco prevention program. Each school will include 70 students.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: December 13, 2020
• Primary Completion: December 20, 2024
• Study Completion: December 30, 2024
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)