Lifestyle Related Disease Management With Wearable Device and Mobile Application

September 4, 2018 updated by: Jeong-Whun Kim, Seoul National University Hospital

A Study of the Management of the Patient's Disease Based on the Life Log Data of Patient With Lifestyle-related Diseases Through a Wearable Device and Mobile App

In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback coaching.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 136-036
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Study participants must agree to support by him/herself at enroll time
  • Patient without severe cardiopulmonary disease, cancer, or other acute diseases
  • Patient must be over BMI > 23 kg/m2

Exclusion Criteria:

  • Patient who did not agree with this study
  • Patient with severe cardiopulmonary disease, cancer, or other acute diseases
  • Patient who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized lifestyle intervention group
Personalized lifestyle intervention group Patients who use mobile healthcare service application and receive personal feedback from clinician
Behavioral: Personalized healthcare service
Personalized healthcare service, such as exercise recommendation, lifestyle activity coaching, health data monitoring
No Intervention: Conventional group
Patients with conventional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Measuring weight change
Baseline and after 2 weeks, 4 weeks of lifestyle modification

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition change
Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Measuring body composition
Baseline and after 2 weeks, 4 weeks of lifestyle modification
Laboratory test result change
Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Obstructive sleep apnea test
Baseline and after 2 weeks, 4 weeks of lifestyle modification

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Jeong-Whun Kim, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2017

Primary Completion (Actual)

June 22, 2018

Study Completion (Actual)

August 22, 2018

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

June 25, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • B-1706/405-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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