- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365651
Nutrition and Soccer for Pediatric Overweight and Obesity
May 18, 2007 updated by: Leach Chiropractic Clinic
Multi Intervention Approach to Pediatric Overweight and Obesity: A Randomized Control Group Trial
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
Starkville, Mississippi, United States, 39759
- Leach Chiropractic Clinic, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- obese or overweight 4th grade public school student in Starkville
Exclusion Criteria:
- unable to run or physical disease or disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BMI
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
My Tips for Families Quiz
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert A Leach, DC, MS(c), Leach Chiropractic Clinic, Inc
- Study Chair: Joyce M Yates, Ed.D., Mississippi University for Women
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
August 15, 2006
First Submitted That Met QC Criteria
August 15, 2006
First Posted (Estimate)
August 17, 2006
Study Record Updates
Last Update Posted (Estimate)
May 21, 2007
Last Update Submitted That Met QC Criteria
May 18, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEA2006
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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