InBody Validation Study

Validation of the InBody 770® for the Assessment of Body Composition

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02635958

Acronym

InBody

Enrollment

176

Registered

2015-12-21

Start date

2015-12-31

Completion date

2019-12-31

Last updated

2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation Study

Keywords

Body Mass Index, BMI, InBody, iDXA, validation

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.

Detailed description

This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Body Composition Measures	1 day	compare body composition measures between InBody and iDXA

Countries

United States

Outcome results