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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03493139
Other study ID # STUDY00141841
Secondary ID R01DK085317
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date August 1, 2023

Study information

Verified date September 2020
Source University of Kansas Medical Center
Contact Joseph Donnelly, PhD
Phone (785) 864-1687
Email jdonnelly2@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is designed to compare two methods of delivering short (~10 min) physical activity breaks that will occur during the regular school day for 3 years. Schools will be randomized to deliver physical activity breaks led by either the regular classroom teacher or by a remote instructor through a video in the classroom. Both delivery methods will promote a variety of whole body movements using large muscle groups. The schools will not be able to choose which group (regular teacher or remote instructor) they will be part of.


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date August 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria:

- 2nd and 3rd grade students

Exclusion Criteria:

- Students who are confined to a wheel chair, blind, or intellectually disadvantaged may be unable perform tests for cardiovascular fitness or MVPA using accelerometers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity Across the Curriculum
Activity breaks will be designed for delivery in the classroom without reconfiguration of the classroom space. Activities will emphasize whole body movements, using large muscle groups. Each break includes multiple activities. Each activity lasts about 2 minutes. There will be a total of about 20 minutes of physical activity done each school day.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Moderate-to-vigorous physical activity (MVPA) time during activity breaks Measure will be calculated as the average number of minutes of moderate to vigorous physical activity (MVPA) during the period of activity breaks. Measure will be captured using an accelerometer. Year 3
Secondary MVPA time during the school day Measure will be calculated as the average number of minutes of moderate to vigorous physical activity (MVPA) during the school day. Measure will be captured using an accelerometer. Year 3
Secondary Total daily MVPA Measure will be calculated as the average number of minutes of moderate to vigorous physical activity (MVPA) during the entire day. Measure will be captured using an accelerometer. Year 3
Secondary Body mass index (BMI) Weight and height will be combined to report BMI in kg/m^2. Fall Semester Year 1
Secondary Body mass index (BMI) Weight and height will be combined to report BMI in kg/m^2. Spring Semester Year 1
Secondary Body mass index (BMI) Weight and height will be combined to report BMI in kg/m^2. Spring Semester Year 2
Secondary Body mass index (BMI) Weight and height will be combined to report BMI in kg/m^2. Spring Semester Year 3
Secondary Energy expenditure of activity breaks Calculated as the number of calories used during a classroom activity break. Year 2
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