ObesityMEASURENCT04854421

Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage

An observational study of Obesity, run by Pennington Biomedical Research Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: VBC
Type of treatment: Medical device
How many people: 138 participants
Where: 2 sitesUnited States
Study dates: 12 Aug 2020to 21 Dec 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Massachusetts General Hospital
Boston, Massachusetts, 02114-2517

Other trials in United States

About this study

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.

Read the 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

Conditions: Obesity
Being tested: VBC
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VBCDevice
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.

Study groups in NCT04854421
Study group	Role	What they receive
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. Receives: Device: VBC

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: within a single, 3-hour evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 202021 Dec 2020

First posted22 Apr 2021
Study start12 Aug 2020
Primary completion21 Dec 2020
Study completion21 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Ecologic or community
Time perspective: Cross-sectional
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04854421
Sponsor's protocol ID: PBRC 2020-012
Acronym: MEASURE
Status last verified: Apr 2024
First submitted: 18 Apr 2021
Last updated: 22 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35768575

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage
ClinicalTrials.gov ID: NCT04854421
Acronym / sponsor ID: MEASURE / PBRC 2020-012
Conditions: Obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Amazon, Inc., Massachusetts General Hospital
Study start: 12 Aug 2020 (actual)
Primary completion: 21 Dec 2020 (actual)
Study completion: 21 Dec 2020 (actual)
First posted: 22 Apr 2021 (actual)
Results: Posted 22 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Ecologic or community
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
healthy adults	–	Device: VBCCommunity 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.

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VBCBody 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.	Device	healthy adults

Primary outcome

Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index
Time frame: 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
Time frame: within a single, 3-hour evaluation
Comparison of Body Fat Percentage estimates to DXA references classified by Sex

Results and safety

Results posted to the registry on 22 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Male Participants	54	52
Female Participants	84	82

Primary outcome: Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index

Time frame: within a single, 3-hour evaluation. Mean (Standard Deviation). Unit: Total Body Fat Percentage

Measure	Smartphone Visual Body Composition (VBC) n = 134	FitBit Aria 2 (cBIA 1) n = 123	Tanita BF-684W (cBIA 2) n = 131	Renpho ES-24M-W/B (cBIA 3) n = 131	InBody S10 (pBIA1) n = 70	Quantum IV (pBIA 2) n = 64	BOD POD ADP n = 70
BMI < 25	2.50 (1.8)	6.36 (3.5)	5.75 (3.3)	7.66 (4.6)	4.29 (2.2)	4.41 (2.8)	3.31 (2.2)
BMI 25-29.9	1.90 (1.4)	3.02 (2.3)	5.04 (14.3)	6.00 (4.9)	2.49 (1.4)	3.82 (3.1)	2.30 (1.9)
BMI > 30	2.16 (1.4)	4.44 (1.8)	4.31 (3.6)	4.60 (4.6)	2.63 (2.0)	5.58 (2.6)	3.67 (2.3)

Population analysed: 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.

Primary outcome: Comparison of Body Fat Percentage Estimates to DXA References Classified by Sex

Time frame: within a single, 3-hour evaluation. Mean (Standard Deviation). Unit: Total Body Fat Percentage

Measure	Smartphone Visual Body Composition (VBC) n = 134	FitBit Aria 2 (cBIA 1) n = 123	Tanita BF-684W (cBIA 2) n = 131	Renpho ES-24M-W/B (cBIA 3) n = 131	InBody S10 (pBIA1) n = 70	Quantum IV (pBIA 2) n = 64	BOD POD ADP n = 70
Male Participants	1.88 (1.3)	4.53 (5.0)	6.23 (13.4)	4.11 (3.3)	3.37 (2.4)	5.01 (3.0)	3.50 (2.4)
Female Participants	2.34 (1.6)	4.45 (3.3)	4.10 (3.1)	6.89 (5.3)	2.98 (1.8)	4.54 (2.9)	2.90 (2.1)

Population analysed: 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.

Adverse events

Time frame: Participants were monitored over the course of a single 4-hour visit to the facility.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Male Participants	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Female Participants	0 of 82 (0%)	0 of 82 (0%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35768575Majmudar 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Heymsfield, M.D. principal investigator

Pennington Biomedical Research Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Pennington Biomedical Research Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Body Fat Percentage Estimates to DXA References Classified by Body Mass Index (time frame: within a single, 3-hour evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.