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Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670969
First Posted: May 2, 2008
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Milton S. Hershey Medical Center
  Purpose
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.

Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Validate handheld calorimeter against a portable device [ Time Frame: 1 hour ]

Enrollment: 101
Study Start Date: May 2008
Study Completion Date: February 10, 2014
Primary Completion Date: February 10, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:
  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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.)

Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670969


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Abigail E Schubert, MS, BA Milton S. Hershey Medical Center
  More Information

Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00670969     History of Changes
Other Study ID Numbers: 27265
First Submitted: April 30, 2008
First Posted: May 2, 2008
Last Update Posted: June 19, 2017
Last Verified: June 2017

Keywords provided by Milton S. Hershey Medical Center:
Obesity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms