search
Back to results

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

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Non-Personalized Meal Planning
Personalized Meal Planning and Dietetic Consultation
Sponsored by
Central FITT, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring 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, YMCA, UCO, OSU, OU, clinics, physicians, surgery, pills, financial, money

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central FITT IncRecruiting

Outcomes

Primary Outcome Measures

Pre and Post-Bioelectrical Impedance Body Fat Analysis

Secondary Outcome Measures

Full Information

First Posted
June 15, 2007
Last Updated
July 2, 2007
Sponsor
Central FITT, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00487344
Brief Title
Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Central FITT, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
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, YMCA, UCO, OSU, OU, clinics, physicians, surgery, pills, financial, money

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Non-Personalized Meal Planning
Intervention Type
Procedure
Intervention Name(s)
Personalized Meal Planning and Dietetic Consultation
Primary Outcome Measure Information:
Title
Pre and Post-Bioelectrical Impedance Body Fat Analysis
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy D Buzan, MS
Phone
405-503-2759
Email
oktrial@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Buzan, MS
Phone
405-503-2758
Email
centralfitt@sbcglobal.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Brooks, Phd
Organizational Affiliation
Eastern Michigan University CHHS Thesis Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anahita Mistry, PhD
Organizational Affiliation
Eastern Michigan University-CHHS Thesis Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Central FITT Inc
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy D Buzan, MS
Phone
405-503-2759
Email
oktrial@yahoo.com
First Name & Middle Initial & Last Name & Degree
Michael J Buzan, BS
Phone
405-503-2758
Email
centralfitt@sbcglobal.net
First Name & Middle Initial & Last Name & Degree
Stacy D Buzan, MS, BS, AAS

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs