NCT03200223

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
terminated

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 22, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

June 25, 2017

Last Update Submit

September 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Measuring weight change

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

Secondary Outcomes (2)

  • Body composition change

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

  • Laboratory test result change

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

Study Arms (2)

Personalized lifestyle intervention group

EXPERIMENTAL

Personalized lifestyle intervention group Patients who use mobile healthcare service application and receive personal feedback from clinician

Behavioral: Personalized healthcare service

Conventional group

NO INTERVENTION

Patients with conventional care

Interventions

Personalized healthcare service, such as exercise recommendation, lifestyle activity coaching, health data monitoring

Personalized lifestyle intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 136-036, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong-Whun Kim, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

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 25, 2017

First Posted

June 27, 2017

Study Start

June 22, 2017

Primary Completion

June 22, 2018

Study Completion

August 22, 2018

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations