Smart-OB: Effects of Telemonitoring Service for Obesity Care

Sponsor

Chang Hee, Lee (Industry)

Overall Status

Completed

CT.gov ID

NCT01344811

Collaborator

LG Electronics Inc. (Industry), Purdue University (Other)

661

Enrollment

Locations

Arms

Duration (Months)

330.5

Patients Per Site

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Metabolic Syndrome	Procedure: Telemonitoring Other: control group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

661 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Weight Change from Baseline to 24 weeks [0 and 24 weeks]

Secondary Outcome Measures

Body Mass Index (BMI) changes [0 and 24 weeks]
Reduces of body mass index - BMI=Body weight (kg)/Height2(m)
Proportion of subjects whose body weight decreased more than 10% [0 and 24 weeks]
Changes in body fat rate [0 and 24 weeks]
Reduces in body fat rate
Changes in waist circumference [0 and 24 weeks]
Reduces waist circumference
Changes in lipid profile [0 and 24 weeks]
Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)
Changes in blood pressure [0 and 24 weeks]
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 [0 and 24 weeks]
Changes in the number of metabolic syndrome components [0 and 24 weeks]
Reduce the number of metabolic syndrome components
Changes in lifestyle [0 and 24 weeks]
Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc
Patients' satisfaction [24 weeks]
applicable to Only Telemonitoring group

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.
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.