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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487344
Recruitment Status : Unknown
Verified May 2007 by Central FITT, Inc.
Recruitment status was:  Recruiting
First Posted : June 18, 2007
Last Update Posted : July 3, 2007
Information provided by:
Central FITT, Inc

June 15, 2007
June 18, 2007
July 3, 2007
June 2007
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Pre and Post-Bioelectrical Impedance Body Fat Analysis [ Time Frame: 2 months ]
Same as current
Complete list of historical versions of study NCT00487344 on Archive Site
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Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations
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:

  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.
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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Health Services Research
  • Procedure: Non-Personalized Meal Planning
  • Procedure: Personalized Meal Planning and Dietetic Consultation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
November 2007
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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
Sexes Eligible for Study: All
25 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Central FITT, Inc
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Study Chair: Judith Brooks, Phd Eastern Michigan University CHHS Thesis Committee
Study Chair: Anahita Mistry, PhD Eastern Michigan University-CHHS Thesis Committee
Central FITT, Inc
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP