Active Play Intervention for Preschoolers (Active Play)

March 2, 2023 updated by: Danielle D Wadsworth, Auburn University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Auburn University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Auburn University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-217 MR 1009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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