ObesityNCT00670969
Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients
An observational study of Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 10 Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.)
Who may be able to join
- Age at least 18 years (no upper limit).
- Able to fast overnight.
- Have a BMI no less than 25 kg/m2.
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate handheld calorimeter against a portable device
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startMay 2008
- Primary completion10 Feb 2014
- Study completion10 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abigail E Schubert, MS, BA, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670969
- Sponsor's protocol ID
- 27265
- Status last verified
- Jun 2017
- First submitted
- 30 Apr 2008
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients
- ClinicalTrials.gov ID
- NCT00670969
- Acronym / sponsor ID
- 27265
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- 10 Feb 2014 (actual)
- Study completion
- 10 Feb 2014 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (3 listed)
- Age at least 18 years (no upper limit).
- Able to fast overnight.
- Have a BMI no less than 25 kg/m2.
Key exclusion criteria (1 listed)
- All others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validate handheld calorimeter against a portable device
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail E Schubert, MS, BA principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate handheld calorimeter against a portable device (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.