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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05048433
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
1,185
1
2
17
69.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: implementation strategy for active learning to promote physical activity
  • Behavioral: Usual Implementation support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1185 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability of the implementation strategy and active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM) [Baseline]

    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.

  2. Acceptability of the implementation strategy and active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM) [6 months follow up]

    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.

  3. Acceptability of the implementation strategy and active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM) [12 months follow up]

    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.

  4. Acceptability of active learning among students as assessed by the Acceptability of Implementation Measure (AIM) [Baseline]

    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.

  5. Acceptability of active learning among students as assessed by the Acceptability of Implementation Measure (AIM) [6 months follow up]

    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. Acceptability of active learning among students as assessed by the Acceptability of Implementation Measure (AIM) [12 months follow up]

    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.

  7. Implementation Fidelity as assessed by self-reported implementation logs to assess dose of delivery [6 months]

    Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per week of active learning used.

  8. Implementation Fidelity as assessed by self-reported implementation logs to assess dose of delivery [12 months]

    Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per week of active learning used.

  9. Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer [baseline]

  10. 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]

  11. 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 Outcome Measures

  1. Health fitness as assessed by FitnessGram (body mass index) [baseline]

  2. Health fitness as assessed by the FitnessGram (body mass index) [6 months]

  3. Health fitness as assessed by the FitnessGram (body mass index) [12 month follow up]

  4. Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard [baseline]

  5. Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard [6 month follow up]

  6. Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard [12 month follow up]

  7. Academic Performance as assessed by Test scores [Baseline]

    Score ranges from 0 to 100, with a higher score indicating a better outcome.

  8. Academic Performance as assessed by Test scores [6 month follow up]

    Score ranges from 0 to 100, with a higher score indicating a better outcome.

  9. Academic Performance as assessed by Test scores [12 month follow up]

    Score ranges from 0 to 100, with a higher score indicating a better outcome.

  10. Implementation Fidelity as assessed by direct observation to assess quality [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.

  11. Implementation Fidelity as assessed by direct observation to assess quality [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. Implementation Fidelity as assessed by direct observation to assess adherence [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.

  13. Implementation Fidelity as assessed by direct observation to assess adherence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • lead teachers that teach kindergarten to fifth grade

  • children in kindergarten to fifth grade

Exclusion Criteria:
  • non English or Spanish speaking

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Timothy J Walker, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Timothy J Walker, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05048433
Other Study ID Numbers:
  • HSC-SPH-20-0861
  • K01HL151817
First Posted:
Sep 17, 2021
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Timothy J Walker, Assistant Professor, The University of Texas Health Science Center, Houston

Study Results

No Results Posted as of Jun 21, 2022