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Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Penn State University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00670969
First received: April 30, 2008
Last updated: May 1, 2008
Last verified: April 2008
History of Changes

April 30, 2008
May 1, 2008
May 2008
May 2009   (final data collection date for primary outcome measure)
Validate handheld calorimeter against a portable device [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00670969 on ClinicalTrials.gov Archive Site
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Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients
Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients

The purpose of this study is to determine, in a group of overweight or obese volunteers, if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate compared to a portable indirect calorimeter.
  1. Background and Rationale: With the growing number of overweight and obese Americans, health professionals need accurate and convenient tools to help personalize weight loss programs. Portable indirect calorimetry measurements are more expensive than handheld devices and often limited to research setting only, making them impractical for clinical use. Additionally equations used to estimate resting metabolic rate may be significantly inaccurate in overweight patients. Several studies have been conducted to determine the accuracy of handheld devices, however none have been done in the overweight and obese populations. If handheld calorimeters can accurately measure resting metabolic rate in overweight and obese patients, these tests may be used to improve and personalize weight management programs.
  2. Key Objectives: To determine in a group of overweight or obese volunteers if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Major Inclusion & Exclusion Criteria: Age at least 18 years (no upper limit). Able to fast overnight. Have a BMI no less than 25 kg/m2.

Method of Identification of Subjects/Samples/Medical Records: Participants will be recruited with a flyer. Interested individuals will contact the investigators who will ask basic eligibility questions. If eligible, pre-test requirements will be explained to the participant (12 hour fast, avoidance of physical activity and smoking for the same time period.)
Obesity
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  • A
    People who will have the portable measurement taken first and handheld measurement taken second
  • B
    People who will have the handheld measurement taken first and portable measurement taken second
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age at least 18 years (no upper limit).
  • Able to fast overnight.
  • Have a BMI no less than 25 kg/m2.

Exclusion Criteria:

  • All others
Both
18 Years and older
Yes
Contact: Abigail E Schubert, MS 717-531-7081 aschubert@hmc.psu.edu
United States
 
NCT00670969
27265
No
Abigail Schubert, Penn State Milton S. Hershey Medical Center
Penn State University
Not Provided
Principal Investigator: Abigail E Schubert, MS, BA Milton S. Hershey Medical Center
Penn State University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP