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

NCT ID: NCT00487344

Last Updated: 2007-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Interventions

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Non-Personalized Meal Planning

Intervention Type PROCEDURE

Personalized Meal Planning and Dietetic Consultation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central FITT, Inc

OTHER

Sponsor Role lead

Principal Investigators

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Judith Brooks, Phd

Role: STUDY_CHAIR

Eastern Michigan University CHHS Thesis Committee

Anahita Mistry, PhD

Role: STUDY_CHAIR

Eastern Michigan University-CHHS Thesis Committee

Locations

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Central FITT Inc

Edmond, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stacy D Buzan, MS

Role: CONTACT

[email protected]
405-503-2759

Michael Buzan, MS

Role: CONTACT

[email protected]
405-503-2758

Facility Contacts

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Stacy D Buzan, MS

Role: primary

[email protected]
405-503-2759

Michael J Buzan, BS

Role: backup

[email protected]
405-503-2758

Other Identifiers

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CF-01-D-0001

Identifier Type: -

Identifier Source: org_study_id