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ObesitySmart-OBNCT01344811

Effects of Telemonitoring Service for Obesity Care

A study testing Telemonitoring in people with Obesity and Metabolic Syndrome, run by Chang Hee, Lee at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Obesity, Metabolic Syndrome
What is being tested?
Telemonitoring
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
661 participants
Where
2 sitesSouth Korea
Study dates
Jan 2011to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Hospital

    Seoul

  • Yonsei University Health System

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.

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

Read the 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).
  1. Target Subject: Obese patients with metabolic syndrome.
Being tested
Telemonitoring, control group
Keywords
telemonitoring, usual care, telehealth, home care, Health Care Quality, Access, Evaluation
Medical subject headings
Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemonitoringProcedure or surgery

    Also called Smartcare System : 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

  • control groupOther

    Also called Self Body Weight measurement

    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).

Study groups in NCT01344811
Study groupRoleWhat they receive
Telemonitoring groupExperimental* 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
Receives: Procedure: Telemonitoring
Control groupOther* A weighing scale and Pedometer will be provided * recording in a self diary of body weight and the number of steps
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change from Baseline to 24 weeks

    Measured: 0 and 24 weeks

Secondary outcomes (10)

  1. Body Mass Index (BMI) changes

    Reduces of body mass index

    • BMI=Body weight (kg)/Height2(m)

    Measured: 0 and 24 weeks

  2. Proportion of subjects whose body weight decreased more than 10%

    Measured: 0 and 24 weeks

  3. Changes in body fat rate

    Reduces in body fat rate

    Measured: 0 and 24 weeks

  4. Changes in waist circumference

    Reduces waist circumference

    Measured: 0 and 24 weeks

  5. Changes in lipid profile

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

    Measured: 0 and 24 weeks

  6. Changes in blood pressure

    Blood pressure value when hospital visiting

    • Clinic blood pressure
    • Changes in mean Blood Pressure from baseline to 24 weeks visit

    Measured: 0 and 24 weeks

  7. Changes in prevalence rate of metabolic syndrome

    Measured: 0 and 24 weeks

  8. Changes in the number of metabolic syndrome components

    Reduce the number of metabolic syndrome components

    Measured: 0 and 24 weeks

  9. Changes in lifestyle

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

    Measured: 0 and 24 weeks

  10. Patients' satisfaction

    applicable to Only Telemonitoring group

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
661 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01344811
Sponsor's protocol ID
SmartCare-OB
Acronym
Smart-OB
Status last verified
Jan 2020
First submitted
28 Apr 2011
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29298749

  • 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.

    PubMed 26293568

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring in people with Obesity and Metabolic Syndrome, run by Chang Hee, Lee at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change from Baseline to 24 weeks (time frame: 0 and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01344811, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

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