Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
Phase: NA
Conditions: Physical Activity
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-SPH-20-0861 
IRB APPROVAL DATE: 10/22/2025 
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Developing and testing an implementation strategy for active learning to promote 
physical activity in children 
 
NCT05048433 
 
Version Date: 10/22/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-SPH-20-0861 
IRB APPROVAL DATE: 10/22/2025 
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Protocol Title: 
Developing and testing an implementation strategy for active learning to 
promote physical activity in children 
 
Principal Investigator: 
Timothy J. Walker, PhD 
 
Population: 
Phase 2: 85 Teachers/school staff and about 1100 elementary aged students 
 
Number of Sites: 
Single site 
 
Study Duration: 
4 years 
 
Subject Duration: 
1-2 years 
 
 
General Information 
This study will develop and examine the feasibility of using an implementation strategy for 
active learning, an evidence-based approach to promote children’s physical activity in schools. 
Developing and testing an implementation strategy for active learning is critical to support the scale-up 
of these approaches and maximize the public health impact. Dr. Walker is the Principal Investigator and 
he will receive guidance throughout the study from a mentoring team consisting of Drs. Maria 
Fernandez, Harold Kohl, Charles Green, and John Bartholomew. 
 
Background Information 
Recent research indicates only about 49% of boys and 36% of girls (aged 6-11 years) are meeting 
physical activity guideline recommendations.1 As low levels of physical activity in childhood track into 
adulthood, this puts a generation of children at an increased risk of cardiovascular disease. The 
American Heart Association recommends population-based physical activity approaches that start in 
early childhood for cardiovascular disease prevention.2 Despite existing evidence-based approaches that 
increase children’s physical activity, implementation remains a challenge, especially in schools. 
Schools are a critical setting for physical activity promotion given that they can reach close to 60 
million students across the United States.3 Furthermore, children spend the majority of their day in 
schools where they are becoming increasingly sedentary.4 This is because the educational landscape has 
shifted towards devoting more time to reading and math and less time to physical education and recess. 
One novel way educators are introducing additional physical activity back into the school day is by 
incorporating physical movement into academic lessons, an approach known as active learning. There 
are different forms of active learning that teachers can use. One is developing academic lessons that 
include physical movements as part of the lesson. For example, a teacher may have students do jumping 
jacks as part of a counting lesson. Teachers and school staff can also transform a space (e.g., an empty 
classroom) at each school to facilitate active learning lessons. These spaces (also known as motor labs) 
have ready-to-use equipment (usually set up in learning stations) that can be portable or remain set up 
to support teachers when delivering active lessons. For example, students may jump through a rope 
ladder while reading words in one station or jump on a trampoline 10 times while counting by 10s. 
Another form of active learning is incorporating physically active breaks during classroom time. These 

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breaks are not part of the lesson plan but can serve to supplement learning or provide a break from 
academic content. For example, after teacher delivers lesson content, they may take a break from the 
lesson material and do a themed dance, and then transition back to the next part of the lesson. There 
are many existing resources that teachers can use to facilitate these breaks such as GoNoodle, which is 
an online platform that has a library of videos to support physically active breaks. 
Research indicates active learning is a promising and effective way to improve children’s physical 
activity levels.5,6 However, these approaches are rarely disseminated and implemented to maximize the 
public health benefits.7,8 Therefore, there is an urgent need for the development of effective 
implementation strategies to improve the dissemination and implementation of active learning. Until 
this need is met, the delivery and scale-up of active learning will remain difficult, negatively impacting 
children’s physical activity levels, cardiovascular health, and well-being. 
The long-term goal of this work is to improve the implementation and scale-up of evidence-based 
physical activity approaches to prevent cardiovascular disease. The goals of this research are to: 1) 
develop a multifaceted implementation strategy for active learning, and 2) conduct a feasibility study to 
determine whether the developed implementation strategy warrants further testing. The rationale for 
this project is informed by current work with a local school district in Houston, Texas. The formative 
research indicates elementary schools are not providing adequate amounts of physical activity to 
students. Many teachers and staff believe active learning is an effective way to increase students’ 
physical activity levels when used appropriately; however, these approaches are often poorly 
implemented. Staff reported common implementation barriers consistent with existing research such as 
time, available resources, school culture, and competing demands.9-11 Thus, targeting barriers through a 
systematically developed implementation strategy is likely to improve delivery and effectiveness. 
 
