Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lifestyle Related Disease Management With Wearable Device and Mobile Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200223
Recruitment Status : Terminated (Study was completed)
First Posted : June 27, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jeong-Whun Kim, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Life Style Induced Illness Behavioral: Personalized healthcare service Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Weight change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Measuring weight change


Secondary Outcome Measures :
  1. Body composition change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Measuring body composition

  2. Laboratory test result change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Obstructive sleep apnea test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200223


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 136-036
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Study Chair: Jeong-Whun Kim, PhD Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jeong-Whun Kim, Clinical professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03200223    
Other Study ID Numbers: B-1706/405-301
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No