Metabolic SyndromeNCT04378985
Developing Health Care Service System
A study testing Wearing a Wearable device (Fitbit inspire HR) in people with Metabolic Syndrome, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Wearing a Wearable device (Fitbit inspire HR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Jiwon Lee, Professor, 82-2-2019-3480, INDI5645@yuhs.ac
About this study
Official title: Developing Health Care Service System Based on Participatory Big Data
"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.
Read the 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) "
- Conditions
- Metabolic Syndrome
- Being tested
- Wearing a Wearable device (Fitbit inspire HR)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.'
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wearing a Wearable device (Fitbit inspire HR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Changes in lipid profile (total cholesterol, TG, LDL-C, HDL-C levels) at 8 weeks after smart healthcare intervention.
Measured: 8 weeks after smart healthcare intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start20 Dec 2019
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Won Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378985
- Sponsor's protocol ID
- 3-2019-0226
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Health Care Service System Based on Participatory Big Data
- ClinicalTrials.gov ID
- NCT04378985
- Acronym / sponsor ID
- 3-2019-0226
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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) "
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearing a wearable device (the smart watch) for 8 weeks | Experimental | Device: Wearing a Wearable device (Fitbit inspire HR)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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing a Wearable device (Fitbit inspire HR)'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.' | Device | Wearing a wearable device (the smart watch) for 8 weeks |
Primary outcome
Changes in metabolic parameter (HOMA-IR) at 8 weeks after smart healthcare intervention
Time frame: 8 weeks after smart healthcare intervention
Changes in HOMA-IR (calculated using fasting glucose and insulin level) at 8 weeks after smart healthcare intervention.
1 secondary outcome
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
Time frame: 8 weeks after smart healthcare intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing a Wearable device (Fitbit inspire HR) in people with Metabolic Syndrome, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiwon Lee, Professor (82-2-2019-3480, INDI5645@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in metabolic parameter (HOMA-IR) at 8 weeks after smart healthcare intervention (time frame: 8 weeks after smart healthcare intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.