- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588392
Short bouTs of Exercise for Preschool-age Children (STEP)
June 7, 2023 updated by: Sofiya Alhassan, University of Massachusetts, Amherst
Effects of Short Bouts of Physical Activity in Low-income Preschool-age Children
The purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Most preschool centers provide two 30-minute sessions of gross-motor/outdoor playtime per preschool day.
Within this time frame, children accumulate most of their activity within the first 10 minutes.
This study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity in preschoolers.
Results from this intervention could provide evidence that a physical activity policy that exposes preschoolers to shorter bouts of structured physical activity throughout the preschool day could potentially increase preschooler's physical activity levels.
Study Type
Interventional
Enrollment (Actual)
323
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
-
-
Massachusetts
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Springfield, Massachusetts, United States, 01103
- Preschool centers in Springfield, MA
-
-
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
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Attend one of 10 participating preschool centers
- Attend preschool full-time
- Children between 2.9 - 5 years of age on the date of baseline assessment
Exclusion Criteria:
- Did not have a condition limiting their participation in routine gross-motor playtime at preschool
- Unable to wear the activity monitor
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Short bouts of structured activity
|
Short bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities.
Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months.
Other Names:
|
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Active Comparator: Unstructured physical activity
|
Unstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice.
intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Physical activity levels at 6-month
Time Frame: Baseline, 3-month and 6-month after study initiation
|
Physical activity levels will be assessed with accelerometer and direct observation system
|
Baseline, 3-month and 6-month after study initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sofiya Alhassan, University of Massachusetts, Amherst
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
April 25, 2012
First Submitted That Met QC Criteria
April 26, 2012
First Posted (Estimated)
May 1, 2012
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010-0817
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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