Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Central FITT, Inc.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Central FITT, Inc
ClinicalTrials.gov Identifier:
NCT00487344
First received: June 15, 2007
Last updated: July 2, 2007
Last verified: May 2007
  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:

  1. FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.
  2. 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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00487344     History of Changes
Other Study ID Numbers: CF-01-D-0001
Study First Received: June 15, 2007
Last Updated: July 2, 2007
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

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014