Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients - Full Text View

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

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients

Further study details as provided by Penn State University:

Primary Outcome Measures:

Validate handheld calorimeter against a portable device [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (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:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670969

Contacts


Contact: Abigail E Schubert, MS	717-531-7081	aschubert@hmc.psu.edu

Locations


United States, Pennsylvania
	Penn State Milton S. Hershey Medical Center	Not yet recruiting
	Hershey, Pennsylvania, United States, 17033
	Contact: Kevin Gleeson, MD 717-531-5687 kgleeson@psu.edu
	Principal Investigator: Abigail E Schubert, MS, BA
	Sub-Investigator: David C Frankenfield, MS, BA

Sponsors and Collaborators

Penn State University

Investigators


Principal Investigator:	Abigail E Schubert, MS, BA	Penn State Milton S. Hershey Medical Center

More Information

Responsible Party:	Penn State Milton S. Hershey Medical Center ( Abigail Schubert )
Study ID Numbers:	27265
First Received:	April 30, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00670969
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Obesity

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overnutrition

Overweight

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00670969