Effects of Telemonitoring Service for Obesity Care

Obesity Clinical Trial

— Smart-OB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344811
• Other study ID #: SmartCare-OB
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2020
• Source: LG Electronics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

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:
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Health System	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Chang Hee, Lee	JAEBIN, LEE / Statistics - Math Emphasis in Purdue University, YOON SOOK, KIM / Chief Research Engineer in LG Electronics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change from Baseline to 24 weeks		0 and 24 weeks
Secondary	Body Mass Index (BMI) changes	Reduces of body mass index; - BMI=Body weight (kg)/Height2(m)	0 and 24 weeks
Secondary	Proportion of subjects whose body weight decreased more than 10%		0 and 24 weeks
Secondary	Changes in body fat rate	Reduces in body fat rate	0 and 24 weeks
Secondary	Changes in waist circumference	Reduces waist circumference	0 and 24 weeks
Secondary	Changes in lipid profile	Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)	0 and 24 weeks
Secondary	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
Secondary	Changes in prevalence rate of metabolic syndrome		0 and 24 weeks
Secondary	Changes in the number of metabolic syndrome components	Reduce the number of metabolic syndrome components	0 and 24 weeks
Secondary	Changes in lifestyle	Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc	0 and 24 weeks
Secondary	Patients' satisfaction	applicable to Only Telemonitoring group	24 weeks