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
  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

Resource links provided by NLM:


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 ]

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:
  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

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
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, see Learn About Clinical Studies.

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 Milton S. Hershey Medical Center
  More Information

No publications provided

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

Keywords provided by Penn State University:
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014