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

Completed

• Conditions: Obesity
• Interventions: Device: VBC

• Registration Number: NCT04854421
• Lead Sponsor: Pennington Biomedical Research Center

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 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

Study Timeline

• Study Start: 2020-08-12
• Primary Completion: 2020-12-21
• Study Completion: 2020-12-21
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-22
• Results First Submitted: 2021-05-05
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Results First Posted: 2024-08-22
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy adults	VBC	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.

Primary Outcome Measures

Name	Time	Method
Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex	within a single, 3-hour evaluation	Comparison of Body Fat Percentage estimates to DXA references classified by Sex
Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index	within a single, 3-hour evaluation	Comparison of Body Fat Percentage estimates to DXA references classified by Body Mass Index

Trial Locations

Locations (2)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States