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Development and Evaluation of Community-based Healthy Eating Management Program for Children from Low-incomes Families in South Korea: Using Intervention Mapping

Status Approved

First Submitted Date

2019/04/15
Registered Date

2019/09/16
Last Updated Date

2019/09/11

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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	KCT0004296
Unique Protocol ID	INJE 2019-01-011-001
Public/Brief Title	Development and Evaluation of Community-based Healthy Eating Management Program for Children from Low-incomes Families in South Korea: Using Intervention Mapping
Scientific Title	Development and Evaluation of Community-based Healthy Eating Management Program for Children from Low-incomes Families in South Korea: Using Intervention Mapping
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
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	INJE 2019-01-011-001
Approval Date	2019-03-05
Institutional Review Board Name	Institutional Review Board of Inje University
Institutional Review Board Address	75, Bokji-ro, Busanjin-gu, Busan
Institutional Review Board Telephone	055-320-3068
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	Jiyoung Park
Title	Assistant Professor
Telephone	+82-51-890-6079
Affiliation	Inje University
Address	75, Bokji-ro, Busanjin-gu, Busan
Contact Person for Public Queries
Name	Jiyoung Park
Title	Assistant Professor
Telephone	+82-51-890-6079
Affiliation	Inje University
Address	75, Bokji-ro, Busanjin-gu, Busan
Contact Person for Updating Information
Name	Jiyoung Park
Title	Assistant Professor
Telephone	+82-51-890-6079
Affiliation	Inje University
Address	75, Bokji-ro, Busanjin-gu, Busan

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-03-05 Actual
Target Number of Participant	700
Primary Completion Date	2019-09-30 , Anticipated
Study Completion Date	2019-09-30 , Anticipated
Name of Study	Inje University
Recruitment Status	Recruiting
Date of First Enrollment	2019-03-05 ,

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	Others
Project ID	2018R1A1A1A0507914

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Effective strategies to reduce disparities in childhood obesity need to be developed and prioritized. The purpose of the study is to develop and evaluate the effectiveness of obesity prevention program to improve eating behavior for low-income children based on the Community Child Care (CCC) centers, using Intervention Mapping. CCC centers in South Korea are part of the health policy for vulnerable children and children with disabilities funded by the Korean Ministry of Health and Welfare. They provide after-school activities and care, especially for children from low-income families. The embedded experimental model of concurrent mixed methods will be used to better understand research outcomes by converging both quantitative and qualitative data.

Study Summary Information

Lay Summary

Effective strategies to reduce disparities in childhood obesity need to be developed and prioritized. The purpose of the study is to develop and evaluate the effectiveness of obesity prevention program to improve eating behavior for low-income children based on the Community Child Care (CCC) centers, using Intervention Mapping. CCC centers in South Korea are part of the health policy for vulnerable children and children with disabilities funded by the Korean Ministry of Health and Welfare. They provide after-school activities and care, especially for children from low-income families. The embedded experimental model of concurrent mixed methods will be used to better understand research outcomes by converging both quantitative and qualitative data.

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	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Non-RCT
Intervention Type	Behavioral
Intervention Description	① Opening ceremony: The program takes place in the first week of the program: Introduction of pre-test results(children's obesity rate and eating behaviors of each center) and programs, also delivering the signboards. ② Cooking class: It is held every Wednesday for cooking assistants with six sessions. The main topics consist of following healthy recipe, using cooking devices and making seasonal foods. ③ Nutrition education : Five sessions of nutrition education are held for the service providers. It takes about 10-15 minutes per session, and the main topics include defining a healthy diet, finding the healthy menu and recipes, and so on. ④ Nutrition diary: The service providers plan the weekly menu and shopping and monitor centers' eating behaviors and taste of food, using nutrition diary. ⑤ Completion ceremony: At the end of the program, the service providers disscuss on the barriers and alternations to continue healthy eating behaviors at the center.
Number of Arms	2
Arm 1	Arm Label Community Child Care Center in S District (service providers and children at center)
	Target Number of Participant 350
	Arm Type Experimental
	Arm Description ① Opening ceremony: The program takes place in the first week of the program: Introduction of pre-test results(children's obesity rate and eating behaviors of each center) and programs, also delivering the signboards. ② Cooking class: It is held every Wednesday for cooking assistants with six sessions. The main topics consist of following healthy recipe, using cooking devices and making seasonal foods. ③ Nutrition education : Five sessions of nutrition education are held for the service providers. It takes about 10-15 minutes per session, and the main topics include defining a healthy diet, finding the healthy menu and recipes, and so on. ④ Nutrition diary: The service providers plan the weekly menu and shopping and monitor centers' eating behaviors and taste of food, using nutrition diary. ⑤ Completion ceremony: At the end of the program, the service providers disscuss on the barriers and alternations to continue healthy eating behaviors at the center.
Arm 2	Arm Label Community Child Care Center in B District (service providers and children at center)
	Target Number of Participant 350
	Arm Type No intervention
	Arm Description ① Launch ceremony: The program takes place in the first week of the program: Introduction of pre-test results(children's obesity rate and eating behaviors of each center) and programs, also delivering the signboards. ② Cooking class: It is held every Wednesday for cooking assistants with six sessions. The main topics consist of following healthy recipe, using cooking devices and making seasonal foods. ③ Nutrition education : Five sessions of nutrition education are held for the service providers. It takes about 10-15 minutes per session, and the main topics include defining a healthy diet, finding the healthy menu and recipes, and so on. ④ Nutrition diary: The service providers plan the weekly menu and shopping and monitor centers' eating behaviors and taste of food, using nutrition diary. ⑤ Completion ceremony: At the end of the program, the service providers disscuss on the barriers and alternations to continue healthy eating behaviors at the center.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified None
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 6Year~60Year
	Description 1) Children aged 6 to 13 from low-income families using Community Child Care Centers 2) Service providers working at Community Child Care Centers
Exclusion Criteria	Children with health problems or participating in the other obesity prevetion programs
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	BMI
Timepoint	before/after intervention
Primary Outcome(s) 2
Outcome	eating habits
Timepoint	before/after intervention
Primary Outcome(s) 3
Outcome	perception/risk recognition of dietary management
Timepoint	before/after intervention
Primary Outcome(s) 4
Outcome	skills/self-efficacy in the management of eating habits
Timepoint	before/after intervention
Primary Outcome(s) 5
Outcome	Attitudes/expectation outcomes on dietary management
Timepoint	before/after intervention
Primary Outcome(s) 6
Outcome	norms/social support for eating habits
Timepoint	before/after intervention
Secondary Outcome(s) 1
Outcome	Food intake
Timepoint	before/after intervention

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	Yes
Time of Sharing	2020. 3
Way of Sharing	To be made available at a later date (mihae1219@naver.com)

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