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

Primary Purpose

Obesity, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Telemonitoring

control group

About this trial

This is an interventional supportive care trial for Obesity focused on measuring telemonitoring, usual care, telehealth, home care, Health Care Quality, Access, Evaluation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.
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)
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.

Sites / Locations

Seoul National University Hospital
Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Telemonitoring group

Control group

Arm 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

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

Outcomes

Primary Outcome Measures

Weight Change from Baseline to 24 weeks

Secondary Outcome Measures

Body Mass Index (BMI) changes

Reduces of body mass index - BMI=Body weight (kg)/Height2(m)

Proportion of subjects whose body weight decreased more than 10%

Changes in body fat rate

Reduces in body fat rate

Changes in waist circumference

Reduces waist circumference

Changes in lipid profile

Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)

Changes in blood pressure

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

Changes in the number of metabolic syndrome components

Reduce the number of metabolic syndrome components

Changes in lifestyle

Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc

Patients' satisfaction

applicable to Only Telemonitoring group

Full Information

NCT ID

NCT01344811

First Posted

April 28, 2011

Last Updated

January 29, 2020

Sponsor

Chang Hee, Lee

Collaborators

LG Electronics Inc., Purdue University

1. Study Identification

Unique Protocol Identification Number

NCT01344811

Brief Title

Effects of Telemonitoring Service for Obesity Care

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chang Hee, Lee

Collaborators

LG Electronics Inc., Purdue University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome

Keywords

telemonitoring, usual care, telehealth, home care, Health Care Quality, Access, Evaluation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

661 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telemonitoring group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Telemonitoring

Other Intervention Name(s)

Smartcare System : Telemonitoring

Intervention Description

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

Other

Intervention Name(s)

control group

Other Intervention Name(s)

Self Body Weight measurement

Intervention Description

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).

Primary Outcome Measure Information:

Title

Weight Change from Baseline to 24 weeks

Time Frame

0 and 24 weeks

Secondary Outcome Measure Information:

Title

Body Mass Index (BMI) changes

Description

Reduces of body mass index - BMI=Body weight (kg)/Height2(m)

Time Frame

0 and 24 weeks

Title

Proportion of subjects whose body weight decreased more than 10%

Time Frame

0 and 24 weeks

Title

Changes in body fat rate

Description

Reduces in body fat rate

Time Frame

0 and 24 weeks

Title

Changes in waist circumference

Description

Reduces waist circumference

Time Frame

0 and 24 weeks

Title

Changes in lipid profile

Description

Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)

Time Frame

0 and 24 weeks

Title

Changes in blood pressure

Description

Blood pressure value when hospital visiting Clinic blood pressure Changes in mean Blood Pressure from baseline to 24 weeks visit

Time Frame

0 and 24 weeks

Title

Changes in prevalence rate of metabolic syndrome

Time Frame

0 and 24 weeks

Title

Changes in the number of metabolic syndrome components

Description

Reduce the number of metabolic syndrome components

Time Frame

0 and 24 weeks

Title

Changes in lifestyle

Description

Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc

Time Frame

0 and 24 weeks

Title

Patients' satisfaction

Description

applicable to Only Telemonitoring group

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bi-Ryong Cho

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Yonsei University Health System

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

29298749

Citation

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.

Results Reference

derived

PubMed Identifier

26293568

Citation

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.

Results Reference

derived

Learn more about this trial

Effects of Telemonitoring Service for Obesity Care

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