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
CRIS Registration Number |
KCT0004582 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Hotel Shilla |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hotel Shilla |
Organization Type | Others |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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