Clinical Trials Directory

Trials / Completed

CompletedNCT04854421

Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage

Status
Completed
Phase
Study type
Observational
Enrollment
138 (actual)
Sponsor
Pennington Biomedical Research Center · Academic / Other
Sex
All
Age
21 Years – 80 Years
Healthy volunteers
Accepted

Summary

This research study is designed to validate the precision and accuracy of body measurement and composition results from a novel 2D imaging device that operates through a smart-phone application. Measurement references will be obtained through dual energy x-ray absorptiometry, air displacement plethysmography, bioelectrical impedance analysis, manual anthropometry, and previously validated 3D optical scanners.

Detailed description

Participation in this study will require a single 3-hour visit to complete. Each person will be asked to arrive at PBRC wearing easily removable gym-style clothing. Upon checking in, they will first complete the informed consent process, then have their vital signs checked, and then women of child-bearing potential will also have a urine sample taken. Outpatient clinic procedures will be followed by a series of body size and composition assessments that will require an outfit of minimal clothing. Clean spandex shorts, sports bras, and lycra caps will be provided. * Anthropometric measurements including hip, waist, arms, and thighs circumferences will be collected by a trained observer using a calibrated tape measure. * Body shape will be measured digitally using 2D and 3D optical devices that optimize light patterns to calculate depth. * Bioelectrical Impedance Analysis measures the amount of fat and lean mass in the body using electrodes positioned close to the feet and hands. * Whole body dual-energy X-ray absorptiometry measures the amount of bone, muscle, and fat mass in the body using low energy X-rays. * Air displacement plethysmography estimates whole body volume, fat mass, and fat-free mass of the body using variations in air pressure

Conditions

Interventions

TypeNameDescription
DEVICEVBCBody Composition will be measured using the VBC system that takes under 60 seconds per scan. Image capture for VBC will include taking a series of four photos using a smartphone camera. Data from the camera will be downloaded to a local computer and then securely sent to the cloud for automated analysis and results generation. We will conduct two consecutive scans (image captures) for each research participant.

Timeline

Start date
2020-08-12
Primary completion
2020-12-21
Completion
2020-12-21
First posted
2021-04-22
Last updated
2024-08-22
Results posted
2024-08-22

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04854421. Inclusion in this directory is not an endorsement.