An interventional study of Wearing a Wearable device (Fitbit inspire HR) in Metabolic Syndrome, sponsored by Gangnam Severance Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-05-07.
Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Prevention
"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.
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:
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 384 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
'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.'
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.
Time frame: 8 weeks after smart healthcare intervention
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.
Time frame: 8 weeks after smart healthcare intervention
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gangnam Severance Hospital