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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Intervention Approach to Pediatric Overweight and Obesity: A Randomized Control Group Trial
- ClinicalTrials.gov ID
- NCT00365651
- Acronym / sponsor ID
- LEA2006
- Conditions
- Obesity, Overweight
- Keywords
- obesity, overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Leach Chiropractic ClinicUniversity, hospital or other
- Collaborators
- Mississippi University for Women, MUW Southern Women's Institute
- Study start
- Jun 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 9 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- obese or overweight 4th grade public school student in Starkville
Key exclusion criteria (1 listed)
- unable to run or physical disease or disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth Soccer | Procedure or surgery | – |
Primary outcome
BMI
Time frame: 5 months
1 secondary outcome
My Tips for Families Quiz
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Leach, DC, MS(c) principal investigator
Leach Chiropractic Clinic, Inc
Joyce M Yates, Ed.D. study chair
Mississippi University for Women
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Youth Soccer in people with Obesity and Overweight, run by Leach Chiropractic Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2007.