Evaluating an Implementation Strategy to Improve Physical Activity and Reduce Cardiovascular Risk Factors in Children
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Timothy Walker, PhD
- Phone Number: (713) 500 9664
- Email: Timothy.J.Walker@uth.tmc.edu
Study Contact Backup
- Name: Matthew Lee
- Phone Number: (713) 500-9000
- Email: Matthew.Lee@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77479
- The University of Texas Health Science Center at Houston
-
Contact:
- Matthew Lee
- Phone Number: (713) 500-9000
- Email: Matthew.Lee@uth.tmc.edu
-
Contact:
- Timothy Walker, PhD
- Phone Number: 713-500-9664
- Email: Timothy.J.Walker@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- students enrolled at participating elementary schools at the partner district
- teachers employed at participating elementary schools at the partner district
Exclusion Criteria:
- non English or Spanish speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Control
|
Participants may receive usual support from the district with access to guidance from district leaders
|
|
Experimental: MAGIC
|
The experimental arm includes using a multifaceted implementation strategy to support the use of classroom-based physical activity approaches (e.g., physically active breaks, physically active lessons, and motor labs).
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Implementation fidelity as assessed by teacher self-reported implementation logs to assess dose of delivery
Time Frame: Baseline
|
Baseline
|
|
Implementation fidelity as assessed by teacher self-reported implementation logs to assess dose of delivery
Time Frame: about 6 months after baseline
|
about 6 months after baseline
|
|
Implementation fidelity as assessed by teacher self-reported implementation logs to assess dose of delivery
Time Frame: about 12 months after baseline
|
about 12 months after baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate to Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer
Time Frame: baseline
|
This outcome measure will be reported as total number of minutes of moderate to vigorous physical activity
|
baseline
|
|
Student Physical Activity as Indicated by Number of Minutes Per Day Spent in Moderate to Vigorous Physical Activity as Assessed by the Actigraph GT3X+ Accelerometer
Time Frame: about 6 months after baseline
|
This outcome measure will be reported as total number of minutes of moderate to vigorous physical activity
|
about 6 months after baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Timothy Walker, PhD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HSC-SPH-25-0498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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