NCT05744791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

February 16, 2023

Last Update Submit

March 2, 2023

Conditions

Keywords

PreschoolersActive PlayTeacher guided interventions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Body composition

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

    12 weeks

  • 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

  • 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

Study Arms (2)

Active Play Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Preschool teachers will continue to implement their regular curriculum. This consists of one outdoor play opportunity for 30 minutes each day.

Interventions

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.

Active Play Intervention

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 5 years of age
  • attending one of the preschools 5 days a week.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Preschool children will not be aware of which intervention they are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two preschools. One will be randomized to the intervention and one to the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

August 14, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations