Active Play Intervention for Preschoolers

Exercise Clinical Trial

— Active Play  

Official title:

The Influence of a Planned Movement and Physical Activity Program on the Physiological and Psychology Parameters in a Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05744791
• Other study ID #: 10-217 MR 1009
• Status: Completed
• Phase: N/A
• Start date: August 14, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2023
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

A majority of preschool children do not participate in the recommended levels of physical activity and are deficient in fundamental motor skills. These deficits may also impact body composition. Preschool teachers serve as the gateway to providing physical activity opportunities at preschool but many fail to do so. As play is developmentally appropriate for preschools and part of many curriculums adding active elements to play may be a feasible solution for teachers to implement physical activity opportunities. This project will evaluate the effect of a planned movement program that incorporates elements of active play on preschoolers' body composition, physical activity, time on task, and fundamental motor skills at week 0, week 12, and week 24. Physical Activity will be assessed throughout the school year with a wrist-worn wearable accelerometer. Body composition will be assessed with a foot-to-foot bioelectrical impedance scale. Fundamental motor skills will be assessed by the Peabody Developmental Motor Scales 2nd Edition and Time on-task will be measured by observing children in their classroom. The outcomes of this study will be used to implement sustainable physical activity programming for preschoolers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise

Intervention

Behavioral:
• Active Play planned movement program
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.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	An accelerometer attached at the wrist will measure physical activity over 24 hours for 5 days at baseline and 12 weeks	12 weeks
Primary	Body composition	Percent body fat, ratio of fat mass to lean mass, will be assessed with electrical impedance.	12 weeks
Primary	Fundamental motor skills	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
Primary	Time on Task	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