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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05048433
Enrollment
301
Registered
2021-09-17
Start date
2023-08-04
Completion date
2024-11-22
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

Implementation of Physical Activity Programs in Schools

Brief 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.

Interventions

BEHAVIORALImplementation 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.

BEHAVIORALUsual 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.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* non English or Spanish speaking

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)BaselineThe 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 DeliveryBaselineImplementation 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 DeliveryBaselineDose 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+ AccelerometerBaseline

Countries

United States

Participant flow

Participants by arm

ArmCount
Implementation Strategy for Active Learning to Promote Physical Activity
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.
159
Usual Implementation Support
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.
142
Total301

Baseline characteristics

CharacteristicImplementation Strategy for Active Learning to Promote Physical ActivityTotalUsual Implementation Support
Age, Continuous
Children
7.6 years
STANDARD_DEVIATION 1.4
7.5 years
STANDARD_DEVIATION 1.5
7.3 years
STANDARD_DEVIATION 1.5
Age, Continuous
Teachers
35.4 years
STANDARD_DEVIATION 11
38.5 years
STANDARD_DEVIATION 12.1
41.9 years
STANDARD_DEVIATION 12.6
Ethnicity (NIH/OMB)
Children
Hispanic or Latino
71 Participants143 Participants72 Participants
Ethnicity (NIH/OMB)
Children
Not Hispanic or Latino
52 Participants83 Participants31 Participants
Ethnicity (NIH/OMB)
Children
Unknown or Not Reported
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Teachers
Hispanic or Latino
8 Participants22 Participants14 Participants
Ethnicity (NIH/OMB)
Teachers
Not Hispanic or Latino
27 Participants45 Participants18 Participants
Ethnicity (NIH/OMB)
Teachers
Unknown or Not Reported
0 Participants6 Participants6 Participants
Race (NIH/OMB)
Children
American Indian or Alaska Native
17 Participants40 Participants23 Participants
Race (NIH/OMB)
Children
Asian
1 Participants4 Participants3 Participants
Race (NIH/OMB)
Children
Black or African American
41 Participants71 Participants30 Participants
Race (NIH/OMB)
Children
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Children
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Children
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Children
White
63 Participants109 Participants46 Participants
Race (NIH/OMB)
Teachers
American Indian or Alaska Native
1 Participants4 Participants3 Participants
Race (NIH/OMB)
Teachers
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Teachers
Black or African American
21 Participants33 Participants12 Participants
Race (NIH/OMB)
Teachers
More than one race
1 Participants5 Participants4 Participants
Race (NIH/OMB)
Teachers
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Teachers
Unknown or Not Reported
0 Participants6 Participants6 Participants
Race (NIH/OMB)
Teachers
White
12 Participants24 Participants12 Participants
Region of Enrollment
United States
159 participants301 participants142 participants
Sex: Female, Male
Children
Female
57 Participants111 Participants54 Participants
Sex: Female, Male
Children
Male
66 Participants115 Participants49 Participants
Sex: Female, Male
Teachers
Female
31 Participants54 Participants23 Participants
Sex: Female, Male
Teachers
Male
4 Participants13 Participants9 Participants
Student's Lunch Status
Free
93 Participants178 Participants85 Participants
Student's Lunch Status
Non-participant
9 Participants18 Participants9 Participants
Student's Lunch Status
Reduced Lunch
21 Participants30 Participants9 Participants
Student's Lunch Status
Unknown or Not Reported
1 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1240 / 1040 / 350 / 38
other
Total, other adverse events
0 / 1240 / 1040 / 380 / 35
serious
Total, serious adverse events
0 / 1240 / 1040 / 350 / 38

Outcome results

Primary

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.

Time frame: Approximately 13 months after baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityAcceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)4.7 score on a scaleStandard Deviation 0.4
Usual Implementation SupportAcceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)4.8 score on a scaleStandard Deviation 0.4
Primary

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.

Time frame: Baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityAcceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)4.7 score on a scaleStandard Deviation 0.4
Usual Implementation SupportAcceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)4.3 score on a scaleStandard Deviation 1
Primary

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.

Time frame: Approximately 7 months after baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityAcceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)4.6 score on a scaleStandard Deviation 0.7
Usual Implementation SupportAcceptability of Active Learning Among Teachers as Assessed by the Acceptability of Implementation Measure (AIM)4.5 score on a scaleStandard Deviation 0.9
Primary

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.

Time frame: Approximately 13 months after baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityImplementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery9.3 minutes per dayStandard Deviation 19.5
Usual Implementation SupportImplementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery9.7 minutes per dayStandard Deviation 9.7
Primary

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.

Time frame: Baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityImplementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery6.5 minutes per dayStandard Deviation 8.8
Usual Implementation SupportImplementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery6.8 minutes per dayStandard Deviation 16.7
Primary

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.

Time frame: Approximately 7 months after baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityImplementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery13.5 minutes per dayStandard Deviation 17.2
Usual Implementation SupportImplementation Fidelity as Assessed by Self-reported Implementation Logs to Assess Dose of Delivery12.9 minutes per dayStandard Deviation 16.8
Primary

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.

Time frame: Approximately 7 months after baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityImplementation Fidelity as Assessed by Teacher Survey of Dose of Delivery16 minutes per dayStandard Deviation 10.9
Usual Implementation SupportImplementation Fidelity as Assessed by Teacher Survey of Dose of Delivery12.8 minutes per dayStandard Deviation 12.6
Primary

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.

Time frame: Approximately 13 months after baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityImplementation Fidelity as Assessed by Teacher Survey of Dose of Delivery14.5 minutes per dayStandard Deviation 11.8
Usual Implementation SupportImplementation Fidelity as Assessed by Teacher Survey of Dose of Delivery14.3 minutes per dayStandard Deviation 12.7
Primary

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.

Time frame: Baseline

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

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityImplementation Fidelity as Assessed by Teacher Survey of Dose of Delivery11.8 minutes per dayStandard Deviation 10.5
Usual Implementation SupportImplementation Fidelity as Assessed by Teacher Survey of Dose of Delivery8.3 minutes per dayStandard Deviation 9.1
Primary

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

Population: Data were collected only from participants who wore the ActiGraph GT3X+ accelerometer for sufficient time to meet valid wear-time criteria.

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityStudent Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer22.7 minutes per dayStandard Deviation 8.2
Usual Implementation SupportStudent Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer26.2 minutes per dayStandard Deviation 8.7
Primary

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

Population: Data were collected only from participants who wore the ActiGraph GT3X+ accelerometer for sufficient time to meet valid wear-time criteria.

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityStudent Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer26.5 minutes per dayStandard Deviation 11.1
Usual Implementation SupportStudent Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer25.1 minutes per dayStandard Deviation 8.9
Primary

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

Population: Data were collected only from participants who wore the ActiGraph GT3X+ accelerometer for sufficient time to meet valid wear-time criteria.

ArmMeasureValue (MEAN)Dispersion
Implementation Strategy for Active Learning to Promote Physical ActivityStudent Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer25.2 minutes per dayStandard Deviation 10.3
Usual Implementation SupportStudent Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate and Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer26.7 minutes per dayStandard Deviation 9.8

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026