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Wearable device (WELT) for prediction of metabolic syndrome and assessment of falls risk

Status Approved

First Submitted Date

2021/02/23
Registered Date

2021/03/30
Last Updated Date

2021/02/23

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006039
Unique Protocol ID	B-2012/652-302
Public/Brief Title	Wearable device (WELT) for prediction of metabolic syndrome and assessment of falls risk
Scientific Title	Wearable device (WELT) for prediction of metabolic syndrome and assessment of falls risk
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	B-2012/652-302
Approval Date	2020-11-30
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Kwang-il Kim
Title	Professor
Telephone	+82-31-787-7032
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Jung-Yeon Choi
Title	Assistant professor
Telephone	+82-31-787-8131
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Jung-Yeon Choi
Title	Assistant professor
Telephone	+82-31-787-8131
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-02-23 Actual
Target Number of Participant	100
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-02-23 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	MINDsncompany
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	MINDsncompany
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	We aim to develop an algorithm that can predict metabolic syndrome and evaluate the risk of falling with walking speed, waist circumference, sitting time, and number of steps in daily life using a wearable device (SMARTBELT WELTPRO) The participants will wear a belt for 4 weeks. The history of falls, risk of falling, sarcopenia, and metabolic syndrome will be evaluated and will be analyzed the correlation with the information collected from the wearable device. The purpose of this study is to develop a method that can easily assess the risk of metabolic syndrome and falls, which are important health concern in middle-age to older population.

Study Summary Information

Lay Summary

We aim to develop an algorithm that can predict metabolic syndrome and evaluate the risk of falling with walking speed, waist circumference, sitting time, and number of steps in daily life using a wearable device (SMARTBELT WELTPRO) 

The participants will wear a belt for 4 weeks. The history of falls, risk of falling, sarcopenia, and metabolic syndrome will be evaluated and will be analyzed the correlation with the information collected from the wearable device.

The purpose of this study is to develop a method that can easily assess the risk of metabolic syndrome and falls, which are important health concern in middle-age to older population.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Screening
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Others (Wearable device (SMARTBELT PRO))
Intervention Description	Volunteers who are males 40 years of age or older and who can walk will be recruited. Participants are asked to wear a wearable device, the WELT, for 4 weeks.
Number of Arms	1
Arm 1	Arm Label Belt user
	Target Number of Participant 100
	Arm Type Experimental
	Arm Description Volunteers who are males 40 years of age or older and who can walk will be recruited. Participants are asked to wear a wearable device, the WELT, for 4 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E88.9)Metabolic disorder, unspecified Accidental Falls Sarcopenia Metabolic syndrome
Rare Disease	No
Inclusion Criteria	Gender Male
	Age 40Year~No Limit
	Description Adult male outpatient over 40 years old who visited Seoul National University Bundang Hospital. A participant who provide written informed consent with sufficient information represented by researcher
Exclusion Criteria	A person who cannot walk independently Those who need help from a cane or walker during daily walking
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Fall risk
Timepoint	Before wearing the belt
Secondary Outcome(s) 1
Outcome	Metabolic syndrome
Timepoint	Before wearing the belt
Secondary Outcome(s) 2
Outcome	Sarcopenia
Timepoint	Before wearing the belt

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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