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Completed

NCT Number: NCT04854421

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

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VBC

Device

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.

Primary outcomes

  1. Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index

    Time frame: within a single, 3-hour evaluation

    Comparison of Body Fat Percentage estimates to DXA references classified by Body Mass Index

  2. Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex

    Time frame: within a single, 3-hour evaluation

    Comparison of Body Fat Percentage estimates to DXA references classified by Sex

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Amazon, Inc.
  • Massachusetts General Hospital

Registry information

Acronym: MEASURE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2021
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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