Nutrition and Soccer for Pediatric Overweight and Obesity
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 15, 2006 | ||||||||
| Last Updated Date | May 18, 2007 | ||||||||
| Start Date ICMJE | June 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
BMI [ Time Frame: 5 months ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Body Mass Index | ||||||||
| Change History | Complete list of historical versions of study NCT00365651 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
My Tips for Families Quiz [ Time Frame: 5 months ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
My Tips for Families Quiz | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Nutrition and Soccer for Pediatric Overweight and Obesity | ||||||||
| Official Title ICMJE | Multi Intervention Approach to Pediatric Overweight and Obesity: A Randomized Control Group Trial | ||||||||
| Brief Summary | This study will examine whether two months of youth soccer, combined with a single brief behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females. |
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| Detailed Description | Female overweight and obese public school students will be recruited during the summer of 2006 based on FitnessGram testing done by graduate students at MSU during their prior (4th grade) school year. After receiving informed consent from parent/child, the subjects will be checked for height/weight and other screening criteria, then exposed to 2005 My Pyramid for Kids, "Tips for Families" information, and watch a short 8 minute DVD that discusses the importance of exercise and fitness by way of interviewing two club level female soccer players of equivalent age. Subjects will then be randomly assigned to fall youth soccer in Starkville, or spring youth soccer, after first phase data collection occurs in November, 2006. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Youth Soccer | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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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 | Completed | ||||||||
| Enrollment ICMJE | 22 | ||||||||
| Completion Date | December 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 9 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00365651 | ||||||||
| Other Study ID Numbers ICMJE | LEA2006 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Leach Chiropractic Clinic | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Leach Chiropractic Clinic | ||||||||
| Verification Date | May 2007 | ||||||||
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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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