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

Obesity Clinical Trial

— MEASURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854421
• Other study ID #: 2020-012-PBRC
• Status: Completed
• Start date: August 12, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: April 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 DXA, BodPod, BIA, manual anthropometry, and previously validated 3D optical scanners.

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. - BodPod estimates whole body volume, fat mass, and fat-free mass of the body using variations in air pressure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Being either male or female
• Being from 21 to 80 years of age
• Having a body weight of less than 440 pounds
• Being willing to comply with the study procedures

Exclusion Criteria:

• Being pregnant or attempting to become pregnant
• Having medical implants such as a pacemaker or metal joint replacements
• Having undergone any previous body altering procedures such as breast augmentation or amputation
• Having a body weight greater than 440 pounds

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• VBC
Body 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent body fat	total body	6 months
Primary	circumferences	waist, hip, upper arms, and mid-thighs	6 months