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
CRIS Registration Number |
KCT0004137 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 3 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Centers for Disease Control and Prevention |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hallym University Medical Center |
Organization Type | Medical Institute |
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified pediatric obesity |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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