Objectives 
The aims of this study are to: 
 
1) Develop an implementation strategy to improve the use and sustainment of active learning in 
elementary schools. We will use Intervention Mapping, a multi-step approach that includes stakeholder 
input, behavioral theories, and existing literature to develop a scientifically-based, multifaceted 
implementation strategy.12 
 
2) Conduct a feasibility study to evaluate the impact of the developed implementation strategy on 
the implementation and effectiveness of active learning. We will assess the acceptability of the 
implementation strategy and examine its impact on implementation (fidelity) by comparing results 
between an intervention school (school that receives the implementation strategy) and a comparison 
school. We will also examine the effectiveness of a specific active learning approach (Action-Based 
Learning) by comparing students’ physical activity levels over time and between an intervention and a 
comparison school. 
 
Study Design 
There are two phases to this study: 1) develop an implementation strategy and 
2) conduct a feasibility study to examine the acceptability and impact of the implementation strategy, 
and effectiveness of active learning. 

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For the phase 1 (aim 1), we will use Intervention Mapping (IM) to develop an implementation 
strategy for active learning. IM has been primarily used for developing effective behavioral 
interventions13-17 Recently, implementation researchers have discovered IM to be useful for 
implementation18,19 although IM has been used for this purpose since its inception.20 Intervention 
mapping is a process that involves fives steps for developing and selecting implementation strategies: 1) 
conduct a needs and assets assessment and identify adopters and implementers; 2) identify adoption 
and implementation outcomes, performance objectives, and determinants, create matrices of change; 
3) choose theoretical methods and select or create implementation strategies; 4) produce 
implementation protocols and materials; 5) evaluate implementation outcomes. The process is iterative 
to ensure all adopters and implementers, outcomes, determinants, and objectives are addressed. 
Given our recent research 21, we anticipate developing an implementation strategy consisting of (but 
not limited to): 1) staff trainings; 2) program champions; and 3) a positive reinforcement system. The 
trainings will target staff knowledge, buy-in, self-efficacy, and how to create/use a motor lab in a low 
resource environment. The program champion will help reduce teacher burden by maintaining the 
motor lab and providing ready-to-use lessons.22 The reinforcement system will target leadership support 
and culture. Overall, the implementation strategy will be designed to reduce existing barriers and 
provide ongoing support for teachers to maintain the use of active learning approaches. 
As an initial step, we will establish a planning group that will consist of teachers, school staff, school 
wellness professionals, and parents. The group will also include wellness leaders from other school 
districts to help ensure the strategy is generalizable. The group will work with the research team 
throughout the project and will help develop the implementation strategy. IM will also guide the use of 
theory and empirical evidence to identify: 1) implementers of active learning; 2) the behaviors 
implementers must perform (performance objectives); and 3) the determinants that influence these 
behaviors. We will draw on our preliminary studies, existing literature, and input from the planning 
group. The duration of the implementation strategy planning/development phase is expected to be 1 
year. 
For phase 2 (aim 2) we will conduct a feasibility study to determine whether the implementation 
strategy is appropriate for further testing.23 Our feasibility study will include acceptability and 
preliminary effectiveness testing, which are common for these types of studies.23 Our study is designed 
to determine: 1) whether using an implementation strategy can improve the delivery of active learning 
in schools; and 2) whether there is evidence active learning will increase students’ physical activity. By 
concurrently testing the implementation strategy and the effectiveness of active learning, we are using 
an approach known as a Hybrid Type 2 design.24 Hybrid designs are unique to implementation research 
given their duel focus on implementation and effectiveness.24 Hybrid Type 2 designs in particular, place 
equal emphasis on implementation and effectiveness outcomes. Thus, the primary study outcomes are: 
acceptability of active learning, implementation fidelity, and children’s physical activity levels. Additional 
study outcomes include implementation quality and adherence, teacher acceptability of the 
implementation strategy, student’s health related fitness, behavior, and academic performance. Data 
for some of the additional outcomes will be collected by schools. 
For the feasibility study, we will use a quasi-experimental pre-post design in two elementary 
schools: one school will be randomly selected to receive the developed implementation strategy, while 
the other will serve as a comparison school and receive usual implementation support. We will use a 
concurrent mixed methods approach to examine study outcomes.25More specifically, we will collect 

