Stay Active Physical Activity Program

June 11, 2021 updated by: Children's Mercy Hospital Kansas City

Stay Active Physical Activity Program for Teachers, Students, and Families

The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.

Study Overview

Detailed Description

This study will compare the impact of two physical activity interventions on student's physical activity.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Classrooms

  • Teacher of a 4th or 5th grade class in the Kansas City area.
  • English speaking only

Students

  • Any student in the selected classrooms
  • A parent or guardian of the student
  • English speaking only

Exclusion Criteria:

  • Does not meet the required criteria above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Classroom Intervention

Physical activity support is provided by integrating daily structured activities in the classroom delivered by physical activity leaders through a video conferencing platform in partnership with the classroom teacher. Activities last about 10 minutes or less and have the flexibility of being integrated with academic lessons or serving as a break from academics.

The activities are simple and get kids moving in place. The activities will be delivered by a research staff member via video conferencing (using the schools preferred platform). A combination of live activities led by the research team and pre-recorded videos will be used (see example below). If live videos do not work for the teacher, they will have the option to only use the pre-recorded videos or receive a list of resources to promote CBPA in their classrooms.

Classroom Based Physical Activity
Experimental: Classroom Intervention plus family support

Same components as the Classroom Intervention Arm plus the following:

Family Component: A newsletter will be sent to parents or guardians once every two weeks over the semester and posted on the study website. The newsletters include physical activity information related to safety/protection, skills building, motivation, overcoming barriers, and goal setting and monitoring (all newsletters are included as an appendix). As part of the program, children also receive a Garmin wearable physical activity monitor. Parents or guardians will receive text messages with behavior change messages based on the Garmin data (text message content is included as an appendix). Text messages also contain links to website materials.

Texts will be sent out using the Twilio platform.

Classroom Based Physical Activity + family support as described in the Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily minutes of PA (physical activity)
Time Frame: 3 months
Measured by Garmin device
3 months
Daily step count
Time Frame: 3 months
Measured by Garmin device
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent perceptions of interventions
Time Frame: 3 months
Measured via satisfaction surveys
3 months
Teacher perceptions of interventions
Time Frame: 3 months
Measured via satisfaction interviews
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jordan Carlson, PhD, Research Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

December 20, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00001495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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