Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath
Phase: NA
Conditions: E-cigarette Use
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
 
 
 
 
 
 
 
 
 
 
 
Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath   
 
NCT04843501 
 
Version Date: 7/21/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
Protocol for Middle School Cluster RCT to Evaluate E-cigarette Prevention Program: 
CATCH My Breath 
 
 
Protocol Title: Middle School Cluster RCT to Evaluate E-cigarette Prevention Program: CATCH My Breath 
 
Principal Investigator: Steve Kelder, PhD 
 
Co-Investigators: Andrew Springer, DrPH; Baojiang Chen, PhD; MeLisa Creamer, PhD; Maria Cooper, 
PhD; Kathleen Case, DrPH 
 
Study Coordinator: TBD 
 
Population: 30 schools across the Texas 
 
Number of Sites: Single Site: UT School of Public Health - Austin Regional Campus 
 
Study Duration: September 1, 2018-August 30, 2023 
 
Subject Duration: September 1, 2019 - August 30, 2022 
 
 
General Information 
The primary purpose of this study is to empirically assess the three year effects of the CATCH My Breath 
(CMB) program on delaying the onset of e-cigarette use with a 6th-8th grade cohort, using a 30-school 
group randomized controlled trial (RCT), with 2,400 students. The CMB curriculum is divided into four 
sessions lasting approximately 20-30 minutes each. A variety of educational strategies are used and 
include cooperative learning groups, large group discussions, interviews, role-play, media, reports, and 
goal setting. 
 
The CMB program is based on well-established educational best practices and empirical evidence, and 
has been piloted tested for feasibility; feedback on the pilot program was received from 42 teachers and 
2,255 6th - 8th grade students. Pilot test results were largely favorable, and the program was revised 
based on findings from the pilot study. CMB is ready for a larger, RCT with teachers and students. 
 
Our ultimate goal is to bring scientifically accurate information to inform and educate teachers, parents 
and health professionals in the school/afterschool setting about the health risk of e-cigarettes. Our aim 
is to equip students with answers about e-cigarettes and to make informed decisions about the use of e- 
cigarettes. 
 
E-cigarette use is epidemic among middle school children, and schools have few rigorously prepared 
resources to educate students and families. Dr. Kelder is one of several scientific editors of the 
2016 Surgeon General Report on E-cigarette Use among Youth and Young Adults and is well versed in 
the health effects of e-cigarettes. Our goal is to rigorously evaluate the CMB program in order to 
provide educational agencies evidence-based resources to coincide with the recently released Surgeon 
General Report. 

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
 
Background Information 
E-cigarette consumption among youth is of concern because of the harmful effects of nicotine on 
human growth and development in terms of addiction and brain development, and fetal development 
among pregnant teenagers. The rapid increase in use among teens is of concern and portends the 
possibility of nationwide health consequences. The epidemic calls for a coordinated and scientifically 
accurate response. 
 
CMB will utilize the gold standard RCT approach to evaluate the effectiveness of the intervention. We 
will evaluate CMB using a cluster group randomized trial design comparing 15 usual care schools 
implementing Texas Education Agency required tobacco prevention objectives to 15 schools 
implementing the CMB program. We intend to measure children before and after implementation of 
the program to assess changes in knowledge, attitudes and intentions to use e-cigarettes. We will 
assess students with a brief survey tool, assess student likes and dislikes, judge the length of time to 
implement the curriculum, and assess teacher reactions to teaching the program. The effectiveness 
of CMB, and user experience, will be assessed mixed method qualitative and quantitative approaches, 
including: (a) the impact of CMB on student susceptibility to use e-cigarettes; (b) the impact of CMB on 
initiation of e-cigarette use (ever use); (c) the impact of CMB on intermediate program outcomes (such 
as harm perceptions, outcome expectations, self-efficacy); and (d) the feasibility, fidelity and dose of 
program implementation. 
 
