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:

  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 Overview

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

Study Contact Backup

Study Locations

    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Central FITT Inc
        • Contact:
        • Contact:
        • 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.

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

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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