Energy Cost for Holding a MedGem® Indirect Calorimeter
MEDGEM
1 other identifier
interventional
40
1 country
1
Brief Summary
The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJune 6, 2018
June 1, 2018
11 months
January 26, 2017
June 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Resting Metabolic Rate (RMR)
Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart
3 hours
Study Arms (2)
Not holding, then holding the MedGem®
EXPERIMENTALSubjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.
Holding, then not holding the MedGem®
ACTIVE COMPARATORSubjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.
Interventions
Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®
Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®
Eligibility Criteria
You may qualify if:
- Age between 18-65 y
- BMI 25-40 kg/m2
You may not qualify if:
- Diabetes mellitus
- Current smoker
- Presently on a weight loss regimen
- Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs
- Claustrophobia
- Pregnant or breastfeeding
- Congestive heart failure
- Chronic kidney disease
- Pacemaker or other metal implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pennington Biomedical Research Centerlead
- WW International Inccollaborator
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Ravussin, PhD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Executive Director for Clinical Science
Study Record Dates
First Submitted
January 26, 2017
First Posted
January 30, 2017
Study Start
February 13, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
June 6, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share
The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.