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A pilot study of severe obesity intervention based on Community Care (office of education - public health center - hospital)

Status Approved

  • First Submitted Date

    2019/07/08

  • Registered Date

    2019/07/12

  • Last Updated Date

    2019/07/12

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
    KCT0004137
    Unique Protocol ID HALLYM 2019-04-027-002
    Public/Brief Title A pilot study of severe obesity intervention based on Community Care (office of education - public health center - hospital)
    Scientific Title A pilot study of severe obesity intervention based on Community Care (office of education - public health center - hospital)
    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 HALLYM 2019-04-027-002
    Approval Date 2019-06-24
    Institutional Review Board Name Hallym University Sacred Heart Hospital Institutional Review Board
    Institutional Review Board Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
    Institutional Review Board Telephone 031-380-1975
    Data Monitoring Committee
  • 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 Kyung Hee Park
    Title Professor
    Telephone +82-31-383-3179
    Affiliation Hallym University Medical Center
    Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
    Contact Person for Public Queries
    Name Sarah Woo
    Title Research engineer
    Telephone +82-31-383-3179
    Affiliation Hallym University Medical Center
    Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
    Contact Person for Updating Information
    Name Sarah Woo
    Title Research engineer
    Telephone +82-31-383-3179
    Affiliation Hallym University Medical Center
    Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
  • 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 : 3
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-07-15 Anticipated
    Target Number of Participant 300
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Hallym University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-07-15 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Yonsei University
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-07-15 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Kyung Hee University
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-07-15 ,
  • 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 Korea Centers for Disease Control and Prevention
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hallym University Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study is to develop and implement a protocol for application of the obesity intervention program in a community setting, which was developed in the 'Long term follow-up intervention study of morbid obese children and adolescents' study. Accordingly, we intend to establish a networking system with the local community organizations including the educational government, public health centers, and local medical institutions to develop a standard protocol for the intervention, implement pilot programs, and present final guidelines. For this purpose, we intend to investigate the effectiveness of the 12-month lifestyle modification intervention for obese children and adolescents where community medical institutions, public health centers, and education offices participate together in a community care setting.
  • 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 Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Behavioral  
    Intervention Description
    For lifestyle modification, a 12-month intervention program is implemented to all participants (single group intervention): 1:1 nutrition counseling (5 times), behavioral modification counseling (10 times) and exercise program (34 times)
    Number of Arms 1
    Arm 1

    Arm Label

    Standard Care group

    Target Number of Participant

    300

    Arm Type

    Experimental

    Arm Description

    For lifestyle modification, a 12-month intervention program is implemented to all participants (single group intervention): 1:1 nutrition counseling (5 times), behavioral modification counseling (10 times) and exercise program (34 times)
  • 9. Subject Eligibility

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

    pediatric obesity
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    10Year~14Year

    Description

    Obese individuals aged 10-14 (Obesity inclusion criteria : age and sex specific BMI over 97 percentile according to 2017 Korean National Growth Chart
    Exclusion Criteria
    A physical disability that does not allow participation in the exercise program; BMI score that does not meet the inclusion criteria
    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 Efficacy
    Primary Outcome(s) 1
    Outcome
    BMI Z score, %BMI95th
    Timepoint
    Baseline, 6 month follow-up, 12 month follow-up
    Secondary Outcome(s) 1
    Outcome
    Body composition (body fat percentage, body fat mass, body fat-free mass, FMI, FFMI), waist circumference
    Timepoint
    Baseline, 6 month follow-up, 12 month follow-up
    Secondary Outcome(s) 2
    Outcome
    Metabolic and cardiovascular risk markers (Liver function(AST/ALT/GGT), dyslipidemia (HDL, LDL, TG), insulin resistance/FBS, blood pressure), other metabolic disease related biomarkers(acanthosis nigricans, etc)
    Timepoint
    Baseline, 6 month follow-up, 12 month follow-up
    Secondary Outcome(s) 3
    Outcome
    Body strength related markers (physical activity, cardiorespiratory endurance, muscle strength)
    Timepoint
    Baseline, 6 month follow-up, 12 month follow-up
    Secondary Outcome(s) 4
    Outcome
    Nutritional index (energy intake, food addiction, eating behavior, etc.)
    Timepoint
    Baseline, 6 month follow-up, 12 month follow-up
    Secondary Outcome(s) 5
    Outcome
    Psychological index (depression, problem behaviors, family functioning, etc.) and lifestyle behaviors (sleep pattern, intervention adherence, etc.)
    Timepoint
    Baseline, 6 month follow-up, 12 month 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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