CMB is a best-practice based program that was modeled after an evidence-based program called the 
Class of 1989 Study and elements from the Coordinated Approach to Child Health (CATCH) Program. 
Both the Class of 1989 and CATCH were NIH-funded studies, and both have statistically reliable research 
results. The Class of 1989 formally studied two communities and a school-based tobacco prevention 
program, which showed strong effects in reducing student smoking from 6th to 12th grade. CATCH 
studied children in 3rd to 8th grades and showed strong effects in improving student dietary intake and 
physical activity, and in later versions of the program, effects on child obesity. CMB was modified from 
the Class of 1989 tobacco prevention program and designed to be added to the CATCH portfolio of 
school health programs. The same study teams that worked on Class of 1989, and CATCH, have created 
the CMB program. 
 
CMB is also informed by new scientific literature on the rise in use of e-cigarettes in the United States, 
and the emerging science regarding the harmful consequences of e-cigarette use by preteens and  
teens. 
 
Objectives 
The objective of this study is to evaluate the effectiveness of an E-cigarette curriculum for middle 
school. The overall goal of CMB is to prevent E-cigarette use among adolescents. This study will be 
guided by the following aims: 
 
Aim 1. Quantify the direct program effect on susceptibility and first use of e-cigarettes on a 
cohort of children exposed to the CMB program in 6th, 7th, and 8th grades, compared to same- 
aged students in usual care schools. 
 
Hypothesis 1: After three school years of exposure to the CMB school-based prevention 
program, 8th-grade students in 15 intervention schools will report: (a) lowered susceptibility to 
use e-cigarettes; and (b) lowered first time (ever) use of e-cigarettes compared to students in 15 

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
comparison schools. 
 
Aim 2. Quantify the mediating effects of intermediate program outcomes (such as intentions to 
use, resistance skills, self-efficacy, and media literacy) to understand the mechanisms by which 
program effects occur. 
 
Hypothesis 2: After three school years of exposure to the CMB school-based prevention 
program, 8th-grade students in the 15 intervention schools will improve scores on intermediate 
program outcomes compared to students in the 15 comparison schools. 
 
Secondary Aim. Given the longitudinal study design and large number of student participants, 
we also intend to examine important secondary hypotheses to understand the nature of the e- 
cigarette epidemic, including nicotine addiction, transition to combustible tobacco use, and e- 
cigarette assisted marijuana use. 
 
We will also assess students knowledge, attitudes and possible experience with tobacco and e-cigarettes 
before and after they receive CMB through a pre-post survey. A subset of students, parents, and 
teachers will be invited to participate in focus groups to gather input for continuous quality 
improvements to the program and online delivery system. 
 
Study Design 
We will evaluate CMB using a cluster group RCT design comparing 15 usual care schools implementing 
Texas Education Agency required tobacco prevention objectives to 15 schools implementing 
the CMB program (a total of 30 schools). Thirty schools will be recruited from a pool of 188 public 
middle schools within 100 miles of The University of Texas School of Public Health in Austin, matched by 
key demographic variables (percent male and female, percent free and reduced lunch, percent race and 
ethnicity, percent English as second language) and randomized into intervention and comparison 
conditions. To ensure comparability, we will recruit 15 matched pairs of schools and randomize them 
into either treatment or control usual care conditions. 
 
There are no known risks associated with this study. The potential benefits include equipping 
adolescents with the appropriate knowledge and refusal skills for e-cigarettes. 
 
Study Population & Procedures 
The project will identify 30 Texas schools (at least one teacher and/or class per school) to evaluate the 
effectiveness of four developmentally appropriate e-cigarette lessons (approximately 20-30 minutes 
long) for middle school aged youth (6th 8th grade). Consistent with the RCT design, we will randomize 15 
usual care schools and 15 schools with CMB school-based prevention program with cluster size 80 in 
each school (total sample size = 2,400). We will exclude schools that have participated in our previous 2 
pilot tests, or are currently implementing CMB. 
 
The study team will draw a convenience sample from interested schools, who will then be matched and 
assigned to study conditions. School matching will be based on data available through the Texas 
Education Agency (TEA) online database and will include: the size of school, percent free and reduced 
price lunch, percent limited English proficiency, percent midyear student transfers, percent staff in 
school with less than five years experience, percent staff leaving midyear, percent passing state 
mandated reading and math tests, and attendance rate. 

