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The effectiveness of SHP Program for the Improvement of Cardiovascular Risk Factors in Metabolic Syndrome Patients : A Multicenter, Randomized, Controlled Trial

Status Approved

  • First Submitted Date

    2019/12/11

  • Registered Date

    2019/12/24

  • Last Updated Date

    2020/03/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004582
    Unique Protocol ID KBSMC 2019-08-010-002
    Public/Brief Title The effectiveness of SHP Program for the Improvement of Cardiovascular Risk Factors in Metabolic Syndrome Patients : A Multicenter, Randomized, Controlled Trial
    Scientific Title The effectiveness of SHP Program for the Improvement of Cardiovascular Risk Factors in Metabolic Syndrome Patients : A Multicenter, Randomized, Controlled Trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KBSMC 2019-08-010-002
    Approval Date 2019-11-15
    Institutional Review Board Name Kangbuk Samsung Hospital Institutional Review Board
    Institutional Review Board Address 29, Saemunan-ro, Jongno-gu, Seoul
    Institutional Review Board Telephone 02-2001-2709
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Eunju Sung
    Title Professor
    Telephone +82-2-2001-1790
    Affiliation Kangbuk Samsung Medical Center
    Address 29, Saemunan-ro, Jongno-gu, Seoul
    Contact Person for Public Queries
    Name Jihyun Nam
    Title Researcher
    Telephone +82-2-2001-1971
    Affiliation Kangbuk Samsung Medical Center
    Address 29, Saemunan-ro, Jongno-gu, Seoul
    Contact Person for Updating Information
    Name Hyungseok Oh
    Title Assistant professor
    Telephone +82-2-3486-2063
    Affiliation Kangbuk Samsung Medical Center
    Address 29, Saemunan-ro, Jongno-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-02 Anticipated
    Target Number of Participant 300
    Primary Completion Date 2020-05-29 , Anticipated
    Study Completion Date 2020-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Electronics Seoul R&D Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-02 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Samsung Electro-Mechanics Suwon Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-02 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hotel Shilla
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hotel Shilla
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    •Young employees have lower rates of chronic disease than older people. However, their perception, treatment rate, and control rates for their disease are about half that of the elderly.
    •In the previous study, we observed the results of improving obesity, diabetes, metabolic syndrome using mobile. In some cases, the effectiveness of workplace health care programs was confirmed, but most of them were fragmented health care services.
    •In addition, there is a lack of research data on the effects of systematic health management programs integrating online and offline.
    •Therefore, we aim to verify the improvement of cardiovascular risk factors (metabolism syndrome, obesity) using SHP online and offline integration program.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others  
    Intervention Description
    •We will divide the subjects enrolled by the inclusion and exclusion criteria into three groups.
    •We will randomize subjects in the same proportions to Intervention Group 1 (Basic Healthcare Program + Mobile Application), Intervention Group 2 (Basic Healthcare Program + Mobile + SHP Offline Service) and Control Group (Basic Healthcare Program).
    Number of Arms 2
    Arm 1

    Arm Label

    Intervention group 1

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    Providing online coaching services through SHP applications
    Arm 2

    Arm Label

    Intervention group 2

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    Providing online coaching services through SHP applications and group exercise (additional offline intervention)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 

    1. Obesity (bmi 25 kg/m2 and over) 2. Metabolic syndrome
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~No Limit

    Description

    1) Age: over 20 years old
    2) body mass index (BMI) ≥ 25 kg / m2
    3) Metabolic Syndrome
            * Those who meet 3 or more of the following 5 elements 
            (1) abdominal obesity: waist ≥ 90 cm (male), 85 cm (female)
            (2) blood pressure ≥ 130/85 mmHg
            (3) fasting blood sugar ≥ 100 mg / dL
            (4) triglyceride ≥ 150 mg / dL  or Patients taking fibrate medications
            (5) high-density lipoprotein cholesterol (HDL-C) <40 mg /dL (male), 50 mg /dL (Female)
    4) Patients who can understand, read, and write the purpose of clinical research
    5) Patients who can use the smartphone application used for clinical research
    6) Patients who voluntarily participate and sign a consent form
    Exclusion Criteria
    1) Participants in a diet or weight loss healthcare program within 12 weeks prior to the screening visit
    2) Patients who are currently in hospital or are expected to need hospitalization within the clinical study period
    3) Patients diagnosed with myocardial infarction or stroke within the last year
    4) Patients with end stage renal failure who need renal replacement therapy
       Serum creatine levels are more than 1.5 times the upper limit of normal
    5) Pregnant women
    6) Liver Failure (Severe Liver Disorder Patients)
        Serum liver enzyme (AST or ALT) is more than five times the upper limit of normal
    7) Uncontrolled chronic lung disease
    8) Phentermin, orlistat 등 항비만약물 치료 중이거나 예정인 환자
    9) Patients taking drugs that may affect their weight (eg psychiatric drugs)
    10) Patients who have a medical condition that is likely to affect clinical research results, such as clinically significant neurological disease, gastrointestinal disease, or malignant tumor, or are inappropriate for participation in clinical research, as judged by the investigator.
    11) Participants in other clinical studies (excluding observational studies) within 12 weeks before the screening visit
    12) Type I and Type II Diabetics requiring Insulin Treatment
    13) Participants who have had a weight change of more than 10% of their weight in the last year
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Changes in body weight, body mass index, and metabolic syndrome prevalence
    Timepoint
    after 12 weeks from baseline and 1-year follow-up
    Secondary Outcome(s) 1
    Outcome
    Test results and lifestyle changes related to obesity and metabolic syndrome, including blood pressure, serum lipids, liver function, uric acid, blood sugar, and insulin resistance
    Timepoint
    after 12 weeks from baseline and 1-year follow-up
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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