Clinical trial NCT04854421: Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage
Official title: Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Amazon, Inc.
name: Massachusetts General Hospital
First posted: 2021-04-22
Enrollment: 138
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index
timeFrame: within a single, 3-hour evaluation
measure: Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex
timeFrame: within a single, 3-hour evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Pennington Biomedical Research Center
name: Steven Heymsfield, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.