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
A recruitment presentation, directed at the principal and a curriculum committee or another decision- 
making committee, will be delivered to interested schools. School recruitment and 
randomization will be done in Year 1 (July 18 June 19). Implementation of the curriculum will occur 
in Years 2-4 (Fall 19 Spring 22). Data analyses, presentations and manuscript developing will be ongoing 
in Years 2-5. We will obtain a Memorandum of Understanding (MOU) from each participating 
school which delineates responsibilities of the school and research team. Active parental consent will be 
obtained at back-to-school parent nights by inclusion of consent forms in the school packet of forms 
that parents sign at the beginning of the school year. For parents not in attendance, students will 
receive a recruitment packet to take home in the schools weekly take-home folder. Small incentives to 
schools ($500 stipend for a site coordinator) and students ($15-$20 for t-shirts, water bottles, etc) 
greatly facilitate return of consent forms, recruitment and retention. 
 
CMB will provide study materials to teachers and schools through a state-of-the art online delivery 
portal. Teachers will access CMB program materials and resources through the CATCH digital access 
portal (www.digitalcatch.org), built with Ruby on Rails, a highly scalable, efficient and popular web 
application framework. 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. 
 
All student assessments (1 pre-test and 5 follow-up tests) will be conducted online to improve reliability 
and validity of the survey. Online assessments offer a variety of strengths including utilizing skip 
patterns, which decrease survey burden; presenting pictures of the products, which increases validity; 
and providing increased confidentiality in answers that paper surveys cannot provide. In addition to 
basic demographic information, data will be collected on e-cigarette use behaviors, susceptibility to e- 
cigarettes, addiction to and dependence on nicotine and e-cigarettes; risk perceptions, reasons to use or 
not to use, perceived prevalence, normative beliefs, outcome expectations, self-efficacy to resist use 
(intermediate outcomes); and additional covariates and exploratory factors that include peer and 
parental use of tobacco products, other tobacco use behaviors, and marijuana and alcohol use 
behaviors. 
 
CMB will also provide assessment to teachers and site coordinators at both intervention and at usual care 
schools to measure implementation of the CMB program and usual care program. All teacher and site 
coordinator assessment will be conducted online to improve reliability and validity of the survey. The online 
questionnaire will collect data on basic demographic; what program was taught (usual care schools) and 
validate the CMB program in the intervention schools; how the program was taught (as directed), how well 
the program was taught (training involved) and exploratory factors on the implementation of the programs 
taught in both intervention and usual care schools. This assessment will be done every school year of 
implementation. 
 
Data and Safety Monitoring 
No adverse events are expected. Unanticipated problems, to include protocol deviations, will be 
reported to the PI and IRB. Staff will receive training, certification, and retraining in consent procedures 
and data collection procedures to assure accurate information and confidentiality. The survey tool is 
very short and we anticipate will be completed by students in less than 8 minutes. 

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
Data Collection and Management: Research Electronic Data Capture (REDCap) was designed through 
NIH funding, specifically to provide research institutions with the ability to collect, house and process 
data in a secure platform. REDCap has Zone 100 security which is accepted by The University of Texas 
Health Science Center (UTHSC) to adhere to Health Insurance Portability and Accountability Act (HIPAA) 
and Federal Information Security Management Act (FISMA) compliance standards and is accessible from 
anywhere with Internet capability and useable offline on Android and iOS mobile devices. Along with 
offering a high level of security, REDCap also provides many advanced features such as branching logic, 
calculated fields, and file uploading as well as fully formatting data export directly into all of the major 
statistical packages. The data manager will utilize computer software to detect errors in the data files 
such as skip pattern error, duplicate or incorrect identification numbers, and inconsistent responses. To 
assure security of study data, weekly backup copies of the master file will be made and stored in a 
physically remote secure area. 
 
Statistics 
From each of the 30 schools, we will recruit 80 6th-grade students, for a total n=1,200 per study 
condition and 2,400 total students. Follow-up measurements will be conducted post-intervention in 
spring in 6th, and spring and fall in 7th and 8th grades, for a total of 6 measurements per student. 
 
