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Completed

NCT Number: NCT05744791

Active Play Intervention for Preschoolers

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.

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Key information

Conditions

Exercise Behavior Motor Activity

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Play planned movement program

Behavioral

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.

Primary outcomes

  1. 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

  2. Body composition

    Time frame: 12 weeks

    Percent body fat, ratio of fat mass to lean mass, will be assessed with electrical impedance.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

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

Acronym: Active Play

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2023
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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