NCT02635958

Brief Summary

With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

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

Study Start

First participant enrolled

December 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

December 17, 2015

Last Update Submit

May 29, 2020

Conditions

Validation Study

Keywords

Body Mass IndexBMIInBodyiDXAvalidation

Outcome Measures

Primary Outcomes (1)

  • Body Composition Measures

    compare body composition measures between InBody and iDXA

    1 day

Study Arms (4)

Group 1

BMI 18.5 to 24.9

Group 2

BMI 25 to 29.9

Group 3

BMI 30 to 34.9

Group 4

BMI ≥ 35

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.

You may qualify if:

  • Between 18 and 65 years of age
  • Have a Body Mass Index ≥ 18.5 kg/m2

You may not qualify if:

  • Are not English speaking
  • Are younger than 18 years of age
  • Weigh more than 450 lbs
  • Taller than 6'6" due to size constraints of the iDXA
  • Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
  • People having radioactive iodine thyroid treatment.
  • People who have had a nuclear medicine study or a barium X-ray within the last 5 days.
  • People with large amounts of metal in their bodies.
  • People with arthritis of the spine recorded in the medical record.
  • Are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Ryan T Hurt, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 21, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 1, 2019

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

US(1)