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Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients

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ClinicalTrials.gov Identifier: NCT00670969
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Brief Summary:
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 or disease
Obesity

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.

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients
Study Start Date : May 2008
Actual Primary Completion Date : February 10, 2014
Actual Study Completion Date : February 10, 2014

Group/Cohort
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



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


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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

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

Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00670969     History of Changes
Other Study ID Numbers: 27265
First Posted: May 2, 2008    Key Record Dates
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