- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07003516
- Original Trial
Validation of Artificial Intelligence-based Digital Anthropometry Applications for Estimating Body Composition.
Validation and Development of Digital Anthropometry Methodologies.
Study Overview
Status
Conditions
Detailed Description
Anthropometric measurements are commonly used to assess body composition, morphology, and health-related parameters in diverse populations. Although it is an economical and practical method in the field, the COVID-19 pandemic has propelled worldwide research on digital anthropometry. Machine learning, a fusion of artificial intelligence and data mining, promises to enhance the collection and analysis of data in applications that rely on cineanthropometric data.
Instead of replacing traditional methods, digital anthropometry represents a significant opportunity to improve the precision, validity, practicality, and implementation of self-monitoring procedures under professional supervision. The CyberMetron Project by DBSS aims to conduct additional research and increase scientific literacy among professionals to raise awareness about digital anthropometry.
Data will be collected from residents of both genders and with different levels of physical activity. The population sample will be obtained through internal calls to both students and administrative staff at participating universities and through an open call. Anthropometric variables of restricted and complete profiles established by ISAK will be measured, along with digital images taken at different distances from the lens. Regarding the sample size, it will be conducted by convenience (non-probabilistic), primarily considering university students, administrative staff, and other potentially eligible adults who respond to the study announcement and sign the informed consent.
Finally, all statistical analyses will be performed within the statistical computing environment R v4.2.3, with a statistical significance of P<0.05. Pearson's correlation coefficient (r), adjusted determination coefficient (aR²), and Lin's concordance correlation coefficient (ρc) will be used for comparative analysis between main variables taken by conventional anthropometry and digital anthropometry. The coefficient of repeated measures correlation (rrm) will be employed to assess the strength of the linear association between variables, while the intraclass correlation coefficient (ICC), with its corresponding 95% confidence interval (95% CI), and Finn's coefficient (rF) will be used to evaluate reliability between evaluators. Additionally, the Bland-Altman analysis will be applied for the concordance analysis between conventional and digital anthropometry.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Diego A Bonilla
- Phone Number: +573203352050
- Email: dabonilla@dbss.pro
Study Locations
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Bogota, Colombia, 111221
- Recruiting
- Fundación Universitaria del Area Andina
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Contact:
- Luis A. Cardozo, MSc
- Phone Number: +573133270327
- Email: lcardozo11@areandina.edu.co
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Antioquia
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Medellin, Antioquia, Colombia, 050021
- Recruiting
- Universidad CES
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Contact:
- Katherine Franco-Hoyos, MSc
- Phone Number: +573002719536
- Email: kfranco@ces.edu.co
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-
Risaralda
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Pereira, Risaralda, Colombia, 110231
- Recruiting
- Fundación Universitaria del Area Andina
-
Contact:
- Juan C Granados, MSc
- Phone Number: +573174609496
- Email: jcgranados@dbss.pro
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- People over 18 years of age (under 60 years of age)
- Persons born and living in the cities of the participating universities
- Signed informed consent to undergo evaluation of anthropometric measurements.
Exclusion Criteria:
- Body mass ≥ 160 kg
- Amputations
- Pregnant women.
- People with implants or prostheses.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Sedentary
It will be obtained by open call for both students and administrative staff at the CES University.
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Athletes
Under the collaboration framework between DBSS international SAS and ARTHROS Physiotherapy and Exercise Center, a sample of professional athletes from different sports disciplines will be invited to participate.
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Physically active
DBSS will open a call for participation to get a sample of personal trainers and physically active population that want to be involved as sample participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometric measurements
Time Frame: 40 Minutes
|
Anthropometric measurements of restricted and complete profile established by ISAK will be taken, specifically the basic measurements, perimeters (cm), lengths (cm) and diameters (cm).
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40 Minutes
|
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Body composition and morphology by digital anthropometry
Time Frame: 15 Minutes
|
The evaluation will be performed using a mobile application that processes standardized frontal and lateral photographs as input.
Participants will assume the ISAK anatomical position, which corresponds to standing upright with relaxed arms at sides (hands in neutral position) and feet positioned at biacromial width (aligned with the application's frame markers).
After sufficient processing time for automated report generation, we will export data to the participant's designated file and store the generated 3D avatar.
|
15 Minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurements of dual-energy X-ray absorptiometry
Time Frame: 10 Minutes
|
Estimation of fat mass and fat-free mass by DXA will be used as the reference method.
|
10 Minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Diego A Bonilla, PhD, Research Division, DBSS International SAS.
- Study Chair: Jorge L Petro, PhD, Research Division, DBSS International SAS
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CyberMetron_DBSS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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