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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will be community dwelling and have no life-threatening conditions or diseases that would alter their body composition from what is typical for their age, sex, ethnicity, and BMI. Overall, participants must be ambulatory, able to withstand lying flat on the DXA table for up to 10 minutes, stand without aid for 2 minutes, weigh less than 440 lbs and be of generally good health.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percent body fat	total body	6 months
circumferences	waist, hip, upper arms, and mid-thighs	6 months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Publications and helpful links

General Publications

• Majmudar MD, Chandra S, Yakkala K, Kennedy S, Agrawal A, Sippel M, Ramu P, Chaudhri A, Smith B, Criminisi A, Heymsfield SB, Stanford FC. Smartphone camera based assessment of adiposity: a validation study. NPJ Digit Med. 2022 Jun 29;5(1):79. doi: 10.1038/s41746-022-00628-3.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-012-PBRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No