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

2. juli 2007 opdateret af: 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:

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.

Studieoversigt

Status

Ukendt

Betingelser

Fedme

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Oklahoma
  - Edmond, Oklahoma, Forenede Stater, 73013
    - Rekruttering
    - Central FITT Inc
    - Kontakt:
      
      Stacy D Buzan, MS
      
      Telefonnummer: 405-503-2759
      
      E-mail: oktrial@yahoo.com
    - Kontakt:
      
      Michael J Buzan, BS
      
      Telefonnummer: 405-503-2758
      
      E-mail: centralfitt@sbcglobal.net
    - Ledende efterforsker:
      
      Stacy D Buzan, MS, BS, AAS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 45 år (Voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Sundhedstjenesteforskning
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Enkelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Pre and Post-Bioelectrical Impedance Body Fat Analysis Tidsramme: 2 months	2 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Central FITT, Inc

Efterforskere

Studiestol: Judith Brooks, Phd, Eastern Michigan University CHHS Thesis Committee
Studiestol: Anahita Mistry, PhD, Eastern Michigan University-CHHS Thesis Committee

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2007

Studieafslutning (Forventet)

1. november 2007

Datoer for studieregistrering

Først indsendt

15. juni 2007

Først indsendt, der opfyldte QC-kriterier