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qualitative and quantitative data to triangulate findings. The duration of the feasibility study phase is 
expected to be one to two years (schools involved for 2 years and teachers/students involved for 1-2 
years). 
 
Study Population 
Participating schools are expected to have about 40-45 teachers who will be recruited for this study. 
Teachers will be eligible if they are a lead teacher of an elementary classroom at a participating school. 
When recruiting teachers, we will make clear that participation does not require implementing active 
learning approaches. Rather, participation will entail completing baseline, 6-, and 12-month assessments 
along with implementation logs throughout the study. Teachers will receive a $40 gift card for 
completing assessments at each time point and implementation logs. A subsample of about 30 teachers 
and school staff (e.g., instructional coaches, administrators) will be recruited to participate in semi- 
structured individual or group interviews to further examine acceptability and their opinions about 
active learning during the first follow-up assessment. We will recruit another subsample of about 20 
teachers and school staff to participate in individual or group interviews to examine their perspectives of 
acceptability and active learning at the time of the second follow-up. For this second follow-up 
subsample, we will reconsent any teachers who participated in the first interview. We will use 
purposeful sampling by recruiting teachers from each grade (K-5) and school staff involved in supporting 
implementation efforts. Interview participants will receive a $30 gift card for interview participation. 
Students will be recruited from each school to examine student-level outcomes. All students will be 
eligible to participate unless they are unable to speak English or Spanish. For recruitment, study staff will 
conduct in-person presentations to students and staff to explain procedures and distribute recruitment 
materials. Each student will receive a permission packet consisting of a parent information sheet and a 
plain language consent form. The permission packet will be sent home with students and parents will be 
asked to sign the consent form and return it to the school if they agree to have their child participate in 
the study. After returning consent forms, study staff will obtain assent from students at school. We will 
use recruitment incentives (e.g., pencils for students, a project t-shirt for teachers) if 80% of students 
return their consent forms from a respective class. A subsample of 100 students at each school will be 
randomly selected to examine physical activity levels using a stratified sampling method based on grade 
and classroom. In addition, a subsample of about 30 students will also be recruited to participate in a 
semi-structured individual or group interview to examine the acceptability of active learning and learn 
more about physical activity from the student perspective. We will use a purposeful sampling method to 
recruit boys and girls, from grades (K-5). We will also work with teachers to help identify potential 
students across varying levels of engagement in active learning. Students who participate in an interview 
will receive a small toy of about $10 in value (e.g., a pop-it or fidget spinner). Students who choose not 
to participate will attend school/class as usual. There will be no data collection for these students and 
thus their information will not be used in the study. They will be able to participate in the classroom 
activities provided by the teachers, which may include physically active breaks, time in the motor lab, or 
other active learning activities. 
 
Study Procedures 
The study will consist of a baseline assessment and two follow-up assessments: 6-month and 12- 
months. There will be multiple forms of data collection including paper and pencil surveys for students, 
electronic surveys for teachers, implementation logs, direct observation, objective physical activity 

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assessment (using accelerometers), the use of existing district data, and qualitative interviews. Table 1 
provides an overview of variables, the method of assessment, and the collection time point. 
 
