E-cigarette UseNCT04843501
Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath
A study testing CATCH My Breath (CMB) program for E-cigarette prevention among adolescents and Texas Education Agency (TEA) required tobacco prevention program in people with E-cigarette Use, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarette Use
- What is being tested?
- CATCH My Breath (CMB) program for E-cigarette prevention among adolescents and Texas Education Agency (TEA) required tobacco prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,059 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2020to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston School of Public Health at Austin
Austin, Texas, 78701
About this study
Official title: Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath
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.
Read the detailed description
The goal of this research is to empirically assess the three year immediate effects and 12 year follow-up of the CATCH My Breath (CMB) program on delaying the onset of e-cigarette use with a 6th-9th grade cohort, using a 20-school group randomized controlled trial (RCT), with 1,400 students. E-cigarettes are the most commonly used tobacco product by US youth. Recent research, strongly suggests that youth who only smoke e-cigarettes exhibit symptoms of addiction, and are more likely to experiment combustible tobacco. Unfortunately, few e-cigarette prevention programs exist, and none have been tested for longer-term efficacy. Although some tobacco prevention programs have included an e-cigarette add -on component, to our knowledge, none of these revised programs have been formally evaluated. The lack of e-cigarette specific program content, and lack of rigorous evaluation, warrants the proposed project. CMB was developed with input from school administrators, health education coordinators, tobacco prevention educators, classroom teachers, students, and parents. CMB has been formatively evaluated and pilot tested at 59 middle schools in 7 states, resulting in positive feedback from over 100 middle school teachers and 9,578 6th-8th grade students. Our second pilot pretest-posttest controlled experiment (2017-2018), and resulted in an treatment-control difference of 3.8% in ever smoking over a 16-month period. Given CMB's current popularity with schools as a 'best practice' program, and with initial positive results, a full scale randomized control trial is needed to determine longer term, 6th-9th grade efficacy.
- Conditions
- E-cigarette Use
- Being tested
- CATCH My Breath (CMB) program for E-cigarette prevention among adolescents, Texas Education Agency (TEA) required tobacco prevention program
- Keywords
- E-cigarette Prevention
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATCH My Breath (CMB) program for E-cigarette prevention among adolescentsBehavioural
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.
Texas Education Agency (TEA) required tobacco prevention programBehavioural
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'
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Texas Education Agency (TEA) required tobacco prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Students Who Currently Use E-cigarettes
Current use is defined as e-cigarette use in the last 30 days.
Measured: baseline
Number of Students Who Currently Use E-cigarettes
Current use is defined as e-cigarette use in the last 30 days.
Measured: 3 years
Number of Students Who Have Ever Used E-cigarettes in Their Lifetime
Measured: baseline
Number of Students Who Have Ever Used E-cigarettes in Their Lifetime
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start13 Dec 2020
- Primary completion20 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for E-cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steven H. Kelder, The University of Texas Health Science Center, Houston
- Investigators
- Steven H Kelder, PhD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843501
- Sponsor's protocol ID
- HSC-SPH-18-0254
- Other IDs
- 5R01CA242171-02
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2021
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath
- ClinicalTrials.gov ID
- NCT04843501
- Acronym / sponsor ID
- HSC-SPH-18-0254
- Conditions
- E-cigarette Use
- Keywords
- E-cigarette Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,059 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this research is to empirically assess the three year immediate effects and 12 year follow-up of the CATCH My Breath (CMB) program on delaying the onset of e-cigarette use with a 6th-9th grade cohort, using a 20-school group randomized controlled trial (RCT), with 1,400 students. E-cigarettes are the most commonly used tobacco product by US youth. Recent research, strongly suggests that youth who only smoke e-cigarettes exhibit symptoms of addiction, and are more likely to experiment combustible tobacco. Unfortunately, few e-cigarette prevention programs exist, and none have been tested for longer-term efficacy. Although some tobacco prevention programs have included an e-cigarette add -on component, to our knowledge, none of these revised programs have been formally evaluated. The lack of e-cigarette specific program content, and lack of rigorous evaluation, warrants the proposed project. CMB was developed with input from school administrators, health education coordinators, tobacco prevention educators, classroom teachers, students, and parents. CMB has been formatively evaluated and pilot tested at 59 middle schools in 7 states, resulting in positive feedback from over 100 middle school teachers and 9,578 6th-8th grade students. Our second pilot pretest-posttest controlled experiment (2017-2018), and resulted in an treatment-control difference of 3.8% in ever smoking over a 16-month period. Given CMB's current popularity with schools as a 'best practice' program, and with initial positive results, a full scale randomized control trial is needed to determine longer term, 6th-9th grade efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CATCH My Breath (CMB) program for E-cigarette prevention among adolescents | Experimental | Behavioral: CATCH My Breath (CMB) program for E-cigarette prevention among adolescentsThe 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. |
| Texas Education Agency required tobacco prevention program | Active comparator | Behavioral: Texas Education Agency (TEA) required tobacco prevention programThe TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATCH My Breath (CMB) program for E-cigarette prevention among adolescentsCMB 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. | Behavioural | CATCH My Breath (CMB) program for E-cigarette prevention among adolescents |
| Texas Education Agency (TEA) required tobacco prevention programThe 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' | Behavioural | Texas Education Agency required tobacco prevention program |
Primary outcome
Number of Students Who Currently Use E-cigarettes
Time frame: baseline
Current use is defined as e-cigarette use in the last 30 days.
Number of Students Who Currently Use E-cigarettes
Time frame: 3 years
Current use is defined as e-cigarette use in the last 30 days.
Number of Students Who Have Ever Used E-cigarettes in Their Lifetime
Time frame: baseline
Number of Students Who Have Ever Used E-cigarettes in Their Lifetime
Time frame: 3 years
Number of Students Who Are Susceptible to E-cigarette Use
Time frame: baseline
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.
Number of Students Who Are Susceptible to E-cigarette Use
Time frame: 3 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven H Kelder, PhD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATCH My Breath (CMB) program for E-cigarette prevention among adolescents and Texas Education Agency (TEA) required tobacco prevention program in people with E-cigarette Use, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Students Who Currently Use E-cigarettes (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.