NCT00670969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2014

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

5.8 years

First QC Date

April 30, 2008

Last Update Submit

June 16, 2017

Conditions

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Validate handheld calorimeter against a portable device

    1 hour

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.)

You may qualify if:

  • Age at least 18 years (no upper limit).
  • Able to fast overnight.
  • Have a BMI no less than 25 kg/m2.

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abigail E Schubert, MS, BA

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

May 1, 2008

Primary Completion

February 10, 2014

Study Completion

February 10, 2014

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations