Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations - Full Text View

Sponsored by:	Central FITT, Inc
Information provided by:	Central FITT, Inc
ClinicalTrials.gov Identifier:	NCT00487344

Purpose

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.

Condition	Intervention	Phase
Obesity	Procedure: Non-Personalized Meal Planning Procedure: Personalized Meal Planning and Dietetic Consultation	Phase I

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Body Fat Reduction in Overweight and Obese Subjects Utilizing Personalized Low-Fat Meal Plans vs. Non-Personalized Low-Fat Meal Plans.

Further study details as provided by Central FITT, Inc:

Primary Outcome Measures:

Pre and Post-Bioelectrical Impedance Body Fat Analysis [ Time Frame: 2 months ]

Estimated Enrollment:	32
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2007

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.

Eligibility

Ages Eligible for Study:	25 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487344

Contacts

Contact: Stacy D Buzan, MS	405-503-2759	oktrial@yahoo.com
Contact: Michael Buzan, MS	405-503-2758	centralfitt@sbcglobal.net

Locations

United States, Oklahoma
Central FITT Inc	Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Stacy D Buzan, MS 405-503-2759 oktrial@yahoo.com
Contact: Michael J Buzan, BS 405-503-2758 centralfitt@sbcglobal.net
Principal Investigator: Stacy D Buzan, MS, BS, AAS

Sponsors and Collaborators

Central FITT, Inc

Investigators

Study Chair:	Judith Brooks, Phd	Eastern Michigan University CHHS Thesis Committee
Study Chair:	Anahita Mistry, PhD	Eastern Michigan University-CHHS Thesis Committee

More Information

Study ID Numbers:	CF-01-D-0001
Study First Received:	June 15, 2007
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00487344
Health Authority:	United States: Institutional Review Board

Keywords provided by Central FITT, Inc:

medicaid
insurance
education
clinical
trial
healthcare
reimburse
pay
free
assist
study
oklahoma
edmond
Oklahoma City
diet

nutrition
weight loss
body
fat
obese
overweight
health
medical
therapy
meal plan
jenny craig
weight watcher
LA Weightloss
Bryan Attebery
Results

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 16, 2009