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.
Behavioral: Daily health-related lifestyle modification prescription
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.

Sponsor

Seoul National University Hospital

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.

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 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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