ObesityPhase 1NCT00365651
Nutrition and Soccer for Pediatric Overweight and Obesity
A Phase 1 study testing Youth Soccer in people with Obesity and Overweight, run by Leach Chiropractic Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Youth Soccer
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2006
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- obese or overweight 4th grade public school student in Starkville
Who cannot join
- unable to run or physical disease or disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Leach Chiropractic Clinic, Inc.
Starkville, Mississippi, 39759
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Youth Soccer
- Keywords
- obesity, overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth SoccerProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 5 months
Secondary outcomes (1)
My Tips for Families Quiz
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leach Chiropractic Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Mississippi University for Women, MUW Southern Women's Institute
- Investigators
- Robert A Leach, DC, MS(c), Principal investigator, Leach Chiropractic Clinic, IncJoyce M Yates, Ed.D., Study chair, Mississippi University for Women
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365651
- Sponsor's protocol ID
- LEA2006
- Status last verified
- May 2007
- First submitted
- 15 Aug 2006
- Last updated
- 21 May 2007
- Results posted
- No
- Data monitoring committee
- Yes