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| Name | Class |
|---|---|
| LG Electronics Inc. | INDUSTRY |
| Purdue University | OTHER |
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A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart Care Service in obese patients with metabolic syndrome.
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
Target Subject: Obese patients with metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | Experimental |
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| Control group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change from Baseline to 24 weeks | 0 and 24 weeks |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Bi-Ryong Cho | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea | ||||
| Yonsei University Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29298749 | Derived | Oh B, Yi GH, Han MK, Kim JS, Lee CH, Cho B, Kang HC. Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 3;6(1):e2. doi: 10.2196/mhealth.8719. | |
| 26293568 | Derived | Oh B, Cho B, Han MK, Choi H, Lee MN, Kang HC, Lee CH, Yun H, Kim Y. The Effectiveness of Mobile Phone-Based Care for Weight Control in Metabolic Syndrome Patients: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2015 Aug 20;3(3):e83. doi: 10.2196/mhealth.4222. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| 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). |
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| 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
| 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 |
| Seoul |
| South Korea |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D008722 | Methods |