UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Educational program about food allergy for children based on science communication
Title of the study (Brief title)	Educational program about food allergy for children based on science communication
Region	Japan

Condition
Condition	all children with/without food allergy
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of educational program about food allergy based on science communication for children
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change in knowledge and understanding about food allergy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Educational program about food allergy based on science communication
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	1st grade to 6th grade children
Key exclusion criteria	1.children who are not willing to participate in our study. 2.caregivers of the children who disagree their children attending our study.
Target sample size	120

Research contact person
Name of lead principal investigator	Kiwako Yamamoto-Hanada
Organization	National Center for Child Health and Development
Division name	Division of Allergy
Address	2-10-1 Okura, Setagaya, Tokyo, Japan
TEL	+81-3-3416-0181
Email	yamamoto-k@ncchd.go.jp

Public contact
Name of contact person	Kiwako Yamamoto-Hanada
Organization	National Center for Child Health and Development
Division name	Division of Allergy
Address	2-10-1 Okura, Setagaya, Tokyo, Japan
TEL	+81-3-3416-0181
Homepage URL
Email	yamamoto-k@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	the Japan Society for the Promotion of Science (JSPS) KAKENHI Grant Number 26870890
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立成育医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 26 Day
Anticipated trial start date	2015 Year 06 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27372656
Results
Other related information

Management information
Registered date	2015 Year 06 Month 02 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020459