- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00424918
"Generation Fit and Exerlearning With In the Groove"
Generation-Fit, a Pilot Study of Youth in Maine Middle Schools Using an "Exerlearning" Dance Video Game to Promote Physical Activity During School
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We met with administrators and teachers and obtained consent and assent for this study. After assessing baseline measures (end-of-grade test scores, absenteeism, Pediatric Quality of Life, physical fitness, GEMS Activity Rating Scale, Dennison's measure of sedentary screen time, Physical Activity Enjoyment Scale, BMI%ile, (with a small subset assayed for fasting lipids and glucose, with a smaller subset wearing ActiGraphs for objective measures of activity) we randomized to the intervention or control group.
In our intervention, youth play a dance game at school called "In the Groove", with the goal of 40 additional minutes each week of physical activity during the school hours.
We will obtain change scores and compare the groups to find an effect size for future studies, this this proves acceptable and feasible in Maine schools.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maine
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Portland, Maine, United States, 04012
- Portland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Take Time middle school in Maine with consent/assent
Exclusion Criteria:
- Any condition that prevents a child from doing physical activity on the dance mat like photic seizures, broken leg, blindness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Minutes of activity added in school day.
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Secondary Outcome Measures
Outcome Measure |
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Others
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Quality of Life change scores
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Relation to test scores, absenteeism
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Fitness change scores
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Change in biological endpoints
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ann E Maloney, MD, Research Attending
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MMCRI-3000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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