A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat Percentage

A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat

This study is being done to test whether a HealthReel computer vision-based software application can estimate body fat percentage with equivalent accuracy to a whole body dual energy x-ray absorptiometry scan.

Study Overview

• Status: Terminated
• Conditions: Health Behavior
• Intervention / Treatment: Diagnostic test: Computer based vision application by video; Radiation: whole body dual energy x-ray absorptiometry scan

Detailed Description

This study is being done to test whether a computer vision-based software application can estimate body fat percentage with equivalent accuracy to a whole body dual energy x-ray absorptiometry scan. The dual energy x-ray absorptiometry scan involves lying on a machine for about 6-10 minutes. It is an open design. The study will also examine whether waist circumference measurement improves the accuracy of the body fat percentage estimate by the computer vision-based application.A total of approximately 492 subjects are planned to take part in this study at one study center.

• Study Type: Observational
• Enrollment (Actual): 492

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and females between ages 18 and 100

Description

Inclusion Criteria:

• Have the ability to provide informed consent before any trial-related activities
• Male or female, age > = 18 at time of signing informed consent
• Have access to and ability to use a smart phone to take a 15 second video from their home

Exclusion Criteria:

• Pregnancy at the time of screening
• Known osteoporosis with a T-score of <-2.5 at hip or spine or pathological fracture of spine
• Cirrhosis of the liver, or presence of ascites

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Computer Based Vision; A 15 second long video will be obtained at the research site using a smart phone or tablet. Then subjects will undergo a whole body dual energy x-ray absorptiometry scan . Then the subject will go home and take a second 15 second long video. The videos will then be analyzed by computer based vision application and the body fat percentage measured by dual energy x-ray absorptiometry scan will be compared.

Diagnostic test: Computer based vision application by video; patients will be tested by computer based analysis of a video as well as by dexa scan.; Radiation: whole body dual energy x-ray absorptiometry scan; subjects will receive a whole body dual energy x-ray absorptiometry scan to measure their body fat percentage; Other Names: Dexa scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variance in body fat percentage between computervision application and dexa scan	Variance between body fat percentage measured by smart phone applicaiton compared to body fat percentage as measured by DEXA scan	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abdominal circumference	Analysis will be undertaken to see if the variance between application and dual energy x-ray absorptiometry is reduced when the abdominal circumference is included in the application or whether inclusion of abdominal circumference does not reduce the variance.	8 months

Collaborators and Investigators

• Sponsor: Centennial Medical Group
• Investigators: Principal Investigator: Steven Geller, Centennial Medical Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: September 20, 2020
• First Posted (ACTUAL): September 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: U1111-1250-0418

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