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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

Tracking Information
First Submitted Date  ICMJE June 25, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date September 6, 2018
Actual Study Start Date  ICMJE June 22, 2017
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
Weight change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
Measuring weight change
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
  • Body composition change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Measuring body composition
  • Laboratory test result change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Obstructive sleep apnea test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Related Disease Management With Wearable Device and Mobile Application
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Obesity
  • Life Style Induced Illness
Intervention  ICMJE Behavioral: Personalized healthcare service
Personalized healthcare service, such as exercise recommendation, lifestyle activity coaching, health data monitoring
Study Arms  ICMJE
  • Experimental: Personalized lifestyle intervention group
    Personalized lifestyle intervention group Patients who use mobile healthcare service application and receive personal feedback from clinician
    Intervention: Behavioral: Personalized healthcare service
  • No Intervention: Conventional group
    Patients with conventional care
Publications * Kim JW, Ryu B, Cho S, Heo E, Kim Y, Lee J, Jung SY, Yoo S. Impact of Personal Health Records and Wearables on Health Outcomes and Patient Response: Three-Arm Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 4;7(1):e12070. doi: 10.2196/12070.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 25, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 22, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03200223
Other Study ID Numbers  ICMJE B-1706/405-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeong-Whun Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jeong-Whun Kim, PhD Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP