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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Procedure: Telemonitoring; Other: control group

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.

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Smartcare System : Telemonitoring
Other: Control group; A weighing scale and Pedometer will be provided; recording in a self diary of body weight and the number of steps	Other: control group; 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 Names: Self Body Weight measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chang Hee, Lee
• Collaborators: Purdue University; LG Electronics Inc.
• Investigators: Principal Investigator: Bi-Ryong Cho, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Health Care Quality; Access; Evaluation; home care; telemonitoring; telehealth; usual care
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome
• Other Study ID Numbers: SmartCare-OB