Physical Activity Clinical Trial
Official title:
Before-School Physical Activity Intervention in Elementary School Children: A Pilot Study
Verified date | December 2014 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 7 Years to 11 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Malletts Bay School | Colchester | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Change from baseline in health-related measures at 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 | No |
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