Table 1: Data Collection (B=Baseline; F/U= 6- & 12-Month Follow-ups) 
Variables 
Assessment Method 
Time 
Primary Study Outcomes 
Acceptability of Active Learning 
Teacher Surveys 
B and F/U 
Implementation Fidelity (dose) 
Teacher Survey and Implementation log 
B and F/U 
Student Physical Activity 
Accelerometers 
B and F/U 
Additional Study Outcomes 
Health Fitness Outcomes 
FitnessGram (collected by schools) 
F/U 
Academic Performance 
Test Scores (collected by schools) 
B and F/U 
Student Behavior 
Office referrals (collected by schools) 
B and F/U 
Implementation Fidelity 
(quality and adherence) 
Teacher Surveys and Classroom observations 
F/U 
Acceptability of 
implementation strategy 
Teacher interviews and surveys 
F/U 
Acceptability of active learning 
Student Questionnaires 
B and F/U 
Additional Variables 
Demographics 
Teacher Survey, Student data from district 
B 
CFIR and SCT constructs 
Teacher Survey 
B and F/U 
 
We will use Qualtrics (a secure data collection tool) to distribute the electronic survey link to 
teachers. School district data (FitnessGram, academic scores, student behavior, and student 
demographics) will be transferred using SecureStor, which is a cloud-based storage application that is 
approved for storage of HIPAA and FERPA information at UTHealth, and thus provides a secure method 
for data sharing. 
Qualitative data collection will consist of semi-structured individual or group interviews with 
teachers/staff and students beginning around the 6-month follow-up assessment. We will also conduct 
teacher/staff interviews at the 12-month follow-up assessment. Teacher/staff interviews will last 45-60 
minutes, while student interviews will last about 30 minutes. All interviews will be recorded and 
transcribed for analyses. We will conduct separate thematic content analyses for student and 
teacher/staff interviews using iterative and deductive codes.26-29 Two coders will independently review 
and open code interview transcripts to identify prominent themes related to acceptability and other 
topics discussed in interviews. 
Data collection for Primary Study Outcomes 
Acceptability is the perception that an intervention is agreeable, feasible, or satisfactory to 
intervention recipients and implementers.30 We will use the Acceptability of Implementation Measure 
(AIM)31, to examine acceptability of active learning among teachers. Data from the AIM will be collected 
as part of teacher surveys administered at baseline, 6- and 12-month follow-ups. 
Fidelity will serve as a primary implementation outcome. Fidelity is the degree to which an approach 
was implemented as prescribed and is typically measured in terms of adherence, dose of delivery, and 

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quality of delivery.30 Our primary fidelity outcome will be dose of delivery. We will use self-reported 
implementation logs and self-report surveys to assess dose.33 Implementation logs will be completed 
weekly throughout the study. 
Physical activity will serve as the effectiveness outcome to examine active learning at baseline, 6-, 
and 12-month follow-ups. We will use Actigraph GT3X+ accelerometers to examine minutes spent in 
moderate and vigorous physical activity. Accelerometers will be worn on an elastic belt placed above the 
iliac crest of the hip of each participant.34,35 Each belt will be attached to students within 30 minutes of 
the start of school and removed within 30 minutes of dismissal. Children will wear accelerometers for 5 
consecutive school days, which meets minimum reliability recommendations.36,37 Each school will have 
1-2 weeks of accelerometer data collection where we will assess 50-100 students/week. Research staff 
and trained parent volunteers will ensure accelerometers are properly placed and removed each day. 
Parent volunteers will receive a $10 gift card for each day they help with the study. 
Data Collection for Additional Study Outcomes (and additional variables) 
Health-related fitness variables will be used from the mandatory FitnessGram assessments. 
FitnessGram testing occurs annually and is completed for students in grades 3-5. We will use data 
collected during the study year and the previous year to serve as a baseline measure. We will examine 
body mass index (from height and weight measures), aerobic capacity (from the 20-m PACER test), 
muscular strength and endurance (from push-ups and curl ups tests), and flexibility (measured by a sit 
and reach test).38 Academic performance and student behavior will be additional outcomes given the 
district’s high level of interest. The district will share relevant academic and student behavior data. In 
addition, publicly available data from the Texas Education Agency will be used to examine academic 
trends for schools. 
Additional variables related to fidelity (i.e., quality and adherence) will also be assessed using the 
self-report survey and direct observation. Direct observation will be conducted by trained staff 
throughout the study. Staff will randomly select classrooms at different times of day to track 
implementation quality and adherence. Ratings will be based on: 1) how many children were active, 2) 
how often children were active, 3) the intensity of movement, and 4) adherence to core elements. We 
will also assess students’ acceptability of classroom-based approaches and teachers’ acceptability of the 
implementation strategy through survey questions and by conducting interviews. 
Additional Variables: We will collect student demographic information (e.g., sex, age, race, 
qualifying for free/reduced cost lunch) from school records and student’s self-reported physical activity 
data. We will also collect data from teachers (sex, age, race/ethnicity, number of years as a teacher, type 
of teacher, subject, physical activity level) and assess variables from implementation and health 
behavior theories and frameworks as part of the teacher survey. Examples of theoretical variables 
include culture, implementation climate, learning climate, leadership engagement, available resources, 
knowledge, skills, self-efficacy, attitudes, barriers, and outcome expectations. 
 
