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
Recruitment status was Recruiting
Sponsor:
LG Electronics Inc.
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
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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
|
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
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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 June 18, 2013