Health BehaviorNCT04563637
A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat Percentage
An observational study of Health Behavior, run by Centennial Medical Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Computer based vision application by video and whole body dual energy x-ray absorptiometry scan
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 492 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females between ages 18 and 100
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat
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.
Read the detailed 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.
- Conditions
- Health Behavior
- Being tested
- Computer based vision application by video, whole body dual energy x-ray absorptiometry scan
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer based vision application by videoDiagnostic test
patients will be tested by computer based analysis of a video as well as by dexa scan.
whole body dual energy x-ray absorptiometry scanRadiation
Also called Dexa scan
subjects will receive a whole body dual energy x-ray absorptiometry scan to measure their body fat percentage
| Study group | Role | What they receive |
|---|---|---|
| Computer Based Vision | A 15 second long video will be obtained at the research site using a smart phone or tablet. Then subjects will undergo a whole body dual energy x-ray absorptiometry scan . Then the subject will go home and take a second 15 second long video. The videos will then be analyzed by computer based vision application and the body fat percentage measured by dual energy x-ray absorptiometry scan will be compared. Receives: Diagnostic Test: Computer based vision application by video; Radiation: whole body dual energy x-ray absorptiometry scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months
Secondary outcomes (1)
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start23 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Sponsor terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centennial Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Geller, Principal investigator, Centennial Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563637
- Sponsor's protocol ID
- U1111-1250-0418
- Status last verified
- Feb 2022
- First submitted
- 20 Sep 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat
- ClinicalTrials.gov ID
- NCT04563637
- Acronym / sponsor ID
- U1111-1250-0418
- Conditions
- Health Behavior
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor terminated due to lack of funding
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Centennial Medical GroupIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer Based Vision | – | Diagnostic Test: Computer based vision application by video, Radiation: whole body dual energy x-ray absorptiometry scanA 15 second long video will be obtained at the research site using a smart phone or tablet. Then subjects will undergo a whole body dual energy x-ray absorptiometry scan . Then the subject will go home and take a second 15 second long video. The videos will then be analyzed by computer based vision application and the body fat percentage measured by dual energy x-ray absorptiometry scan will be compared. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females between ages 18 and 100
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Computer based vision application by videopatients will be tested by computer based analysis of a video as well as by dexa scan. | Diagnostic test | Computer Based Vision |
| whole body dual energy x-ray absorptiometry scanAlso: Dexa scansubjects will receive a whole body dual energy x-ray absorptiometry scan to measure their body fat percentage | Radiation | Computer Based Vision |
Primary outcome
variance in body fat percentage between computervision application and dexa scan
Time frame: 8 months
Variance between body fat percentage measured by smart phone applicaiton compared to body fat percentage as measured by DEXA scan
1 secondary outcome
abdominal circumference
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Sponsor terminated due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- 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 Geller principal investigator
Centennial Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by Centennial Medical Group at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Sponsor terminated due to lack of funding). Results are not available in the source record.
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?
variance in body fat percentage between computervision application and dexa scan (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.