NCT01885325

Brief Summary

The study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and reduce the risk of obesity in preschool children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
708

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

3.8 years

First QC Date

May 20, 2013

Last Update Submit

April 16, 2019

Conditions

Keywords

Physical ActivitySedentary BehaviorPreschool Children

Outcome Measures

Primary Outcomes (1)

  • Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA)

    MVPA was assessed using an accelerometer. Participants wore the accelerometer during all waking hours for 5 consecutive weekdays. MVPA was determined by applying count cutpoints to the accelerometer data and calculating minutes spent above the MVPA threshold (minutes per hour).

    Measured at baseline and 10 months for each wave of data collection

Secondary Outcomes (3)

  • Change in Minutes of Sedentary Behavior

    Measured at baseline and 10 months for each wave of data collection

  • Change in Physical Activity Energy Expenditure (PAEE)

    Measured at baseline and 10 months for each wave of data collection

  • Change in Body Mass Index (BMI)

    Measured at baseline and 10 months for each wave of data collection

Study Arms (2)

Physical Activity Preschool Intervention

EXPERIMENTAL

Preschools randomized to the multi-component physical activity preschool intervention received four major components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical Activity in classroom, academic lessons), and enhancing the social environment to promote Physical Activity.

Other: Physical Activity Preschool Intervention

Control

NO INTERVENTION

The preschools in the control group did not receive the intervention

Interventions

Preschools randomized to the multi-component physical activity preschool intervention received four major components:Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical activity in classroom, academic lessons), and enhancing the social environment to promote PA.The focus in the physical education classes, recess, daily lessons, and reduction of sedentary time will be on providing activities that 3-to 5-year-old children enjoy.

Physical Activity Preschool Intervention

Eligibility Criteria

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

You may qualify if:

  • All children from participating K-4 classrooms at the participating schools were invited to participate.

You may not qualify if:

  • Children were excluded only if they had a condition that would limit data collection using an accelerometer (e.g., non-ambulatory children)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Pate RR, Brown WH, Pfeiffer KA, Howie EK, Saunders RP, Addy CL, Dowda M. An Intervention to Increase Physical Activity in Children: A Randomized Controlled Trial With 4-Year-Olds in Preschools. Am J Prev Med. 2016 Jul;51(1):12-22. doi: 10.1016/j.amepre.2015.12.003. Epub 2016 Jan 20.

  • Pfeiffer KA, Saunders RP, Brown WH, Dowda M, Addy CL, Pate RR. Study of Health and Activity in Preschool Environments (SHAPES): study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children. BMC Public Health. 2013 Aug 7;13:728. doi: 10.1186/1471-2458-13-728.

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Russell R Pate, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2013

First Posted

June 24, 2013

Study Start

August 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 18, 2019

Record last verified: 2019-04