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
Recruitment status was Not yet recruiting
Sponsor:
Penn State University
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00670969
First received: April 30, 2008
Last updated: May 1, 2008
Last verified: April 2008
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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:
- 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 | 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 May 22, 2013