Data and Safety Monitoring 
Risks in this study are minimal but may include breaches of confidentiality and loss of time should 
participants not feel the study is relevant, although these are highly unlikely. The steps taken to reduce 
these risks include using UTHealth approved applications for sharing data and collecting consent (and 
assent from minors) prior to participation. We acknowledge that in addition to these risks, many 
unrelated and/or random adverse event may occur during the study period. All known related risks will 
be described in the consent form. 

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Dr. Walker is the PI and will be responsible for monitoring the safety environment of participants. 
Additional oversight will be provided by his mentors all of whom are experienced researchers. Dr. 
Walker will be responsible for monitoring procedures during the study for participants, including 
inclusion, enrollment, data collection, study outcomes, informed consent and assent in minors, and 
subject safety. 
 
Proposed monitoring and safety review: 
 
a) Immediate reporting of adverse events by team members to Dr. Walker 
b) Quarterly review of data by Dr. Walker and mentorship team during data collection phase 
Study data will be reviewed following each week of data collection during baseline and follow-up 
periods for each respective school by Dr. Walker. If an adverse event occurs, Dr. Walker and his mentors 
will determine whether the event requires reporting to the IRB, the school district’s Research and 
Develop office, and to NIH. 
 
 
Statistics 
Quantitative Analysis Strategy: We will use generalized linear models to compare implementation 
fidelity and acceptability between teachers who received the strategy versus teachers who did not. 
Longitudinal/ repeated measures analyses will be conducted for student level variables using 
generalized linear multilevel modeling. Multilevel effects will address classroom clustering. Bayesian 
approaches will implement joint modeling of observed outcomes and missing data, which is robust to 
ignorable missingness.39Sensitivity analyses will evaluate robustness of analytic conclusions to missing 
data. Convergence of Bayesian analyses on the posterior distributions via Monte-Carlo Markov chain will 
be assessed via graphical (Trace Plot, Autocorrelation Plot) and quantitative evidence (Gelman-Rubin 
Diagnostics and Effective Sample Size Diagnostics). Evaluation of posterior distributions will permit 
statements regarding the probability that effects of varying magnitudes exist, given the data. 
Specification of weak, neutral priors as well as the prior distribution for level two variances will follow 
recommendations by Gelman.40,41 The impact of the implementation strategy on implementation and 
student outcomes will be based on the posterior distribution of effect sizes. 
Sample Size: Given this is a feasibility study, the study purpose is to examine acceptability and 
effectiveness trends. Thus, the study is not designed to statistically examine school level differences in 
implementation outcomes. The study will provide important descriptive data and inform future work. 
Our analytic approach, applying Bayesian methods, will result in a posterior distribution for the credible 
effect size analysis, importantly providing both an index of the effect size and its associated uncertainty. 
This posterior distribution will permit probabilistic estimates of the alternative hypothesis. Moreover, 
subsequent trial planning will incorporate the entire posterior, both its estimate and associated 
uncertainty in developing a robust plan for a subsequent R01 study.42,43In addition, we will use the study 
information to calculate intraclass correlation coefficients at the teacher level to inform multilevel 
modeling in future studies. 
Exploratory Analysis: Because Action-Based Learning is relatively new and other types of physical 
activity have differentially appealed to boys and girls44,45, one important question is whether this 
approach is acceptable and effective for both sexes. Therefore, we will conduct an exploratory analysis 
examining acceptability and effectiveness trends between boys and girls. We will use approaches similar 

