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A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices
This study has been completed.
Sponsored by: Microlife
Information provided by: Microlife
ClinicalTrials.gov Identifier: NCT00502931
  Purpose

With the number of individuals becoming overweight or obese, healthcare professionals are in need of accurate, reliable, and convenient tools to help personalize weight loss programs. Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka “Gem”) was introduced as a convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy needs. Several validation and comparison studies were conducted to determine if the Gem device is accurate and reliable. The purpose of this study was to conduct a systematic review of previous studies that evaluated the accuracy and reliability of the Gem devices.


Condition
Resting Metabolic Rate

U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Case Control, Retrospective Study
Official Title: A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children

Further study details as provided by Microlife:

Study Start Date: November 2006
  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Random or counterbalanced assignment of participants to eliminate measurement bias; similar subject positioning for both Gem and reference system measurement or adjustment to a measurement for positioning differences; and use of a measurement protocol that is similar to the established “best practice” guidelines for employing indirect calorimetry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502931

Locations
United States, Colorado
Microlife Health Solutions
Golden, Colorado, United States, 80401
Sponsors and Collaborators
Microlife
Investigators
Principal Investigator: Scott O McDoniel, M.Ed. Microlife USA, Inc.
  More Information

Study ID Numbers: ML003
Study First Received: July 16, 2007
Last Updated: July 16, 2007
ClinicalTrials.gov Identifier: NCT00502931  
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009



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