Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749888
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2020-11-05
Brief Title:
Impact of the Korea Early Childhood Home-visiting Intervention
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Impact of the Korea Early Childhood Home-visiting Intervention on Childhood Health and Development and Maternal Health A Randomized Controlled Community Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KECHI
Brief Summary:
Maternal and early childhood home visits have been proposed as an effective strategy to improve the health and development of disadvantaged children In South Korea hereafter Korea a maternal and early childhood home visit program has been implemented since 2013 in Seoul and then was adopted in 2019 by the central government as a national policy for child health and development
The Korea Early Childhood Home-visiting Intervention KECHI encompasses 25-29 home visits group activities and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years as such it is a complex intervention involving various domains to address a wide range of outcomes Each home visit is implemented based on the familys needs and individualized interventions are provided to improve parenting and the home environment in order to promote childrens health and development and maternal health
This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on childrens health and development and maternal health
This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent Participants will then be randomly assigned to the intervention or control group with a 11 allocation through an independent web-based random allocation system We expect a total of 800 families 400 families in each group to be recruited The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services usual care but not multiple home visits by nurses Both groups will receive gift cards of 30000 Korean won about 27 USD for each round of surveys
The intervention and control groups will be surveyed on the outcome variables of home environment child development breastfeeding maternal health child hospital visits due to injuries and community service linkage at four home visits by trained research nurses at baseline and at 6 months 12 months and 24 months after birth Telephone contact will also be made at 6 weeks and 18 months after birth for both groups Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts The analysis will be conducted for the intention-to-treat ITT and per-protocol PP groups with an interim analysis of outcomes up to the 6-month follow-up For the primary outcomes and certain secondary outcomes subgroup analyses will be performed based on factors such as region fertility status number of risk factors presence of depression education level etc
The Korea Early Childhood Home-visiting Intervention KECHI encompasses 25-29 home visits group activities and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years as such it is a complex intervention involving various domains to address a wide range of outcomes Each home visit is implemented based on the familys needs and individualized interventions are provided to improve parenting and the home environment in order to promote childrens health and development and maternal health
This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on childrens health and development and maternal health
This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent Participants will then be randomly assigned to the intervention or control group with a 11 allocation through an independent web-based random allocation system We expect a total of 800 families 400 families in each group to be recruited The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services usual care but not multiple home visits by nurses Both groups will receive gift cards of 30000 Korean won about 27 USD for each round of surveys
The intervention and control groups will be surveyed on the outcome variables of home environment child development breastfeeding maternal health child hospital visits due to injuries and community service linkage at four home visits by trained research nurses at baseline and at 6 months 12 months and 24 months after birth Telephone contact will also be made at 6 weeks and 18 months after birth for both groups Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts The analysis will be conducted for the intention-to-treat ITT and per-protocol PP groups with an interim analysis of outcomes up to the 6-month follow-up For the primary outcomes and certain secondary outcomes subgroup analyses will be performed based on factors such as region fertility status number of risk factors presence of depression education level etc
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KCT0005579 | REGISTRY | None | None |
| HI19C0481 HC19C0048 | OTHER_GRANT | Ministry of Health and Welfare Republic of Korea | None |