NCT04378985

Brief Summary

"Increased health risks and diseases are believed to be caused by multilevel interactions of genetic and environmental factors (including lifestyle habits). Considering the recent advancements in genetic analysis, wearable devices, and big data analysis techniques, collecting and analyzing personal genetic information, lifelogs, and environmental data and predicting the exact health risks of individuals could be possible.

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
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 20, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

April 29, 2020

Last Update Submit

May 6, 2020

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Changes in metabolic parameter (HOMA-IR) at 8 weeks after smart healthcare intervention

    Changes in HOMA-IR (calculated using fasting glucose and insulin level) at 8 weeks after smart healthcare intervention.

    8 weeks after smart healthcare intervention

Secondary Outcomes (1)

  • Changes in other metabolic parameters, inflammatory parameters, metagenome related to the gut microbiome, and sleep quality, diet, and exercise at 8 weeks after smart healthcare intervention

    8 weeks after smart healthcare intervention

Study Arms (1)

Wearing a wearable device (the smart watch) for 8 weeks

EXPERIMENTAL

The smart watch to be used in this study is Fitbit Inspire HR. This is a device that has a high worldwide use rate and has active research on its accuracy. It is worn like a normal watch, and it can check heart rate, exercise level, energy consumed, and sleep quality. The values can be checked in real-time on a smartphone application.

Device: Wearing a Wearable device (Fitbit inspire HR)

Interventions

Wearing a Wearable device (Fitbit inspire HR)DEVICE

'Wearing a wearable device (the smart watch) for 8 weeks The smart watch to be used in this study is Fitbit Inspire HR. This is a device that has a high worldwide use rate and has active research on its accuracy. It is worn like a normal watch, and it can check heart rate, exercise level, energy consumed, and sleep quality. The values can be checked in real-time on a smartphone application.'

Wearing a wearable device (the smart watch) for 8 weeks

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Korean adults aged between 20 and 65 years who visited a family medicine and health checkup center
  • Individuals who understand and are fluent in Korean language
  • Individuals who can complete the study without participating in other intervention studies (medicine, diet, exercise) during the whole research duration
  • Individuals who have no restrictions on their participation in physical activities during the whole research duration

You may not qualify if:

  • Individuals with cognitive dysfunction or inability in using wearable devices
  • Individuals with history of infectious brain diseases, head trauma, thyroid diseases, and substance abuse
  • Individuals with vision, hearing, and speech impairments that can affect examinations
  • Individuals considered unfit to participate in this study by researchers
  • Individuals who do not use smartphones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Jiwon Lee, Professor

CONTACT

82-2-2019-3480INDI5645@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Yonsei University College of Medicine,

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 7, 2020

Study Start

December 20, 2019

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations

KR(1)