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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2019/07/08
    • Registered Date : 2019/07/12
    • Last Updated Date : 2019/07/12
Background Information
1.Background  
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
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 
- Telephone 031-380-1975 
Data Monitoring Committee    
Contact Details
3.Contact Details  
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 
Status
4. Status Status  
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 Site Hallym University Medical Center 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-07-15 , Anticipated
Recruitment Status by Participating Study Site 2 
- Name of Study Site Yonsei University 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-07-15 , Anticipated
Recruitment Status by Participating Study Site 3 
- Name of Study Site Kyung Hee University 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-07-15 , Anticipated
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Korea Centers for Disease Control and Prevention 
- Organization Type Government  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Hallym University Medical Center 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
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
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) 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Endocrine, nutritional and metabolic disease
pediatric obesity  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 10 Year ~ 14 Year
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No