Statistical analysis will follow state of art cluster randomized trial methodology. The statistical analysis 
will be conducted in four phases: (1) Descriptive Analysis, (2) Analysis of Aim 1, (3) Analysis of Aim 2, 
and (4) Secondary Exploratory Analyses. 
 
(1) Descriptive Analysis will be conducted with baseline data to produce a profile of demographics and 
baseline characteristics. Analysis will consist of descriptive statistics such as frequencies, means, cross- 
tabulations and graphical representation of data. Results will provide information on imbalances 
between treatment groups that should be accounted for in the confirmatory analysis. 
 
(2) Analysis of Hypothesis 1 is to test the proposed hypothesis that after three years exposure to 
the CMB school-based prevention program, 8th grade students in the intervention schools will report 
lower a) susceptibility to use e-cigarettes and b) ever e-cigarette use prevalence compared to students 
in the comparison schools. Multi-level regression models will be used to test for intervention effects 
while controlling for baseline differences through the use of covariates. Three-level hierarchical models 
will be used to assess the impact of the intervention where level 1 is the repeated measurement of 
individual students, level 2 is the student, and level 3 is the school. Multi-level models provide a 
powerful and flexible framework for the analysis of repeated measures data in the presence of possible 
cluster effects, allowing for the inclusion of subjects with incomplete data, thus maximizing power and 
minimizing the Type I error rate. 
 
(3) Analysis of Hypothesis 2 is to test the hypothesis that after three years exposure to the CMB school- 
based prevention program, 8th grade students in the intervention schools will improve scores on 
intermediate program outcomes compared to students in the comparison schools. Treating these 
variables as outcomes, we will employ the same statistical strategies as described in analysis of Aim 1. In 
addition, we will also analyze these intermediate variables as mediators of program effect to determine 
which act as a mechanism for explaining the effect of the intervention on the two primary outcomes 
(susceptibility and ever use).These analyses will allow further examination of these possibilities, and will 
build on the multi-level models developed for the analyses described in Aim 1. 
 
(4) Secondary Exploratory Analyses. Given the longitudinal study design, we intend to examine 

IRB NUMBER: HSC-SPH-18-0254 
IRB APPROVAL DATE: 07/21/2021 
 
important secondary hypotheses to understand the nature of the e-cigarette epidemic with the respect 
to nicotine dependence and progression to combustible tobacco, marijuana, and alcohol use. Multi-level 
regression models will be used to assess the longitudinal relationships between independent and 
dependent variables, while controlling for intervention effects, and baseline differences through the use 
of covariates. 
 
Ethics, data handling and record keeping 
For the school personnel questionnaires, consent will be inferred with the completion of each 
questionnaire. A coversheet will be attached to each survey describing the purpose, risks, and benefits 
of the self-report surveys. A personal identification number will be assigned to each survey 
participant to maintain anonymity. After the final confirmation at the end of the study, the names 
associated with the identification numbers will be destroyed. For the student measures, each student 
will receive a recruitment packet to take home to parents or guardians. Active parental consent will be 
obtained at parent back to school night by inclusion of consent forms in the school packet of forms that 
parents sign in the beginning of the year. Students will be assigned a personal identification to maintain 
anonymity. The names associated with the identification numbers will be destroyed after the final 
confirmation at the end of the study. No personal identification information (e.g., name, address, etc.) 
will be reported in any manuscript. 
 
Confidentiality of all subjects will be fully protected. All study records will be kept in locked file cabinets 
and secured computer files. Only aggregate data will be reported and released, and at no time will 
individual names appear in any report/article related to the study. 
 
Quality control and assurance 
All data will be collected and stored in secure rooms with secure computers following the UTHealth data 
storage and retrieval protocols, and the Michael & Susan Dell Center. Access to data will be managed by 
Dr. Kelder. 
 
Publication Plan 
We intend to publish at least one publication reporting the effectiveness of 
the CMB program. Participating schools will be given no-cost copies of the program for their future use 
and a copy of the pilot test report. Results will be reported in aggregate.