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OpenTrials
Completed

NCT Number: NCT01344811

Effects of Telemonitoring Service for Obesity Care

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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital, Seoul, South Korea

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About this study

  • 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.
  • 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).
  • Target Subject: Obese patients with metabolic syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Telemonitoring

Procedure

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 names: Smartcare System : Telemonitoring

Control Group

Other

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 names: Self Body Weight measurement

Primary outcomes

  1. Weight Change from Baseline to 24 weeks

    Time frame: 0 and 24 weeks

Secondary outcomes

  1. Body Mass Index (BMI) changes

    Time frame: 0 and 24 weeks

    Reduces of body mass index

    • BMI=Body weight (kg)/Height2(m)
  2. Proportion of subjects whose body weight decreased more than 10%

    Time frame: 0 and 24 weeks

  3. Changes in body fat rate

    Time frame: 0 and 24 weeks

    Reduces in body fat rate

  4. Changes in waist circumference

    Time frame: 0 and 24 weeks

    Reduces waist circumference

  5. Changes in lipid profile

    Time frame: 0 and 24 weeks

    Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)

  6. 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
  7. Changes in prevalence rate of metabolic syndrome

    Time frame: 0 and 24 weeks

  8. Changes in the number of metabolic syndrome components

    Time frame: 0 and 24 weeks

    Reduce the number of metabolic syndrome components

  9. Changes in lifestyle

    Time frame: 0 and 24 weeks

    Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc

  10. Patients' satisfaction

    Time frame: 24 weeks

    applicable to Only Telemonitoring group

Sponsors and collaborators

Lead sponsor

Chang Hee, Lee

Industry

Collaborators

  • LG Electronics Inc.
  • Purdue University

Registry information

Official study title

A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.

Acronym: Smart-OB

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2011
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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