Physical ActivityNCT05048433

Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children

A study testing Implementation strategy for active learning to promote physical activity and Usual implementation support in people with Physical Activity, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for: Physical Activity
What is being tested?: Implementation strategy for active learning to promote physical activity and Usual implementation support
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2023to 22 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

lead teachers who teach kindergarten to fifth grade
children in kindergarten to fifth grade

Who cannot join

non English or Spanish speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Physical Activity
Being tested: Implementation strategy for active learning to promote physical activity, Usual implementation support
Keywords: Implementation of Physical Activity Programs in Schools
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implementation strategy for active learning to promote physical activityBehavioural
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.
Usual implementation supportBehavioural
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.

Study groups in NCT05048433
Study group	Role	What they receive
Implementation strategy for active learning to promote physical activity	Experimental	Not described Receives: Behavioral: Implementation strategy for active learning to promote physical activity
Usual implementation support	Active comparator	Not described Receives: Behavioral: Usual implementation support

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)
The Acceptability of Implementation Measure (AIM) total score is from 1 to 5, with higher scores representing higher levels of acceptability.
Measured: Baseline
Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)
The Acceptability of Implementation Measure (AIM) total score is from 1 to 5, with higher scores representing higher levels of acceptability.
Measured: Approximately 7 months after baseline
Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)
The Acceptability of Implementation Measure (AIM) total score is from 1 to 5, with higher scores representing higher levels of acceptability.
Measured: Approximately 13 months after baseline
Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery
Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per day of active learning used.
Measured: Baseline
Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery
Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per week of active learning used.
Measured: Approximately 7 months after baseline
Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery
Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per day of active learning used.
Measured: Approximately 13 months after baseline
Implementation Fidelity as Assessed by Teacher Survey of Dose of Delivery
Dose of delivery is the number of minutes per day of active learning used.
Measured: Baseline
Implementation Fidelity as Assessed by Teacher Survey of Dose of Delivery
Dose of delivery is the number of minutes per day of active learning used.
Measured: Approximately 7 months after baseline
Implementation Fidelity as Assessed by Teacher Survey of Dose of Delivery
Dose of delivery is the number of minutes per day of active learning used.
Measured: 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
Measured: 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
Measured: 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
Measured: Approximately 13 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202322 Nov 2024

First posted17 Sep 2021
Study start4 Aug 2023
Primary completion22 Nov 2024
Study completion22 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05048433
Sponsor's protocol ID: HSC-SPH-20-0861
Other IDs: K01HL151817
Status last verified: Dec 2025
First submitted: 8 Sep 2021
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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;26(1):36. doi: 10.1186/s12889-025-25333-0.
PubMed 41310531
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.
PubMed 35256018

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
ClinicalTrials.gov ID: NCT05048433
Acronym / sponsor ID: HSC-SPH-20-0861
Conditions: Physical Activity
Keywords: Implementation of Physical Activity Programs in Schools
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 4 Aug 2023 (actual)
Primary completion: 22 Nov 2024 (actual)
Study completion: 22 Nov 2024 (actual)
First posted: 17 Sep 2021 (actual)
Results: Posted 14 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Implementation strategy for active learning to promote physical activity	Experimental	Behavioral: Implementation strategy for active learning to promote physical activity
Usual implementation support	Active comparator	Behavioral: Usual implementation support

Who may qualify

Ages: 5 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

lead teachers who teach kindergarten to fifth grade
children in kindergarten to fifth grade

Key exclusion criteria (1 listed)

non English or Spanish speaking

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implementation strategy for active learning to promote physical activityThe 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.	Behavioural	Implementation strategy for active learning to promote physical activity
Usual implementation supportUsual 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.	Behavioural	Usual implementation support

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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

Results and safety

Results posted to the registry on 14 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implementation Strategy for Active Learning to Promote Physical Activity	136	136
Usual Implementation Support	133	133

Primary outcome: Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Implementation Strategy for Active Learning to Promote Physical Activity n = 29	Usual Implementation Support n = 27
Value	4.7 (0.4)	4.3 (1)

Population analysed: Data were only collected from Teacher Participants who completed the survey.

Primary outcome: Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)

Time frame: Approximately 7 months after baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Implementation Strategy for Active Learning to Promote Physical Activity n = 30	Usual Implementation Support n = 26
Value	4.6 (0.7)	4.5 (0.9)

Population analysed: Data were only collected from Teacher Participants who completed the survey.

Primary outcome: Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)

Time frame: Approximately 13 months after baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Implementation Strategy for Active Learning to Promote Physical Activity n = 24	Usual Implementation Support n = 19
Value	4.7 (0.4)	4.8 (0.4)

Population analysed: Data were only collected from Teacher Participants who completed the survey.

Primary outcome: Implementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery

Time frame: Baseline. Mean (Standard Deviation). Unit: minutes per day

Measure	Implementation Strategy for Active Learning to Promote Physical Activity n = 21	Usual Implementation Support n = 23
Value	6.5 (8.8)	6.8 (16.7)

Population analysed: Data were only collected from Teacher Participants who completed the self-reported implementation log.

Adverse events

Time frame: From Fall 2023 to Fall 2024 (About 15 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implementation Strategy for Active Learning to Promote Physical Activity: Children	0 of 124 (0%)	0 of 124 (0%)	0 of 124
Usual Implementation Support: Children	0 of 104 (0%)	0 of 104 (0%)	0 of 104
Implementation Strategy for Active Learning to Promote Physical Activity: Teachers	0 of 35 (0%)	0 of 38 (0%)	0 of 35
Usual Implementation Support: Teachers	0 of 38 (0%)	0 of 35 (0%)	0 of 38

Limitations and caveats (from the sponsor): The reported implementation and physical activity outcomes are unadjusted values.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41310531Walker 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;26(1):36. doi: 10.1186/s12889-025-25333-0.
Derived from this study: PubMed 35256018Walker 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.
Individual participant dataSharing planned: No

Related trials for Physical Activity

Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
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Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy J Walker, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05048433, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.