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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00365651
Other study ID # LEA2006
Secondary ID
Status Completed
Phase Phase 1
First received August 15, 2006
Last updated May 18, 2007
Start date June 2006
Est. completion date December 2006

Study information

Verified date May 2007
Source Leach Chiropractic Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria:

- obese or overweight 4th grade public school student in Starkville

Exclusion Criteria:

- unable to run or physical disease or disability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Youth Soccer


Locations

Country Name City State
United States Leach Chiropractic Clinic, Inc. Starkville Mississippi

Sponsors (3)

Lead Sponsor Collaborator
Leach Chiropractic Clinic Mississippi University for Women, MUW Southern Women's Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary BMI 5 months
Secondary My Tips for Families Quiz 5 months
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