NCT01344811

Brief Summary

A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
661

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

April 28, 2011

Last Update Submit

January 29, 2020

Conditions

ObesityMetabolic Syndrome

Keywords

telemonitoringusual caretelehealthhome careHealth Care QualityAccessEvaluation

Outcome Measures

Primary Outcomes (1)

  • Weight Change from Baseline to 24 weeks

    0 and 24 weeks

Secondary Outcomes (10)

  • Body Mass Index (BMI) changes

    0 and 24 weeks

  • Proportion of subjects whose body weight decreased more than 10%

    0 and 24 weeks

  • Changes in body fat rate

    0 and 24 weeks

  • Changes in waist circumference

    0 and 24 weeks

  • Changes in lipid profile

    0 and 24 weeks

  • +5 more secondary outcomes

Study Arms (2)

Telemonitoring group

EXPERIMENTAL

* A Smartphone, body composition analyzer and Pedometer will be provided * transmitting the results to the Smart Care Server via Smartphone * At Smart care Center,care manager will provide remote body weight and activity monitoring and individual obesity case management

Procedure: Telemonitoring

Control group

OTHER

* A weighing scale and Pedometer will be provided * recording in a self diary of body weight and the number of steps

Other: control group

Interventions

TelemonitoringPROCEDURE

The Telemonitoring group will be provided the Smartphone, body composition analyzer and pedometer. They should visit the site once per every 3 months (12 weeks), and measure their body composition during study period. After measurement of body composition, the subjects should make transmit measured information through Smartphone into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote body composition and activity monitoring and individual obesity case management

Also known as: Smartcare System : Telemonitoring
Telemonitoring group
control groupOTHER

The control group will receive a weighting scale and pedometer. They should perform the same weight measurement (minimum three times a week) like the intervention group during the study, and measured results should be recorded in a diary of self body weight and the number of steps. In addition, the subjects should visit the site once per every three months (12 weeks).

Also known as: Self Body Weight measurement
Control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: More than 20 years of age and under 70 years of age.
  • BMI ≥ 25kg/m2
  • Patients with metabolic syndrome (who have more than three of following 5 components of metabolic syndrome) and who are able to receive outpatient treatment.
  • A. Abdominal obesity: Waist circumference≥90cm(Male), 85cm(Female) B. Patients whose blood pressure ≥130/85mmHg(systolic blood pressure over 130 or, diastolic blood pressure over 85) or patients who are taking blood pressure medication.
  • C. Fasting Blood Glucose (FPG)≥ 100mg/dl. D. Patients whose triglyceride ≥150 mg/dl or patients who are taking fibrate. E. High-density lipoprotein cholesterol (HDL) \< 40 mg/dl (Male), 50 mg/dl(Female)
  • Patients who are able to understand the purpose of this trial and to read and write.
  • Patients who are able to use U-healthcare Smartphone for this trial.
  • Patients who participate voluntarily and sign the informed consent.

You may not qualify if:

  • Type I diabetes mellitus patients and type II diabetes mellitus patients requiring insulin therapy.
  • Patients currently being hospitalized or planning to hospitalize during the study period.
  • Patients were diagnosed with myocardial infarction or stroke within 1 year
  • End Stage Renal Disease patients requiring renal replacement therapy, Serum creatinine level is greater than 1.5 times the upper limit of normal.
  • Females who are pregnant
  • Hepatic failure (severe hepatic dysfunction). Liver Function Test (AST or ALT) is greater than 3 times the upper limit of normal.
  • Uncontrolled chronic lung disease.
  • Patients with known gallstone.
  • Patients who have cognitive disorder or psychiatric problems.
  • Patients who are taking anti-obesity medications such as Reductil, Xenical, etc., or patients are planning to receive the medications.
  • Patients who are taking Synthroid, diabetes medications or psychiatric medications which may affect on body weight.
  • Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
  • Patients who have participated in other clinical trial (except for the observational study) within 12 weeks prior to screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University Health System

Seoul, South Korea

Location

Related Publications (2)

  • Oh B, Yi GH, Han MK, Kim JS, Lee CH, Cho B, Kang HC. Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 3;6(1):e2. doi: 10.2196/mhealth.8719.

    PMID: 29298749DERIVED

  • Oh B, Cho B, Han MK, Choi H, Lee MN, Kang HC, Lee CH, Yun H, Kim Y. The Effectiveness of Mobile Phone-Based Care for Weight Control in Metabolic Syndrome Patients: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2015 Aug 20;3(3):e83. doi: 10.2196/mhealth.4222.

    PMID: 26293568DERIVED

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Bi-Ryong Cho

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Research Engineer

Study Record Dates

First Submitted

April 28, 2011

First Posted

April 29, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

KR(2)