Back to resultsNutrition and Soccer for Pediatric Overweight and Obesity
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Youth Soccer
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, overweight
Eligibility Criteria
Inclusion Criteria: obese or overweight 4th grade public school student in Starkville Exclusion Criteria: unable to run or physical disease or disability
Sites / Locations
- Leach Chiropractic Clinic, Inc.
Outcomes
Primary Outcome Measures
BMI
Secondary Outcome Measures
My Tips for Families Quiz
Full Information
NCT ID
NCT00365651
First Posted
August 15, 2006
Last Updated
May 18, 2007
Sponsor
Leach Chiropractic Clinic
Collaborators
Mississippi University for Women, MUW Southern Women's Institute
1. Study Identification
Unique Protocol Identification Number
NCT00365651
Brief Title
Nutrition and Soccer for Pediatric Overweight and Obesity
Official Title
Multi Intervention Approach to Pediatric Overweight and Obesity: A Randomized Control Group Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Leach Chiropractic Clinic
Collaborators
Mississippi University for Women, MUW Southern Women's Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
obesity, overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Youth Soccer
Primary Outcome Measure Information:
Title
BMI
Time Frame
5 months
Secondary Outcome Measure Information:
Title
My Tips for Families Quiz
Time Frame
5 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
obese or overweight 4th grade public school student in Starkville
Exclusion Criteria:
unable to run or physical disease or disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Leach, DC, MS(c)
Organizational Affiliation
Leach Chiropractic Clinic, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joyce M Yates, Ed.D.
Organizational Affiliation
Mississippi University for Women
Official's Role
Study Chair
Facility Information:
Facility Name
Leach Chiropractic Clinic, Inc.
City
Starkville
State/Province
Mississippi
ZIP/Postal Code
39759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nutrition and Soccer for Pediatric Overweight and Obesity
We'll reach out to this number within 24 hrs