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| Name | Class |
|---|---|
| Amazon, Inc. | INDUSTRY |
| Massachusetts General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Heymsfield, M.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35768575 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Female Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | Total Body Fat Percentage | within a single, 3-hour evaluation |
|
Participants were monitored over the course of a single 4-hour visit to the facility.
This was a minimal risk study. The VBC device consists of an external camera that is no more dangerous to a participant that taking his/her picture using a cellular device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. VBC: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Heymsfield | Pennington Biomedical Research Center | (225) 763-2541 | steven.heymsfield@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2020 | Jun 28, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2020 | Jun 28, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Boston |
| Massachusetts |
| 02114-2517 |
| United States |
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.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilogram per square meter |
|
| Waist Circumference | Mean | Standard Deviation | Centimeters |
|
| Hip Circumference | Mean | Standard Deviation | Centimeters |
|
| Waist-to-hip Ratio | Mean | Standard Deviation | Ratio |
|
| DXA %BF | Dual-Energy X-ray Absorptiometry (DXA) percentage of total body fat | Mean | Standard Deviation | Percentage |
|
| OG001 | FitBit Aria 2 (cBIA 1) | Three consumer weight scales capable of BIA-based body composition analysis were included in the protocol: FitBit Aria 2 (Fitbit, San Francisco, CA); Tanita BF-684W (Tanita, Tokyo, Japan); and Renpho ES-24M-W/B (Joicom Corporation, Anaheim, CA). These scales are designated as cBIA 1, cBIA 2, and cBIA 3.(Consumer Bio-Impedance Analysis) |
| OG002 | Tanita BF-684W (cBIA 2) | Three consumer weight scales capable of BIA-based body composition analysis were included in the protocol: FitBit Aria 2 (Fitbit, San Francisco, CA); Tanita BF-684W (Tanita, Tokyo, Japan); and Renpho ES-24M-W/B (Joicom Corporation, Anaheim, CA). These scales are designated as cBIA 1, cBIA 2, and cBIA 3.(Consumer Bio-Impedance Analysis) |
| OG003 | Renpho ES-24M-W/B (cBIA 3) | Three consumer weight scales capable of BIA-based body composition analysis were included in the protocol: FitBit Aria 2 (Fitbit, San Francisco, CA); Tanita BF-684W (Tanita, Tokyo, Japan); and Renpho ES-24M-W/B (Joicom Corporation, Anaheim, CA). These scales are designated as cBIA 1, cBIA 2, and cBIA 3.(Consumer Bio-Impedance Analysis) |
| OG004 | InBody S10 (pBIA1) | All participants also underwent professional BIA (pBIA) at PBRC with an InBody S10 (InBody Co., Seoul, Korea) and at MGH with a RJL system (Quantum IV, RJL Systems, Clinton Township, MI, USA.). The RJL system uses a single frequency (50 Khz) and four gel adhesive electrodes. Instead, InBody is multi-frequency and uses contact electrodes. InBody and RJL are designated as pBIA1 and pBIA 2, respectively, in the sections that follow and were analyzed separately. (Professional Bio-Impedance Analysis). |
| OG005 | Quantum IV (pBIA 2) | All participants also underwent professional BIA (pBIA) at PBRC with an InBody S10 (InBody Co., Seoul, Korea) and at MGH with a RJL system (Quantum IV, RJL Systems, Clinton Township, MI, USA.). The RJL system uses a single frequency (50 Khz) and four gel adhesive electrodes. Instead, InBody is multi-frequency and uses contact electrodes. InBody and RJL are designated as pBIA1 and pBIA 2, respectively, in the sections that follow and were analyzed separately. (Professional Bio-Impedance Analysis). |
| OG006 | BOD POD ADP | Participants who were evaluated at PBRC (N = 70) also had %BF assessed with the BOD POD Air displacement plethysmography (ADP) device (BodPod Gold Standard Body Composition Tracking System, COSMED, Rome, Italy). |
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | Total Body Fat Percentage | within a single, 3-hour evaluation |
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|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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. VBC: 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. | 0 | 82 | 0 | 82 | 0 | 82 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Female Participants |
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