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

NCT04854421 | Completed Results

• 1 other identifier: PBRC 2020-012
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

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

  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 Sex

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

  within a single, 3-hour evaluation

Study Arms (1)

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

Interventions

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.

healthy adults

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Amazon, Inc.: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2517, United States

Location

Related Publications (1)

• 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.

  PMID: 35768575 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Steven Heymsfield
• Organization: Pennington Biomedical Research Center

steven.heymsfield@pbrc.edu

(225) 763-2541

Study Officials

• Steven Heymsfield, M.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, George A. Gray Endowed Chair

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: August 12, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)