臨床研究等提出・公開システム

Date of registration	Feb. 25, 2025
Last modified on	Feb. 25, 2025
Trial ID	jRCT1030240703

Scientific Title	Cohort Study in Okaya City, Nagano Prefecture: Relationship between Maternal and Child Health Information and Mental Health Status in the Sixth Grade of Elementary School
Public Title	Cohort Study in Okaya City

Contact for Scientific Queries	Name	Sasayama Daimei
	Affiliation	Shinshu University
	Address	3-1-1 Asahi, Matsumoto
	Telephone	+81-263-37-2638
	E-mail	sasayama@shinshu-u.ac.jp
Contact for Public Queries	Name	Sasayama Daimei
	Affiliation	Shinshu University
	Address	3-1-1 Asahi, Matsumoto
	Telephone	+81-263-37-2638
	E-mail	sasayama@shinshu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 28, 2021
Actual date of first enrollment		Nov. 19, 2021
Target sample size		1800
Study Type		Other
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1) The respondents born between April 2, 2009 and April 1, 2014, and their parents/guardians (2) Sixth-graders enrolled in elementary school in Okaya City at the time of the survey and their parents/guardians. (3) Those who agree (6th graders) and consent (parents) to the use of the data obtained from the questionnaire responses and maternal and child health information.
	Exclusion Criteria	Individuals deemed unsuitable as subjects by the principal investigator
	Age Minimum	11age old over
	Age Maximum	12age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		None
Primary Outcome(s)		Correlation between maternal and child health information and the results of a questionnaire for sixth-grade students
Secondary Outcome(s)		Relationship between questionnaire results and patient characteristics of sixth-grade students

Primary Sponsor	none

Source of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology
Secondary Sponsor	Not applicable

Name of Certified Review Board	Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address	3-1-1 Asahi, Matsumoto, Nagano
Telephone	+81-263-37-2572
E-Mail	md_rinri@shinshu-u.ac.jp
Approval Status	Approval
Date of approval	April. 28, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none