Trial Outcomes & Findings for Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath (NCT NCT04843501)
NCT ID: NCT04843501
Last Updated: 2026-02-06
Results Overview
Current use is defined as e-cigarette use in the last 30 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2059 participants
Primary outcome timeframe
baseline
Results posted on
2026-02-06
Participant Flow
Of the 2059 participants enrolled in the study, 5 participants withdrew before starting the study. Eligible individuals could enroll at the start of any semester. Participation was not required to be continuous, and participant numbers varied by semester.
Unit of analysis: Schools
Participant milestones
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Fall 2021
STARTED
|
1110 12
|
611 10
|
|
Fall 2021
COMPLETED
|
1110 12
|
611 10
|
|
Fall 2021
NOT COMPLETED
|
0 0
|
0 0
|
|
Spring 2022
STARTED
|
892 12
|
457 10
|
|
Spring 2022
COMPLETED
|
892 12
|
457 10
|
|
Spring 2022
NOT COMPLETED
|
0 0
|
0 0
|
|
Fall 2022
STARTED
|
859 12
|
406 10
|
|
Fall 2022
COMPLETED
|
859 12
|
406 10
|
|
Fall 2022
NOT COMPLETED
|
0 0
|
0 0
|
|
Spring 2023
STARTED
|
898 12
|
434 10
|
|
Spring 2023
COMPLETED
|
898 12
|
434 10
|
|
Spring 2023
NOT COMPLETED
|
0 0
|
0 0
|
|
Fall 2023
STARTED
|
755 12
|
412 10
|
|
Fall 2023
COMPLETED
|
755 12
|
412 10
|
|
Fall 2023
NOT COMPLETED
|
0 0
|
0 0
|
|
Spring 2024
STARTED
|
533 12
|
301 10
|
|
Spring 2024
COMPLETED
|
533 12
|
301 10
|
|
Spring 2024
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath
Baseline characteristics by cohort
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=1332 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=727 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
Total
n=2059 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1332 Participants
n=192 Participants
|
727 Participants
n=170 Participants
|
2059 Participants
n=185 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
|
Sex/Gender, Customized
Female
|
643 Participants
n=192 Participants
|
352 Participants
n=170 Participants
|
995 Participants
n=185 Participants
|
|
Sex/Gender, Customized
Male
|
672 Participants
n=192 Participants
|
364 Participants
n=170 Participants
|
1036 Participants
n=185 Participants
|
|
Sex/Gender, Customized
Unknown or Not Reported
|
17 Participants
n=192 Participants
|
11 Participants
n=170 Participants
|
28 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
784 Participants
n=192 Participants
|
388 Participants
n=170 Participants
|
1172 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
531 Participants
n=192 Participants
|
328 Participants
n=170 Participants
|
859 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=192 Participants
|
11 Participants
n=170 Participants
|
28 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
22 Participants
n=192 Participants
|
14 Participants
n=170 Participants
|
36 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=192 Participants
|
31 Participants
n=170 Participants
|
83 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=192 Participants
|
4 Participants
n=170 Participants
|
12 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
142 Participants
n=192 Participants
|
91 Participants
n=170 Participants
|
233 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
434 Participants
n=192 Participants
|
259 Participants
n=170 Participants
|
693 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
175 Participants
n=192 Participants
|
105 Participants
n=170 Participants
|
280 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
499 Participants
n=192 Participants
|
223 Participants
n=170 Participants
|
722 Participants
n=185 Participants
|
|
Region of Enrollment
United States
|
1332 participants
n=192 Participants
|
727 participants
n=170 Participants
|
2059 participants
n=185 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: Participants who reported ever using e-cigarettes at baseline were included in the analysis for this outcome measure.
Current use is defined as e-cigarette use in the last 30 days.
Outcome measures
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=37 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=17 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Number of Students Who Currently Use E-cigarettes
|
9 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Participants who reported ever using e-cigarettes at 3 years were included in the analysis for this outcome measure.
Current use is defined as e-cigarette use in the last 30 days.
Outcome measures
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=27 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=25 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Number of Students Who Currently Use E-cigarettes
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: baselineOutcome measures
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=1332 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=727 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Number of Students Who Have Ever Used E-cigarettes in Their Lifetime
|
37 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=533 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=301 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Number of Students Who Have Ever Used E-cigarettes in Their Lifetime
|
27 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: Participants who indicated they have never used an e-cigarette were assessed for this outcome. Data were only collected for participants who answered the questions.
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.
Outcome measures
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=1034 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=528 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Number of Students Who Are Susceptible to E-cigarette Use
|
357 Participants
|
171 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Participants who indicated they have never used an e-cigarette were assessed for this outcome. Data were only collected for participants who answered the questions.
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.
Outcome measures
| Measure |
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
n=490 Participants
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents: CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, 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 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
n=262 Participants
The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.
Texas Education Agency (TEA) required tobacco prevention program: 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'
|
|---|---|---|
|
Number of Students Who Are Susceptible to E-cigarette Use
|
171 Participants
|
95 Participants
|
Adverse Events
CATCH My Breath (CMB) Program for E-cigarette Prevention Among Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Texas Education Agency Required Tobacco Prevention Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steven H Kelder, PhD, MPH
The University of Texas Health Science Center at Houston
Phone: 713-444-1470
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place