Before-School Physical Activity Intervention in Elementary School Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
Connie Tompkins, PhD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01505244
First received: December 27, 2011
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Physical Activity
Behavioral: Before-School Physical Activity

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Before-School Physical Activity Intervention in Elementary School Children: A Pilot Study

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Change from baseline in curriculum-based measures at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in health-related measures at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity
Before-school moderate to vigorous physical activity 3 days/week
Behavioral: Before-School Physical Activity
3 days/week of before-school moderate to vigorous physical activity
Other Name: before-school physical activity

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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505244

Contacts
Contact: Connie Tompkins, PhD 802-656-3817 Connie.Tompkins@uvm.edu

Locations
United States, Vermont
Malletts Bay School Recruiting
Colchester, Vermont, United States, 05446
Contact: Pam Reith    802-264-5907      
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Connie L Tompkins, PhD University of Vermont
  More Information

No publications provided by University of Vermont

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Tompkins, PhD, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01505244     History of Changes
Other Study ID Numbers: M12-031
Study First Received: December 27, 2011
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014