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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Implementation strategy for active learning to promote physical activity
Behavioral: 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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health fitness as assessed by FitnessGram (body mass index)
Time Frame: baseline
baseline
Health fitness as assessed by the FitnessGram (body mass index)
Time Frame: 6 months
6 months
Health fitness as assessed by the FitnessGram (body mass index)
Time Frame: 12 month follow up
12 month follow up
Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
Time Frame: baseline
baseline
Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
Time Frame: 6 month follow up
6 month follow up
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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