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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by LG Electronics Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LG Electronics Inc.
ClinicalTrials.gov Identifier:
NCT01344811
First received: April 28, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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


Condition Intervention
Obesity
Metabolic Syndrome
Procedure: Telemonitoring
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Mass Index (BMI) changes [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Changes in body fat rate [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
    Reduces in body fat rate

  • Changes in waist circumference [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
    Reduces waist circumference

  • Changes in lipid profile [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
    Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)

  • Changes in blood pressure [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Changes in the number of metabolic syndrome components [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
    Reduce the number of metabolic syndrome components

  • Changes in lifestyle [ Time Frame: 0 and 24 weeks ] [ Designated as safety issue: No ]
    Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc

  • Patients' satisfaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    applicable to Only Telemonitoring group


Estimated Enrollment: 446
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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
No Intervention: Control group
  • A weighing scale and Pedometer will be provided
  • recording in a self diary of body weight and the number of steps
Other: Usual Care
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.
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344811

Contacts
Contact: Jeongweon Park 82-10-2357-0538 Jeongweon.Park@lge.com
Contact: Youngdon Hwang 82-10-7575-0406 youngdon.hwang@lge.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bi-Ryong Cho    82-2-2072-2195    belong@snu.ac.kr   
Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Hui-Chol Kang    82-2-2228-5760    kanghc@yuhs.ac   
Sponsors and Collaborators
LG Electronics Inc.
Investigators
Principal Investigator: Bi-Ryong Cho Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Youngdon Hwang/Chief Research Engineer, LG Electronics Inc.
ClinicalTrials.gov Identifier: NCT01344811     History of Changes
Other Study ID Numbers: SmartCare-OB
Study First Received: April 28, 2011
Last Updated: April 28, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by LG Electronics Inc.:
telemonitoring
usual care
telehealth
home care
Health Care Quality
Access
Evaluation

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014