Obesity
Conditions
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
Interventions
DEVICEVBC
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.
Sponsors
Amazon, Inc.
Massachusetts General Hospital
Pennington Biomedical Research Center
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Body Mass Index |
| Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | within a single, 3-hour evaluation | Comparison of Body Fat Percentage estimates to DXA references classified by Sex |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 8/12/2020 through 10/21/2020 to undergo body composition assessments at one of two locations, Pennington Biomedical Research Center (PBRC) in Baton Rouge, Louisiana or the Weight Center of Massachusetts General Hospital (MGH) in Boston Massachusetts. Participants assessed at PBRC were recruited from the surrounding community using advertisements promoted by the facility's Recruitment Department. Those assessed at MGH were ongoing patients seen at the center.
Participants by arm
| Arm | Count |
|---|---|
| Male Participants 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. | 52 |
| Female Participants 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. | 82 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Removed from the final analysis due to poor image quality. | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Male Participants | Female Participants |
|---|---|---|---|
| Age, Continuous | 43 Years STANDARD_DEVIATION 14.7 | 43.1 Years STANDARD_DEVIATION 14.4 | 43 Years STANDARD_DEVIATION 14.8 |
| Body Mass Index (BMI) | 29.7 Kilogram per square meter STANDARD_DEVIATION 6.5 | 30.0 Kilogram per square meter STANDARD_DEVIATION 5.6 | 29.5 Kilogram per square meter STANDARD_DEVIATION 7 |
| DXA %BF | 35.2 Percentage STANDARD_DEVIATION 8.7 | 28.6 Percentage STANDARD_DEVIATION 6.4 | 39.4 Percentage STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 47 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 4 Participants |
| Height | 167.8 Centimeters STANDARD_DEVIATION 10.2 | 175.6 Centimeters STANDARD_DEVIATION 8.7 | 163.0 Centimeters STANDARD_DEVIATION 7.6 |
| Hip Circumference | 109.4 Centimeters STANDARD_DEVIATION 13.2 | 108.2 Centimeters STANDARD_DEVIATION 11.5 | 110.1 Centimeters STANDARD_DEVIATION 14.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 11 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 81 Participants | 31 Participants | 50 Participants |
| Sex: Female, Male Female | 82 Participants | 0 Participants | 82 Participants |
| Sex: Female, Male Male | 52 Participants | 52 Participants | 0 Participants |
| Waist Circumference | 98.5 Centimeters STANDARD_DEVIATION 15.7 | 102.2 Centimeters STANDARD_DEVIATION 14.3 | 92.2 Centimeters STANDARD_DEVIATION 16.3 |
| Waist-to-hip Ratio | 0.90 Ratio STANDARD_DEVIATION 0.08 | 0.94 Ratio STANDARD_DEVIATION 0.08 | 0.87 Ratio STANDARD_DEVIATION 0.07 |
| Weight | 84.0 Kilograms STANDARD_DEVIATION 20.8 | 92.8 Kilograms STANDARD_DEVIATION 19.7 | 78.3 Kilograms STANDARD_DEVIATION 19.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 82 |
| other Total, other adverse events | 0 / 52 | 0 / 82 |
| serious Total, serious adverse events | 0 / 52 | 0 / 82 |
Outcome results
Primary
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
Time frame: within a single, 3-hour evaluation
Population: A total of 406 adults were screened for this study. Of those,199 met all inclusion and exclusion criteria and were considered eligible. 138 participants were enrolled into the clinical study and 134 participants (64 from MGH and 70 from PBRC) were included in the final analysis; four participants (2.9%) were removed from the final analysis due to poor image quality. Participants at PBRC underwent ADP (N = 70). Note that DXA images were never used, only their derived Body Fat percentage.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone Visual Body Composition (VBC) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 2.16 Total Body Fat Percentage | Standard Deviation 1.4 |
| Smartphone Visual Body Composition (VBC) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 1.90 Total Body Fat Percentage | Standard Deviation 1.4 |
| Smartphone Visual Body Composition (VBC) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 2.50 Total Body Fat Percentage | Standard Deviation 1.8 |
| FitBit Aria 2 (cBIA 1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 3.02 Total Body Fat Percentage | Standard Deviation 2.3 |
| FitBit Aria 2 (cBIA 1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 6.36 Total Body Fat Percentage | Standard Deviation 3.5 |
| FitBit Aria 2 (cBIA 1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 4.44 Total Body Fat Percentage | Standard Deviation 1.8 |
