Before-School Physical Activity Intervention in Elementary School Children

December 1, 2014 updated by: Connie Tompkins, PhD, University of Vermont

Before-School Physical Activity Intervention in Elementary School Children: A Pilot Study

Children in the U.S. exhibit low levels of physical activity. In addition to the overall physical health and fitness benefits with increasing levels of physical activity, improvements in academic performance, mental cognition, and behavior may occur. Despite these benefits, opportunities for children to participate in physical activity are being reduced, particularly in schools.

The proposed study is a pilot program with approximately 100 children ages 7-11 years expected to participate. All study participants will partake in a testing and measures session which will include body composition measures, nutrition and physical activity questionnaires, and curriculum-based measures. Following the first testing and measures session, 50 of the 100 children will participate in a 10-12 week, before-school, moderate to vigorous physical activity (MVPA) program. This program will consist of non-competitive, MVPA and occur 3 days/week at their school. Subsequent to the physical activity program, all 100 children will then participate in a follow-up testing and measures session.

The objective of this proposed pilot study is to determine the feasibility of implementing a before-school, physical activity program as well as explore the effect the program may have on academic performance and health measures.

Study Overview

Status

Completed

Conditions

Detailed Description

The current guidelines for physical activity recommend that children should partake in regular, moderate to vigorous intensity physical activity for 60 minutes or more each day. Unfortunately, children in the U.S. are not meeting these goals. Moreover, physical inactivity in these children is considered a significant, contributing factor to childhood overweight and obesity. In addition to the importance of physical activity for overall physical health and fitness, classroom behavior, academic skills, and attention may also improve in children with increasing physical activity. There appears to be a positive association between physical activity and academic performance, mental cognition, and behavior in children, however, further research to delineate the ideal duration and intensity is warranted particularly in elementary school children. As schools in recent years have eliminated recess and/or physical education due to growing pressure to increase academic scores, creative solutions to engage children in physical activity are desperately needed. And with the vast majority of children's time spent in school, this may be the ideal location for implementing physical activity interventions.

The purpose of this pilot study is to determine the feasibility of implementing a before-school, physical activity program. Furthermore, the effect the physical activity program may have on academic performance, and health measures will also be examined through several methods.

The results of the proposed study may help design future physical activity interventions and provide insight to the relationship between physical activity and academic performance.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • 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

    • Vermont
      • Colchester, Vermont, United States, 05446
        • Malletts Bay School

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

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3rd, 4th, or 5th grader currently attending Malletts Bay school
  • Group A participants only: Approval to participate in a moderate to vigorous physical activity program from the child's pediatrician

Exclusion Criteria:

  • Children will only be excluded from the study if both groups have reached their maximum capacity (n=50 in each group).
  • Group A participants only: Approval to participate in a moderate to vigorous physical activity program not received from the child's pediatrician
  • If a child has a known handicap and/or other medical condition and requires individualized education program (IEP) assistance, then the child may be excluded from the study if IEP accommodations are not available.

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Activity
Before-school moderate to vigorous physical activity 3 days/week
3 days/week of before-school moderate to vigorous physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in curriculum-based measures at 12 weeks
Time Frame: 12 weeks
The curriculum-based measures are unique methods of academic performance as these are sensitive to and are validated to monitor progress. Curriculum-based measures are easy to administer, can be given as often as wanted/needed, and provide immediate feedback. Progress monitoring focuses on individualized decision making in general and special education with respect to academic skill development at the elementary grades. Progress monitoring can be conducted frequently and is designed to estimate rates of improvement.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in health-related measures at 12 weeks
Time Frame: 12 weeks
Health-related measures will be measured at baseline as well as 12 weeks to assess changes in weight (kg), height (cm), waist, hip, and neck circumferences (cm), resting heart rate (bpm), and blood pressure (mmHg).
12 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Connie L Tompkins, PhD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

September 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • M12-031

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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