NCT03200119

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

June 20, 2017

Last Update Submit

June 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body weight change

    weight measurement and calculate BMI(body mass index)

    baseline and after 4weeks of lifestyle intervention

Secondary Outcomes (2)

  • Blood test result change

    baseline and after 4weeks of lifestyle intervention

  • Mobile-app usage change

    baseline and after 4weeks of lifestyle intervention

Study Arms (2)

Mobile application user group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Conventional lifestyle modification

Interventions

Daily health-related lifestyle modification prescription

Mobile application user group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient who did not agree with this study
  • Patients with severe cardiopulmonary disease, cancer, or other acute diseases
  • Patients who were pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Se young Jung, MD, MPH

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 27, 2017

Study Start

June 20, 2016

Primary Completion

July 26, 2016

Study Completion

November 18, 2016

Last Updated

June 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

patient personal information is confidential according to the hospital's data protection policy