NCT04969588

Brief Summary

This perspective observational study will recruited 240 participants for investigating the feasibility of using Microsoft Azure Kinect developer kit as a method for body indices and body composition. Reference methods will be dual energy X-ray absorptiometry and bioelectrical impedance analysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

July 11, 2021

Last Update Submit

August 30, 2021

Conditions

Keywords

AnthropometryBody Composition

Outcome Measures

Primary Outcomes (2)

  • Assess association and agreement in body indices and body composition between Kinect and standard methods.

    Correlation and agreement between depth camera results are compared to the results of dual energy X-ray absorptiometry and bioelectrical impedance analysis.

    36 months

  • Develop and validate Kinect equations to predict body indices and body composition.

    Prediction equations for body indices and body composition are created using dual energy X-ray absorptiometry and bioelectrical impedance analysis as reference tools.

    36 months

Study Arms (1)

Children and adult

Participants aged 6-65 years old are recruited for the measurements of depth camera, bioelectrical impedance analysis and dual energy X-ray absorptiometry.

Diagnostic Test: Microsoft Azure Kinect Developer KitDiagnostic Test: Bioelectrical impedance analyzerDiagnostic Test: Dual Energy X-ray Absorptiometry

Interventions

3D images and 3D joint coordinates are obtained.

Children and adult

Fat mass, fat-free mass and percentage body fat in total body and body segments are estimated.

Children and adult

Skeletal length and body composition are estimated.

Children and adult

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apparently healthy participants aged 6-65 years are recruited for this study within 3 years. Estimated enrolled number are 240. Eligible participants will visit study site once and take the measurements.

You may qualify if:

  • Healthy children and adult
  • Age 6-65 years

You may not qualify if:

  • Chronic illness or chronic medication use (\> 3 months)
  • Pregnant
  • Metal implant(s) or splint(s)
  • Pacemaker implantation
  • Limb defect(s) or injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, 61363, Taiwan

RECRUITING

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Li-Wen Lee, MD, PhD

    Chang Gung Memorial Hospital, Chiayi, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Wen Lee, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Radiologist

Study Record Dates

First Submitted

July 11, 2021

First Posted

July 20, 2021

Study Start

September 1, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations