- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00487344
Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations
July 2, 2007 updated by: Central FITT, Inc
Comparison of Body Fat Reduction in Overweight and Obese Subjects Utilizing Personalized Low-Fat Meal Plans vs. Non-Personalized Low-Fat Meal Plans.
The purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age.
Compensation to Eligible Participants:
- FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.
- Each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical purposes of $0.20 per mile. This compensation will be provided to each eligible participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00, contingent upon his or her completion in the study.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Study Rationale: This experiment on the effect that the use of personalized low-fat meal plans has on body fat reduction is important for several reasons.
First, the details of this research study may equip the public with knowledge to select quality nutrition programs for weight loss responsibly.
Second, it may encourage the wellness and fitness community to reconsider the practice of providing clientele with non-personalized meal plans for weight loss, which are not usually designed by accredited dietetic professionals.
Third, this study may benefit dietetic professionals by opening the lines of communication between the wellness community and the dietetic community regarding standards of care, and protecting the public by dispelling harmful and erroneous nutrition advice.
Study Type
Interventional
Enrollment (Anticipated)
32
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 Contact
- Name: Stacy D Buzan, MS
- Phone Number: 405-503-2759
- Email: oktrial@yahoo.com
Study Contact Backup
- Name: Michael Buzan, MS
- Phone Number: 405-503-2758
- Email: centralfitt@sbcglobal.net
Study Locations
-
-
Oklahoma
-
Edmond, Oklahoma, United States, 73013
- Recruiting
- Central FITT Inc
-
Contact:
- Stacy D Buzan, MS
- Phone Number: 405-503-2759
- Email: oktrial@yahoo.com
-
Contact:
- Michael J Buzan, BS
- Phone Number: 405-503-2758
- Email: centralfitt@sbcglobal.net
-
Principal Investigator:
- Stacy D Buzan, MS, BS, AAS
-
-
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
25 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 25 to 45 years of age
- Classified as overweight or obese with body mass index (BMI) measurement between 25 and 50
- Limited to minor chronic health
Exclusion Criteria:
- Individuals with the following health conditions:
- Food allergies
- Food intolerances
- Cancer
- Debilitating joint conditions such as Degenerative Joint Disease (DJD) and Degenerative Disk Disease (DDD)
- Diabetes Mellitus receiving insulin therapy
- Kidney problems
- Menopause
- Polycystic ovarian syndrome (PCOS)
- Currently pregnant or breast feeding
- Using diuretics, chromium, and/or diet pills
- Participants must:
- Live in the following Oklahoma Counties:
- Canadian, Cleveland, Logan, Lincoln, Oklahoma, and Pottawatomie
- Will to travel to Edmond and Oklahoma City, Oklahoma
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pre and Post-Bioelectrical Impedance Body Fat Analysis
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Judith Brooks, Phd, Eastern Michigan University CHHS Thesis Committee
- Study Chair: Anahita Mistry, PhD, Eastern Michigan University-CHHS Thesis Committee
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, 2007
Study Completion (Anticipated)
November 1, 2007
Study Registration Dates
First Submitted
June 15, 2007
First Submitted That Met QC Criteria
June 15, 2007
First Posted (Estimate)
June 18, 2007
Study Record Updates
Last Update Posted (Estimate)
July 3, 2007
Last Update Submitted That Met QC Criteria
July 2, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
- health
- overweight
- surgery
- nutrition
- weight loss
- trial
- healthcare
- education
- diet
- therapy
- obese
- fat
- clinical
- medical
- study
- physicians
- Results
- clinics
- medicaid
- insurance
- reimburse
- pay
- free
- assist
- oklahoma
- edmond
- Oklahoma City
- body
- meal plan
- jenny craig
- weight watcher
- LA Weightloss
- Bryan Attebery
- YMCA
- UCO
- OSU
- OU
- pills
- financial
- money
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF-01-D-0001
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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