- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05744791
Active Play Intervention for Preschoolers (Active Play)
The Influence of a Planned Movement and Physical Activity Program on the Physiological and Psychology Parameters in a Pediatric Population
The goal of this randomized clinical trial is to examine the effects of a planned movement in preschool-aged children. The main question is to determine
* What are the effects of a planned movement program on physical activity, body composition, fundamental motor skills, and time on task in preschool children aged 3-5 years?
Researchers will compare a planned movement program to a control group, where current instruction is implemented.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Auburn University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 3 to 5 years of age
- attending one of the preschools 5 days a week.
Exclusion Criteria:
- less than 3 years of age
- greater than 5 years of age at the beginning of the study
- attends the preschool 2 days or 3 days a week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Preschool teachers will continue to implement their regular curriculum.
This consists of one outdoor play opportunity for 30 minutes each day.
|
|
|
Experimental: Active Play Intervention
Preschool teachers will be asked to implement two active play activities each preschool day, one indoors and one outdoors.
This is in addition to the current outdoor free play of 30 minutes each day.
Each activity is 10-15 minutes for a total of 20-30 minutes per day.
|
Teachers will implement an addition two physical activity opportunities that incorporate active play each day for a potential dose of 20-30 minutes per day and 100-150 minutes per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: 12 weeks
|
An accelerometer attached at the wrist will measure physical activity over 24 hours for 5 days at baseline and 12 weeks
|
12 weeks
|
|
Body composition
Time Frame: 12 weeks
|
Percent body fat, ratio of fat mass to lean mass, will be assessed with electrical impedance.
|
12 weeks
|
|
Time on Task
Time Frame: 12 weeks
|
The percentage of time spent on task will be observed and presented as a ratio of time on task to time spent off task.
|
12 weeks
|
|
Fundamental motor skills
Time Frame: 12 weeks
|
The fundamental motor skill gross quotient will be measured with the Peabody Developmental Motor Scales, Second Edition 2nd edition (PDMS-2).
The sum of points comprises the raw scores for each subscale.
Raw scores range for each subscale are 6-60 for Stationary Skills, 6-178 for Locomotion Skills, and 6-48 for Object Manipulation Skills.
Using age-appropriate tables in the testing manual, we will convert the raw scores to standardized scores (0-20) and summed them to determine the gross motor quartile (GMQ), which has a range of 41 - 164.
A higher score indicates a more favorable outcome.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10-217 MR 1009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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