Clinical trial NCT00487344: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: 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
Lead sponsor: Central FITT, Inc
Sponsor class: OTHER
First posted: 2007-06-18
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

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 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

Primary outcomes:
measure: Pre and Post-Bioelectrical Impedance Body Fat Analysis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmond
country: United States
facility: Central FITT Inc
state: Oklahoma
Study officials:
affiliation: Eastern Michigan University CHHS Thesis Committee
name: Judith Brooks, Phd
role: STUDY_CHAIR
affiliation: Eastern Michigan University-CHHS Thesis Committee
name: Anahita Mistry, PhD
role: STUDY_CHAIR
References: