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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

December 27, 2011
May 15, 2013
September 2011
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01505244 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Before-School Physical Activity Intervention in Elementary School Children
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Physical Activity
Behavioral: Before-School Physical Activity
3 days/week of before-school moderate to vigorous physical activity
Other Name: before-school physical activity
Experimental: Physical Activity
Before-school moderate to vigorous physical activity 3 days/week
Intervention: Behavioral: Before-School Physical Activity
Tompkins CL, Hopkins J, Goddard L, Brock DW. The effect of an unstructured, moderate to vigorous, before-school physical activity program in elementary school children on academics, behavior, and health. BMC Public Health. 2012 Jul 5;12:300. doi: 10.1186/1471-2458-12-300.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
7 Years to 11 Years
Yes
Contact: Connie Tompkins, PhD 802-656-3817 Connie.Tompkins@uvm.edu
United States
 
NCT01505244
M12-031
No
Connie Tompkins, PhD, University of Vermont
University of Vermont
Not Provided
Principal Investigator: Connie L Tompkins, PhD University of Vermont
University of Vermont
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP