Effects of Telemonitoring Service for Obesity Care

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Other: control group; Procedure: Telemonitoring

• Registration Number: NCT01344811
• Lead Sponsor: Chang Hee, Lee

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 661

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	control group	* A weighing scale and Pedometer will be provided * recording in a self diary of body weight and the number of steps
Telemonitoring group	Telemonitoring	* 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

Primary Outcome Measures

Name	Time	Method
Weight Change from Baseline to 24 weeks	0 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in lifestyle	0 and 24 weeks	Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc
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 the number of metabolic syndrome components	0 and 24 weeks	Reduce the number of metabolic syndrome components
Body Mass Index (BMI) changes	0 and 24 weeks	Reduces of body mass index; - BMI=Body weight (kg)/Height2(m)
Changes in waist circumference	0 and 24 weeks	Reduces waist circumference
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
Patients' satisfaction	24 weeks	applicable to Only Telemonitoring group
Changes in lipid profile	0 and 24 weeks	Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of