Before-School Physical Activity Intervention in Elementary School Children
| Tracking Information | |||||
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| First Received Date ICMJE | December 27, 2011 | ||||
| Last Updated Date | May 15, 2013 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01505244 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Before-School Physical Activity Intervention in Elementary School Children | ||||
| Official Title ICMJE | Before-School Physical Activity Intervention in Elementary School Children: A Pilot Study | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Physical Activity | ||||
| Intervention ICMJE | Behavioral: Before-School Physical Activity
3 days/week of before-school moderate to vigorous physical activity
Other Name: before-school physical activity |
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| Study Arm (s) | Experimental: Physical Activity
Before-school moderate to vigorous physical activity 3 days/week
Intervention: Behavioral: Before-School Physical Activity |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | May 2013 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 11 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01505244 | ||||
| Other Study ID Numbers ICMJE | M12-031 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Connie Tompkins, PhD, University of Vermont | ||||
| Study Sponsor ICMJE | University of Vermont | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Vermont | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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