Effects of Telemonitoring Service for Obesity Care

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

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.

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

Conditions
-----------------
Obesity, Metabolic Syndrome

Intervention / Treatment
-----------------
* Procedure: Telemonitoring
* Other: control group


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring group<br>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<br>* 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<br>* Other names: Smartcare System : Telemonitoring;|
| Other: Control group<br>A weighing scale and Pedometer will be provided recording in a self diary of body weight and the number of steps | Other: control group<br>* 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).<br>* Other names: Self Body Weight measurement;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change from Baseline to 24 weeks |  | 0 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) changes | Reduces of body mass index - BMI=Body weight (kg)/Height2(m) | 0 and 24 weeks | 
| Proportion of subjects whose body weight decreased more than 10% |  | 0 and 24 weeks | 
| Changes in body fat rate | Reduces in body fat rate | 0 and 24 weeks | 
| Changes in waist circumference | Reduces waist circumference | 0 and 24 weeks | 
| Changes in lipid profile | Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides) | 0 and 24 weeks | 
| Changes in blood pressure | Blood pressure value when hospital visiting Clinic blood pressure Changes in mean Blood Pressure from baseline to 24 weeks visit | 0 and 24 weeks | 
| Changes in prevalence rate of metabolic syndrome |  | 0 and 24 weeks | 
| Changes in the number of metabolic syndrome components | Reduce the number of metabolic syndrome components | 0 and 24 weeks | 
| Changes in lifestyle | Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc | 0 and 24 weeks | 
| Patients' satisfaction | applicable to Only Telemonitoring group | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemonitoring, usual care, telehealth, home care, Health Care Quality, Access, Evaluation