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
Information provided by:
Penn State University
First received: April 30, 2008
Last updated: May 1, 2008
Last verified: April 2008
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients
Primary Outcome Measures:
- Validate handheld calorimeter against a portable device [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2009 (Final data collection date for primary outcome measure)
People who will have the portable measurement taken first and handheld measurement taken second
People who will have the handheld measurement taken first and portable measurement taken second
- 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.
- 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.)
- Age at least 18 years (no upper limit).
- Able to fast overnight.
- Have a BMI no less than 25 kg/m2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670969
|Penn State Milton S. Hershey Medical Center
|Hershey, Pennsylvania, United States, 17033 |
|Contact: Kevin Gleeson, MD 717-531-5687 firstname.lastname@example.org |
|Principal Investigator: Abigail E Schubert, MS, BA |
|Sub-Investigator: David C Frankenfield, MS, BA |
Penn State University
||Abigail E Schubert, MS, BA
||Milton S. Hershey Medical Center
No publications provided
||Abigail Schubert, Penn State Milton S. Hershey Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 30, 2008
||May 1, 2008
||United States: Institutional Review Board
Keywords provided by Penn State University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
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