Effects of Telemonitoring Service for Obesity Care

NCT ID: NCT01344811

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 661 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-06-30

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.

Conditions

Obesity; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Telemonitoring

Intervention Type: PROCEDURE

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

Control group

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

Group Type: OTHER

control group

Intervention Type: OTHER

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).

Interventions

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

Intervention Type: PROCEDURE

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).

Intervention Type: OTHER

Other Intervention Names

Smartcare System : Telemonitoring; Self Body Weight measurement

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Electronics Inc.

INDUSTRY

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

Chang Hee, Lee

INDUSTRY

Sponsor Role: lead

Responsible Party

Chang Hee, Lee

Chief Research Engineer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bi-Ryong Cho

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Yonsei University Health System

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29298749 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26293568 (View on PubMed)

Other Identifiers

SmartCare-OB

Identifier Type: -

Identifier Source: org_study_id