Developing Health Care Service System
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Wearing a Wearable device (Fitbit inspire HR)
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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 provided consent for inclusion in the study
- 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
Exclusion Criteria:
- Individuals who did not provide consent for inclusion in the study or individuals who did not provide complete data
- 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
Sites / Locations
- Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wearing a wearable device (the smart watch) for 8 weeks
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Changes in lipid profile (total cholesterol, TG, LDL-C, HDL-C levels) at 8 weeks after smart healthcare intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04378985
Brief Title
Developing Health Care Service System
Official Title
Developing Health Care Service System Based on Participatory Big Data
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
These changes enable the development of healthcare solutions that allow users to actively engage in healthcare and provide appropriate care measures to sufficiently delay or prevent chronic diseases, thereby minimizing the financial losses of the individuals and the society. In particular, chronic diseases such as metabolic syndrome can be prevented or delayed through healthy lifestyle habits. Controversy regarding the effectiveness of using wearable devices and mobile health applications for maintaining lifestyle habits and losing weight exists. Additionally, a study assessing the health of the participants and the disease prevention care for the participants using the genetic data and the lifelog data by the wearable device has not been conducted yet. Therefore, the objective is to operate a lifestyle correction program for examinees who visited a family medicine and health checkup center to develop a user-participation health and disease prevention care system using genetic data and lifelog data. From adults who visited a family medicine and health checkup center, the following should be performed: (1) collect a variety of clinical information, including lifestyle data, physical information, metabolic parameters, genetic information, and metagenomes, which can affect chronic diseases; (2) establish a service model that combines lifestyle data, examination data, and genetic data and analyzes and identifies one's health level through a smartphone application; and (3) examine the effects on the metabolic parameters, lifestyle data, and metagenome (gut microbiome) after using the device (smart healthcare).This pilot study aimed to provide personalized "my data" by linking clinical data and personal lifestyle patterns of the participants who visited a family medicine and examination center.
From adults who visited a family medicine and health check-up center, the following should be performed:
Collect a variety of clinical information, including lifestyle data, physical information, metabolic parameters, genetic information, and metagenomes, which can affect chronic diseases
Establish a service model that combines lifestyle data, examination data, and genetic data and analyzes and identifies one's health level through a smartphone application
Examine the effects on the metabolic parameters, lifestyle data, and metagenome (gut microbiome) after using the device (smart healthcare) "
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
384 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wearing a wearable device (the smart watch) for 8 weeks
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wearing a Wearable device (Fitbit inspire HR)
Intervention Description
'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.'
Primary Outcome Measure Information:
Title
Changes in metabolic parameter (HOMA-IR) at 8 weeks after smart healthcare intervention
Description
Changes in HOMA-IR (calculated using fasting glucose and insulin level) at 8 weeks after smart healthcare intervention.
Time Frame
8 weeks after smart healthcare intervention
Secondary Outcome Measure Information:
Title
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
Description
Changes in lipid profile (total cholesterol, TG, LDL-C, HDL-C levels) at 8 weeks after smart healthcare intervention.
Time Frame
8 weeks after smart healthcare intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 provided consent for inclusion in the study
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
Exclusion Criteria:
Individuals who did not provide consent for inclusion in the study or individuals who did not provide complete data
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwon Lee, Professor
Phone
82-2-2019-3480
Email
INDI5645@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwon Lee, Professor
Phone
82-2-2019-3480
Email
INDI5645@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Developing Health Care Service System
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