- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200119
MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management
June 25, 2017 updated by: Se Young Jung, Seoul National University Hospital
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Mobile application user group
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.
|
Daily health-related lifestyle modification prescription
|
No Intervention: Control group
Conventional lifestyle modification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight change
Time Frame: baseline and after 4weeks of lifestyle intervention
|
weight measurement and calculate BMI(body mass index)
|
baseline and after 4weeks of lifestyle intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood test result change
Time Frame: baseline and after 4weeks of lifestyle intervention
|
Blood test and its several results value measurement
|
baseline and after 4weeks of lifestyle intervention
|
Mobile-app usage change
Time Frame: baseline and after 4weeks of lifestyle intervention
|
Usage log of mobile application
|
baseline and after 4weeks of lifestyle intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Se young Jung, MD, MPH, 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.
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 20, 2016
Primary Completion (Actual)
July 26, 2016
Study Completion (Actual)
November 18, 2016
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 25, 2017
First Posted (Actual)
June 27, 2017
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 25, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1504/296-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
patient personal information is confidential according to the hospital's data protection policy
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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