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Effects of Telemonitoring Service for Obesity Care (Smart-OB)

This study has been completed.
Information provided by (Responsible Party):
Chang Hee, Lee, LG Electronics Inc. Identifier:
First received: April 28, 2011
Last updated: May 12, 2015
Last verified: May 2015
A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.

Condition Intervention
Metabolic Syndrome
Procedure: Telemonitoring
Other: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.

Resource links provided by NLM:

Further study details as provided by LG Electronics Inc.:

Primary Outcome Measures:
  • Weight Change from Baseline to 24 weeks [ Time Frame: 0 and 24 weeks ]

Secondary Outcome Measures:
  • Body Mass Index (BMI) changes [ Time Frame: 0 and 24 weeks ]

    Reduces of body mass index

    - BMI=Body weight (kg)/Height2(m)

  • Proportion of subjects whose body weight decreased more than 10% [ Time Frame: 0 and 24 weeks ]
  • Changes in body fat rate [ Time Frame: 0 and 24 weeks ]
    Reduces in body fat rate

  • Changes in waist circumference [ Time Frame: 0 and 24 weeks ]
    Reduces waist circumference

  • Changes in lipid profile [ Time Frame: 0 and 24 weeks ]
    Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)

  • Changes in blood pressure [ Time Frame: 0 and 24 weeks ]

    Blood pressure value when hospital visiting

    • Clinic blood pressure
    • Changes in mean Blood Pressure from baseline to 24 weeks visit

  • Changes in prevalence rate of metabolic syndrome [ Time Frame: 0 and 24 weeks ]
  • Changes in the number of metabolic syndrome components [ Time Frame: 0 and 24 weeks ]
    Reduce the number of metabolic syndrome components

  • Changes in lifestyle [ Time Frame: 0 and 24 weeks ]
    Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc

  • Patients' satisfaction [ Time Frame: 24 weeks ]
    applicable to Only Telemonitoring group

Enrollment: 661
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemonitoring group
  • 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
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
Other Name: Smartcare System : Telemonitoring
Control group
  • A weighing scale and Pedometer will be provided
  • recording in a self diary of body weight and the number of steps
Other: control group
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).
Other Name: Self Body Weight measurement

Detailed Description:
  1. Objectives : To evaluate superiority of U(Ubiquitous)-Healthcare(hereinafter referred to as Smart Care) Service being combined conventional treatment with health care service, in comparison to conventional treatment in obese patients with metabolic syndrome.
  2. Test and control group

    • Test groups : The subject group who is receiving health care services using conventional treatment (hospital visit) and Smart Care Service (Telemonitoring).
    • Control group : The subject group who is receiving conventional treatment (hospital visit).
  3. Target Subject: Obese patients with metabolic syndrome.

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age: More than 20 years of age and under 70 years of age.
  2. BMI ≥ 25kg/m2
  3. 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)

  4. Patients who are able to understand the purpose of this trial and to read and write.
  5. Patients who are able to use U-healthcare Smartphone for this trial.
  6. Patients who participate voluntarily and sign the informed consent.

Exclusion Criteria:

  1. Type I diabetes mellitus patients and type II diabetes mellitus patients requiring insulin therapy.
  2. Patients currently being hospitalized or planning to hospitalize during the study period.
  3. Patients were diagnosed with myocardial infarction or stroke within 1 year
  4. End Stage Renal Disease patients requiring renal replacement therapy, Serum creatinine level is greater than 1.5 times the upper limit of normal.
  5. Females who are pregnant
  6. Hepatic failure (severe hepatic dysfunction). Liver Function Test (AST or ALT) is greater than 3 times the upper limit of normal.
  7. Uncontrolled chronic lung disease.
  8. Patients with known gallstone.
  9. Patients who have cognitive disorder or psychiatric problems.
  10. Patients who are taking anti-obesity medications such as Reductil, Xenical, etc., or patients are planning to receive the medications.
  11. Patients who are taking Synthroid, diabetes medications or psychiatric medications which may affect on body weight.
  12. 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.
  13. Patients who have participated in other clinical trial (except for the observational study) within 12 weeks prior to screening visit.
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Please refer to this study by its identifier: NCT01344811

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Yonsei University Health System
Seoul, Korea, Republic of
Sponsors and Collaborators
Chang Hee, Lee
Principal Investigator: Bi-Ryong Cho Seoul National University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chang Hee, Lee, Chief Research Engineer, LG Electronics Inc. Identifier: NCT01344811     History of Changes
Other Study ID Numbers: SmartCare-OB
Study First Received: April 28, 2011
Last Updated: May 12, 2015

Keywords provided by LG Electronics Inc.:
usual care
home care
Health Care Quality

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 22, 2017