| Tanita BF-684W (cBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 4.31 Total Body Fat Percentage | Standard Deviation 3.6 |
| Tanita BF-684W (cBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 5.75 Total Body Fat Percentage | Standard Deviation 3.3 |
| Tanita BF-684W (cBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 5.04 Total Body Fat Percentage | Standard Deviation 14.3 |
| Renpho ES-24M-W/B (cBIA 3) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 6.00 Total Body Fat Percentage | Standard Deviation 4.9 |
| Renpho ES-24M-W/B (cBIA 3) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 7.66 Total Body Fat Percentage | Standard Deviation 4.6 |
| Renpho ES-24M-W/B (cBIA 3) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 4.60 Total Body Fat Percentage | Standard Deviation 4.6 |
| InBody S10 (pBIA1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 2.49 Total Body Fat Percentage | Standard Deviation 1.4 |
| InBody S10 (pBIA1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 4.29 Total Body Fat Percentage | Standard Deviation 2.2 |
| InBody S10 (pBIA1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 2.63 Total Body Fat Percentage | Standard Deviation 2 |
| Quantum IV (pBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 4.41 Total Body Fat Percentage | Standard Deviation 2.8 |
| Quantum IV (pBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 5.58 Total Body Fat Percentage | Standard Deviation 2.6 |
| Quantum IV (pBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 3.82 Total Body Fat Percentage | Standard Deviation 3.1 |
| BOD POD ADP | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI > 30 | 3.67 Total Body Fat Percentage | Standard Deviation 2.3 |
| BOD POD ADP | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI 25-29.9 | 2.30 Total Body Fat Percentage | Standard Deviation 1.9 |
| BOD POD ADP | Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index | BMI < 25 | 3.31 Total Body Fat Percentage | Standard Deviation 2.2 |
Primary
Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex
Comparison of Body Fat Percentage estimates to DXA references classified by Sex
Time frame: within a single, 3-hour evaluation
Population: total of 406 adults were screened for this study. Of those,199 met all inclusion and exclusion criteria and were considered eligible. 138 participants were enrolled into the clinical study and 134 participants (64 from MGH and 70 from PBRC) were included in the final analysis; four participants (2.9%) were removed from the final analysis due to poor image quality. Participants at PBRC underwent ADP (N = 70). Note that DXA images were never used, only their derived Body Fat percentage.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone Visual Body Composition (VBC) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 1.88 Total Body Fat Percentage | Standard Deviation 1.3 |
| Smartphone Visual Body Composition (VBC) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 2.34 Total Body Fat Percentage | Standard Deviation 1.6 |
| FitBit Aria 2 (cBIA 1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 4.53 Total Body Fat Percentage | Standard Deviation 5 |
| FitBit Aria 2 (cBIA 1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 4.45 Total Body Fat Percentage | Standard Deviation 3.3 |
| Tanita BF-684W (cBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 6.23 Total Body Fat Percentage | Standard Deviation 13.4 |
| Tanita BF-684W (cBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 4.10 Total Body Fat Percentage | Standard Deviation 3.1 |
| Renpho ES-24M-W/B (cBIA 3) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 4.11 Total Body Fat Percentage | Standard Deviation 3.3 |
| Renpho ES-24M-W/B (cBIA 3) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 6.89 Total Body Fat Percentage | Standard Deviation 5.3 |
| InBody S10 (pBIA1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 3.37 Total Body Fat Percentage | Standard Deviation 2.4 |
| InBody S10 (pBIA1) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 2.98 Total Body Fat Percentage | Standard Deviation 1.8 |
| Quantum IV (pBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 5.01 Total Body Fat Percentage | Standard Deviation 3 |
| Quantum IV (pBIA 2) | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 4.54 Total Body Fat Percentage | Standard Deviation 2.9 |
| BOD POD ADP | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Male Participants | 3.50 Total Body Fat Percentage | Standard Deviation 2.4 |
| BOD POD ADP | Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex | Female Participants | 2.90 Total Body Fat Percentage | Standard Deviation 2.1 |