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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048433
• Other study ID #: HSC-SPH-20-0861
• Secondary ID: K01HL151817
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Timothy J Walker, PhD
• Phone: (713) 500-9664
• Email: Timothy.J.Walker[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1185
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• lead teachers that teach kindergarten to fifth grade

• children in kindergarten to fifth grade

Exclusion Criteria:

• non English or Spanish speaking

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• implementation strategy for active learning to promote physical activity
The experimental arm includes using a multifaceted implementation strategy to support the use of active learning approaches. The strategy will consist of a series of skills-based staff trainings, identifying program champions to help lead efforts within the school, establishing an audit and feedback system to monitor the use of active learning, and a reinforcement system to recognize staff who are successfully implementing.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the implementation strategy and active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)	The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.	Baseline
Primary	Acceptability of the implementation strategy and active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)	The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.	6 months follow up
Primary	Acceptability of the implementation strategy and active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)	The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.	12 months follow up
Primary	Acceptability of active learning among students as assessed by the Acceptability of Implementation Measure (AIM)	The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.	Baseline
Primary	Acceptability of active learning among students as assessed by the Acceptability of Implementation Measure (AIM)	The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.	6 months follow up
Primary	Acceptability of active learning among students as assessed by the Acceptability of Implementation Measure (AIM)	The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.	12 months follow up
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.	6 months
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.	12 months
Primary	Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer		baseline
Primary	Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer		6 month follow up
Primary	Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer		12 month follow up
Secondary	Health fitness as assessed by FitnessGram (body mass index)		baseline
Secondary	Health fitness as assessed by the FitnessGram (body mass index)		6 months
Secondary	Health fitness as assessed by the FitnessGram (body mass index)		12 month follow up
Secondary	Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard		baseline
Secondary	Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard		6 month follow up
Secondary	Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard		12 month follow up
Secondary	Academic Performance as assessed by Test scores	Score ranges from 0 to 100, with a higher score indicating a better outcome.	Baseline
Secondary	Academic Performance as assessed by Test scores	Score ranges from 0 to 100, with a higher score indicating a better outcome.	6 month follow up
Secondary	Academic Performance as assessed by Test scores	Score ranges from 0 to 100, with a higher score indicating a better outcome.	12 month follow up
Secondary	Implementation Fidelity as assessed by direct observation to assess quality	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
Secondary	Implementation Fidelity as assessed by direct observation to assess quality	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
Secondary	Implementation Fidelity as assessed by direct observation to assess adherence	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
Secondary	Implementation Fidelity as assessed by direct observation to assess adherence	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