NCT01588392

Brief Summary

The purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration 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

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

April 25, 2012

Last Update Submit

June 7, 2023

Conditions

Keywords

Physical activitypreschoolers

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Physical activity levels at 6-month

    Physical activity levels will be assessed with accelerometer and direct observation system

    Baseline, 3-month and 6-month after study initiation

Study Arms (2)

Short bouts of structured activity

EXPERIMENTAL
Behavioral: Short bouts of structured physical activity

Unstructured physical activity

ACTIVE COMPARATOR
Behavioral: Unstructured physical activity

Interventions

Short bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities. Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months.

Also known as: Instant Recess for preschoolers
Short bouts of structured activity

Unstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice. intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months.

Also known as: Free playtime
Unstructured physical activity

Eligibility Criteria

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

You may qualify if:

  • Attend one of 10 participating preschool centers
  • Attend preschool full-time
  • Children between 2.9 - 5 years of age on the date of baseline assessment

You may not qualify if:

  • Did not have a condition limiting their participation in routine gross-motor playtime at preschool
  • Unable to wear the activity monitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preschool centers in Springfield, MA

Springfield, Massachusetts, 01103, United States

Location

Related Publications (1)

  • Alhassan S, Nwaokelemeh O, Mendoza A, Shitole S, Whitt-Glover MC, Yancey AK. Design and baseline characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. BMC Public Health. 2012 Aug 1;12:582. doi: 10.1186/1471-2458-12-582.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sofiya Alhassan

    University of Massachusetts, Amherst

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2012

First Posted

May 1, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

June 8, 2023

Record last verified: 2023-06

Locations