Clinical trial NCT01344811: Effects of Telemonitoring Service for Obesity Care
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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: telemonitoring
usual care
telehealth
home care
Health Care Quality
Access
Evaluation
Lead sponsor: LG Electronics Inc.
Sponsor class: INDUSTRY
Collaborators: name: LG Electronics Inc.
name: Purdue University
First posted: 2011-04-29
Enrollment: 661
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Weight Change from Baseline to 24 weeks
timeFrame: 0 and 24 weeks
Secondary outcomes:
measure: Body Mass Index (BMI) changes
timeFrame: 0 and 24 weeks
measure: Proportion of subjects whose body weight decreased more than 10%
timeFrame: 0 and 24 weeks
measure: Changes in body fat rate
timeFrame: 0 and 24 weeks
measure: Changes in waist circumference
timeFrame: 0 and 24 weeks
measure: Changes in lipid profile
timeFrame: 0 and 24 weeks
measure: Changes in blood pressure
timeFrame: 0 and 24 weeks
measure: Changes in prevalence rate of metabolic syndrome
timeFrame: 0 and 24 weeks
measure: Changes in the number of metabolic syndrome components
timeFrame: 0 and 24 weeks
measure: Changes in lifestyle
timeFrame: 0 and 24 weeks
measure: Patients' satisfaction
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
Study officials:
affiliation: Seoul National University Hospital
name: Bi-Ryong Cho
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.