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

29. januar 2020 oppdatert av: Chang Hee, Lee

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  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.

Studietype

Intervensjonell

Registrering (Faktiske)

661

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken
        • Seoul National University Hospital
      • Seoul, Korea, Republikken
        • Yonsei University Health System

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Fremgangsmåte: 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
Andre navn:
  • Smartcare System : Telemonitorering
Annen: Control group
  • A weighing scale and Pedometer will be provided
  • recording in a self diary of body weight and the number of steps
Annen: 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).
Andre navn:
  • Self Body Weight measurement

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Weight Change from Baseline to 24 weeks
Tidsramme: 0 and 24 weeks
0 and 24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body Mass Index (BMI) changes
Tidsramme: 0 and 24 weeks

Reduces of body mass index

- BMI=Body weight (kg)/Height2(m)
0 and 24 weeks
Proportion of subjects whose body weight decreased more than 10%
Tidsramme: 0 and 24 weeks
0 and 24 weeks
Changes in body fat rate
Tidsramme: 0 and 24 weeks
Reduces in body fat rate
0 and 24 weeks
Changes in waist circumference
Tidsramme: 0 and 24 weeks
Reduces waist circumference
0 and 24 weeks
Changes in lipid profile
Tidsramme: 0 and 24 weeks
Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)
0 and 24 weeks
Changes in blood pressure
Tidsramme: 0 and 24 weeks

Blood pressure value when hospital visiting

  • Clinic blood pressure
  • Changes in mean Blood Pressure from baseline to 24 weeks visit
0 and 24 weeks
Changes in prevalence rate of metabolic syndrome
Tidsramme: 0 and 24 weeks
0 and 24 weeks
Changes in the number of metabolic syndrome components
Tidsramme: 0 and 24 weeks
Reduce the number of metabolic syndrome components
0 and 24 weeks
Changes in lifestyle
Tidsramme: 0 and 24 weeks
Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc
0 and 24 weeks
Patients' satisfaction
Tidsramme: 24 weeks
applicable to Only Telemonitoring group
24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Hee, Lee

Samarbeidspartnere

Purdue University
LG Electronics Inc.

Etterforskere

  • Hovedetterforsker: Bi-Ryong Cho, Seoul National University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2011

Primær fullføring (Faktiske)

1. mars 2013

Studiet fullført (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først innsendt

28. april 2011

Først innsendt som oppfylte QC-kriteriene

28. april 2011

Først lagt ut (Anslag)

29. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. januar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SmartCare-OB

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Legemiddelintervensjoner

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Forhold

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