- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05048433
Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
December 19, 2025 updated by: Timothy J Walker, The University of Texas Health Science Center, Houston
The purpose of this study is to develop an implementation strategy to improve the use and sustainment of active learning in elementary schools and to conduct a feasibility study to evaluate the impact of the developed implementation strategy on the implementation and effectiveness of active learning.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
301
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- lead teachers who teach kindergarten to fifth grade
- children in kindergarten to fifth grade
Exclusion Criteria:
- non English or Spanish speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Implementation strategy for active learning to promote physical activity
|
The experimental arm includes using a multifaceted implementation strategy to support the use of classroom-based physical activity approaches.
The strategy consists of a series of leadership trainings designed to help them support teachers, teacher trainings to build skills, and a monthly newsletter to reinforce implementation and provide access to existing resources.
|
|
Active Comparator: Usual implementation support
|
Usual support consists of the potential to access general resources from the district wellness department.
These resources include access to funds to send staff to external trainings and general guidance for how to use active learning approaches.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)
Time Frame: Baseline
|
The Acceptability of Implementation Measure (AIM) total score is from 1 to 5, with higher scores representing higher levels of acceptability.
|
Baseline
|
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Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)
Time Frame: Approximately 7 months after baseline
|
The Acceptability of Implementation Measure (AIM) total score is from 1 to 5, with higher scores representing higher levels of acceptability.
|
Approximately 7 months after baseline
|
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Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)
Time Frame: Approximately 13 months after baseline
|
The Acceptability of Implementation Measure (AIM) total score is from 1 to 5, with higher scores representing higher levels of acceptability.
|
Approximately 13 months after baseline
|
|
Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery
Time Frame: Baseline
|
Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per day of active learning used.
|
Baseline
|
|
Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery
Time Frame: Approximately 7 months after baseline
|
Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per week of active learning used.
|
Approximately 7 months after baseline
|
|
Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery
Time Frame: Approximately 13 months after baseline
|
Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per day of active learning used.
|
Approximately 13 months after baseline
|
|
Implementation Fidelity as Assessed by Teacher Survey of Dose of Delivery
Time Frame: Baseline
|
Dose of delivery is the number of minutes per day of active learning used.
|
Baseline
|
|
Implementation Fidelity as Assessed by Teacher Survey of Dose of Delivery
Time Frame: Approximately 7 months after baseline
|
Dose of delivery is the number of minutes per day of active learning used.
|
Approximately 7 months after baseline
|
|
Implementation Fidelity as Assessed by Teacher Survey of Dose of Delivery
Time Frame: Approximately 13 months after baseline
|
Dose of delivery is the number of minutes per day of active learning used.
|
Approximately 13 months after baseline
|
|
Student Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer
Time Frame: Baseline
|
Baseline
|
|
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Student Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer
Time Frame: Approximately 7 months after baseline
|
Approximately 7 months after baseline
|
|
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Student Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer
Time Frame: Approximately 13 months after baseline
|
Approximately 13 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health fitness as assessed by FitnessGram (body mass index)
Time Frame: baseline
|
baseline
|
|
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Health fitness as assessed by the FitnessGram (body mass index)
Time Frame: 6 months
|
6 months
|
|
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Health fitness as assessed by the FitnessGram (body mass index)
Time Frame: 12 month follow up
|
12 month follow up
|
|
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Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
Time Frame: baseline
|
baseline
|
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Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
Time Frame: 6 month follow up
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6 month follow up
|
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Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
Time Frame: 12 month follow up
|
12 month follow up
|
|
|
Academic Performance as assessed by Test scores
Time Frame: Baseline
|
Score ranges from 0 to 100, with a higher score indicating a better outcome.
|
Baseline
|
|
Academic Performance as assessed by Test scores
Time Frame: 6 month follow up
|
Score ranges from 0 to 100, with a higher score indicating a better outcome.
|
6 month follow up
|
|
Academic Performance as assessed by Test scores
Time Frame: 12 month follow up
|
Score ranges from 0 to 100, with a higher score indicating a better outcome.
|
12 month follow up
|
|
Implementation Fidelity as assessed by direct observation to assess adherence
Time Frame: 6 month follow up
|
Direct observation will be conducted by trained staff throughout the study.Fidelity adherence is indicated by the percentage of occurrence of teacher-directed active learning during an observation period.
This is determined by the total number of intervals of teacher directed classroom movement activities relative to the total number of intervals of observation.
A higher percentage indicates a greater adherence to active learning.
|
6 month follow up
|
|
Implementation Fidelity as assessed by direct observation to assess quality
Time Frame: 6 month follow up
|
Direct observation will be conducted by trained staff throughout the study.
Fidelity quality is indicated based on the student response.
This is determined by the approximate percent of students in the class who are participating in active learning averaged across the active learning sessions used.
A higher percentage of student participation indicates a higher quality of active learning delivery.
|
6 month follow up
|
|
Implementation Fidelity as assessed by direct observation to assess quality
Time Frame: 12 month follow up
|
Direct observation will be conducted by trained staff throughout the study.
Fidelity quality is indicated based on the student response.
This is determined by the approximate percent of students in the class who are participating in active learning averaged across the active learning sessions used.
A higher percentage of student participation indicates a higher quality of active learning delivery.
|
12 month follow up
|
|
Implementation Fidelity as assessed by direct observation to assess adherence
Time Frame: 12 month follow up
|
Direct observation will be conducted by trained staff throughout the study.
Fidelity adherence is indicated by the percentage of occurrence of teacher-directed active learning during an observation period.
This is determined by the total number of intervals of teacher directed classroom movement activities relative to the total number of intervals of observation.
A higher percentage indicates a greater adherence to active learning.
|
12 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Timothy J Walker, PhD, The University of Texas Health Science Center, Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Walker TJ, Kohl HW 3rd, Bartholomew JB, Green C, Fernandez ME. Using Implementation Mapping to develop and test an implementation strategy for active learning to promote physical activity in children: a feasibility study using a hybrid type 2 design. Implement Sci Commun. 2022 Mar 7;3(1):26. doi: 10.1186/s43058-022-00271-9.
- Walker TJ, Craig DW, Pfledderer CD, Lee M, Onadeko K, Saving EE, Bartholomew JB, Fernandez ME. Feasibility and acceptability of an implementation strategy to enhance use of classroom-based physical activity approaches in elementary schools: a mixed methods study. BMC Public Health. 2025 Nov 27. doi: 10.1186/s12889-025-25333-0. Online ahead of print.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2023
Primary Completion (Actual)
November 22, 2024
Study Completion (Actual)
November 22, 2024
Study Registration Dates
First Submitted
September 8, 2021
First Submitted That Met QC Criteria
September 8, 2021
First Posted (Actual)
September 17, 2021
Study Record Updates
Last Update Posted (Estimated)
January 14, 2026
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SPH-20-0861
- K01HL151817 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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