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to what have been previously described where gender will be entered into models as an additional 
interaction term. 
 
Ethics 
Teachers will be asked to complete a study consent prior to participation. The consent form will 
include information about completing an online survey, completing an implementation log, and agreeing 
to classroom observations. We will use a separate consent form for teachers/staff who are also 
interested in participating in an individual or group interview. We will provide teachers/staff with the 
option of participating in an in-person interview or a virtual interview using a program such as Webex or 
Microsoft teams. For teachers/staff who prefer to do a virtual interview, we will use a waiver of 
documentation of consent. 
We will obtain consent and assent for each student. Students will bring a permission packet 
home from school that will consist of a parent information sheet and a plain language consent form. 
After students return their consent form, study staff will obtain assent from students. The packets will 
be distributed to students’ families through weekly folders and other school-based events. 
 
Data handling and record keeping 
All collected data will be processed, analyzed, and stored on UTHealth School of Public Health’s 
dedicated secure server. Data will be recorded on UTSPH secure servers where only study staff will have 
password protected access to the study records. 
 
Surveys, implementation logs, and classroom observation data: Because some data from teachers will 
be collected through an electronic survey distributed through an email link, respondent information will 
be collected such as IP and email addresses. However, no other identifying or protected health 
information will be collected from electronic surveys. Hardcopies of data (e.g., student surveys, 
implementation logs, classroom observation forms, qualitative interview notes) will be stored in locked 
cabinets with limited key access. Each participant will receive a unique study identification number, 
which will be used to label data files. This study identification number will also be used to link study data 
from different sources. 
 
Interview data: All interviews will be recorded and transcribed. Transcriptions will be edited to exclude 
names and other identifying information. Audio and transcription files will be stored on UTHealth’s 
secure server. Demographic information (e.g., age and gender) will be collected from interview 
participants using a separate demographic questionnaire. This questionnaire will not include participant 
names and will only be use to describe the interview sample in aggregate form. 
 
Other Study Data and Information: Accelerometer data will be stored on UTHealth’s secure server for 
each student using a study identification number. Health fitness and academic performance data 
collected by the district will be shared using SecureStor, a cloud-based application that is approved for 
storage of HIPAA and FERPA information at UTHealth. In addition, other identifying information (e.g. 
consent forms, study identification linking file) will be stored in locked cabinets separate from study 
data. 
 
Data handling procedures will be overseen by Dr. Walker with the guidance of is mentoring committee. 

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Publication Plan 
We will use an approach informed by designing for dissemination (D4D) principles to communicate 
findings.46 D4D acknowledges that different audiences require specific messaging and communication 
channels.46-48 Thus, we will use our planning group to determine relevant findings for practitioners and 
identify dissemination opportunities. We will reach the community by writing 1-2-page briefs with 
infographics for district leaders and presenting at senior leader and staff meetings. We will reach 
Practitioners through local and national meetings (e.g. kinesthetic classroom collaborative, the American 
School Health Association Conference). We will also publish findings in practice-oriented journals. We 
will reach researchers in numerous fields (e.g. implementation science, physical activity) through 
publications in high-impact, peer-reviewed journals and research meetings such as the Dissemination 
and Implementation Conference. 
 
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