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

Chang Hee, Lee

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Treatments: Other: control group; Procedure: Telemonitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01344811

SmartCare-OB

Details and patient eligibility

About

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

Full 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.

Enrollment: 661 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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661 participants in 2 patient groups

Telemonitoring group

Experimental group

Description:

* 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

Treatment:

Procedure: Telemonitoring

Control group

Other group

Description:

* A weighing scale and Pedometer will be provided * recording in a self diary of body weight and the number of steps

Treatment:

Other: control group