Before-School Physical Activity Intervention in Elementary School Children
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
1 active site
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
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 27, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedDecember 2, 2014
December 1, 2014
1.7 years
December 27, 2011
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in curriculum-based measures at 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 Outcomes (1)
Change from baseline in health-related measures at 12 weeks
12 weeks
Study Arms (1)
Physical Activity
EXPERIMENTALBefore-school moderate to vigorous physical activity 3 days/week
Interventions
3 days/week of before-school moderate to vigorous physical activity
Eligibility Criteria
You may qualify if:
- rd, 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Malletts Bay School
Colchester, Vermont, 05446, United States
Related Publications (1)
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.
PMID: 22537028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Connie L Tompkins, PhD
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 27, 2011
First Posted
January 6, 2012
Study Start
September 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
December 2, 2014
Record last verified: 2014-12