Back to resultsMyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management
Primary Purpose
Weight Loss, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daily health-related lifestyle modification prescription
Sponsored by
About this trial
This is an interventional supportive care trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- Study participants must agree to support by him/herself at enroll time
- Patients without severe cardiopulmonary disease, cancer, or other acute diseases
- Patients must be over BMI > 23 kg/m2
Exclusion Criteria:
- Patient who did not agree with this study
- Patients with severe cardiopulmonary disease, cancer, or other acute diseases
- Patients who were pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile application user group
Control group
Arm Description
In the active group, participants were educated to modify their lifestyle to lose weight by using a smart phone-based lifestyle app which was designed to collect daily activity and dietary information. The app was composed of two main modules: a diet module, and a physical activity module.
Conventional lifestyle modification
Outcomes
Primary Outcome Measures
Body weight change
weight measurement and calculate BMI(body mass index)
Secondary Outcome Measures
Blood test result change
Blood test and its several results value measurement
Mobile-app usage change
Usage log of mobile application
Full Information
NCT ID
NCT03200119
First Posted
June 20, 2017
Last Updated
June 25, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03200119
Brief Title
MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management
Official Title
A Study of the Management of the Patient's Disease Based on the Life Log Data of Patients With Lifestyle-related Diseases Through a Wearable Device
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
July 26, 2016 (Actual)
Study Completion Date
November 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 from clinicians
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile application user group
Arm Type
Experimental
Arm Description
In the active group, participants were educated to modify their lifestyle to lose weight by using a smart phone-based lifestyle app which was designed to collect daily activity and dietary information. The app was composed of two main modules: a diet module, and a physical activity module.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional lifestyle modification
Intervention Type
Behavioral
Intervention Name(s)
Daily health-related lifestyle modification prescription
Intervention Description
Daily health-related lifestyle modification prescription
Primary Outcome Measure Information:
Title
Body weight change
Description
weight measurement and calculate BMI(body mass index)
Time Frame
baseline and after 4weeks of lifestyle intervention
Secondary Outcome Measure Information:
Title
Blood test result change
Description
Blood test and its several results value measurement
Time Frame
baseline and after 4weeks of lifestyle intervention
Title
Mobile-app usage change
Description
Usage log of mobile application
Time Frame
baseline and after 4weeks of lifestyle intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Study participants must agree to support by him/herself at enroll time
Patients without severe cardiopulmonary disease, cancer, or other acute diseases
Patients must be over BMI > 23 kg/m2
Exclusion Criteria:
Patient who did not agree with this study
Patients with severe cardiopulmonary disease, cancer, or other acute diseases
Patients who were pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se young Jung, MD, MPH
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
patient personal information is confidential according to the hospital's data protection policy
Citations:
PubMed Identifier
29217503
Citation
Ryu B, Kim N, Heo E, Yoo S, Lee K, Hwang H, Kim JW, Kim Y, Lee J, Jung SY. Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper. J Med Internet Res. 2017 Dec 7;19(12):e401. doi: 10.2196/jmir.8867.
Results Reference
derived
Learn more about this trial
MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management
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