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

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT04854421

Collaborator

(none)

Enrollment

Location

4.3

Actual Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: VBC

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

Study Design

Study Type:

Observational

Actual Enrollment :

70 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 12, 2020

Actual Primary Completion Date :

Dec 21, 2020

Actual Study Completion Date :

Dec 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
healthy adults Community dwelling and have no life-threatening conditions or diseases that would alter body composition from what is typical for their age, sex, ethnicity, and BMI.	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.

Arm

Intervention/Treatment

healthy adults

Community dwelling and have no life-threatening conditions or diseases that would alter body composition from what is typical for their age, sex, ethnicity, and BMI.

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.

Outcome Measures

Primary Outcome Measures

percent body fat [6 months]
total body
circumferences [6 months]
waist, hip, upper arms, and mid-thighs

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

Pennington Biomedical Research Center

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Steven Heymsfield, Professor, George A. Gray Endowed Chair, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT04854421

Other Study ID Numbers:

2020-012-PBRC

First Posted:

Apr 22, 2021

Last Update Posted:

Apr 22, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 22, 2021