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Development of lifestyle modification program using ICT for obese polycystic ovary syndrome patients

Status Approved

  • First Submitted Date

    2021/03/27

  • Registered Date

    2021/04/07

  • Last Updated Date

    2021/12/07

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    		 KCT0006062
    Unique Protocol ID NRF-2020R1F1A1073141
    Public/Brief Title Development of lifestyle modification program using ICT for obese polycystic ovary syndrome patients
    Scientific Title Development of lifestyle modification program using ICT for obese polycystic ovary syndrome patients
    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 1044396-202010-HR-192-02
    Approval Date 2021-03-12
    Institutional Review Board Name Gachon University Institutional Review Board
    Institutional Review Board Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-750-8566
    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 Seon Heui Lee
    Title Prof.
    Telephone +82-32-820-4230
    Affiliation Gachon University
    Address 191, Hambangmoe-ro, Yeonsu-gu, Incheon, Republic of Korea
    Contact Person for Public Queries
    Name Hee Kyung Choi
    Title Ms.
    Telephone +82-32-820-4230
    Affiliation Gachon University
    Address 191, Hambangmoe-ro, Yeonsu-gu, Incheon, Republic of Korea
    Contact Person for Updating Information
    Name Hee Kyung Choi
    Title Ms.
    Telephone +82-32-820-4230
    Affiliation Gachon University
    Address 191, Hambangmoe-ro, Yeonsu-gu, Incheon, Republic of Korea

  • 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 Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-10-25 Actual
    Target Number of Participant 30
    Primary Completion Date 2023-02-28 , Anticipated
    Study Completion Date 2023-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2021-10-25 ,

  • 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 National Research Foundation
    Organization Type Government
    Project ID NRF-2020R1F1A1073141

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Gachon University
    Organization Type University

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Polycystic ovarian syndrome is the most common cause of anovulatory infertility and is an important issue with women's health. The most basic and important treatment for patients with obesity polycystic ovarian syndrome is to maintain a healthy lifestyle.  The lifestyle modification program of the previous study has various and heterogeneous problems, so it is necessary to develop a lifestyle modification program through systematic review. In addition, the lifestyle modification program of previous study is limited to diet and exercise therapy, so it is necessary to develop a customized lifestyle modification program that allows comprehensive intervention. Finally, to improve the low implementation rate of lifestyle modification programs, we want to develop and apply interventions using ICT.

  • 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 
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject, Outcome Accessor
    Allocation RCT
    Intervention Type Others  
    Intervention Description 
    Experimental group
- We provide lifestyle modification programs using ICT for 12 weeks.
- Every day, participants report lifestyle (diet, steps per day, body weight, height) and gynecological symptoms (hirsutism, acne, menstrual cycle). 
- Feedback is provided twice a week via SNS or phone. 
- Participants visit the center once a month for consultation.

Control group
- Usual care
- Provide Leaflet
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    - We provide lifestyle modification programs using ICT for 12 weeks.
- Every day, participants report lifestyle (diet, steps per day, body weight, height) and gynecological symptoms (hirsutism, acne, menstrual cycle). 
- Feedback is provided twice a week via SNS or phone. 
- Participants visit the center once a month for consultation.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    15

    Arm Type

    Others

    Arm Description

    - Usual care
- Provide Leaflet

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E28.2)Polycystic ovarian syndrome 

    Polycystic ovarian syndrome
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    No Limit~No Limit

    Description

    1. Patients with obesity polycystic ovarian syndrome (BMI≥23)
2. Those who can use computers and cell phones
3. A person who understands and agrees to participate in the research
    Exclusion Criteria 
    1. Pregnant
2. Patients with endocrine abnormalities
3. A person who takes a drug that reduces insulin resistance
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome 
    Physical indicators (weight, blood pressure)
    Timepoint 
    Baseline, after 12 weeks
    Primary Outcome(s) 2
    Outcome 
    Productivity indicators (menstrual cycle, pregnancy status)
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 1
    Outcome 
    Hormone indicators (Basal hormone(LH, FSH, E2), Androgenic hormone (TT, SHBG, DHEAS))
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 2
    Outcome 
    Insulin resistance indicators (glucose, insulin)
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 3
    Outcome 
    Hirsutism (Ferriman-Gallwey Score)
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 4
    Outcome 
    Acne  (Global Acne Grading System)
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 5
    Outcome 
    Depression (K-CESD)
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 6
    Outcome 
    Mobile App Rating Sclae (MARS)
    Timepoint 
    Baseline, after 12 weeks
    Secondary Outcome(s) 7
    Outcome 
    Program satisfaction
    Timepoint 
    Baseline, after 12 weeks

  • 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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