A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
661
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
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).
Seoul National University Hospital
Seoul, South Korea
Yonsei University Health System
Seoul, South Korea
Weight Change from Baseline to 24 weeks
Time frame: 0 and 24 weeks
Body Mass Index (BMI) changes
Reduces of body mass index \- BMI=Body weight (kg)/Height2(m)
Time frame: 0 and 24 weeks
Proportion of subjects whose body weight decreased more than 10%
Time frame: 0 and 24 weeks
Changes in body fat rate
Reduces in body fat rate
Time frame: 0 and 24 weeks
Changes in waist circumference
Reduces waist circumference
Time frame: 0 and 24 weeks
Changes in lipid profile
Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)
Time frame: 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
Time frame: 0 and 24 weeks
Changes in prevalence rate of metabolic syndrome
Time frame: 0 and 24 weeks
Changes in the number of metabolic syndrome components
Reduce the number of metabolic syndrome components
Time frame: 0 and 24 weeks
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Changes in lifestyle
Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc
Time frame: 0 and 24 weeks
Patients' satisfaction
applicable to Only Telemonitoring group
Time frame: 24 weeks