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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04563637
• Other study ID #: U1111-1250-0418
• Status: Terminated
• Start date: April 23, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Centennial Medical Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 492
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Centennial Medical Group	Elkridge	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Centennial Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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