UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017772 |
|---|---|
| Receipt number | R000020459 |
| Scientific Title | Educational program about food allergy for children based on science communication |
| Date of disclosure of the study information | 2015/06/04 |
| Last modified on | 2018/12/20 12:27:04 |
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Basic information
Public title
Educational program about food allergy for children based on science communication
Acronym
Educational program about food allergy for children based on science communication
Scientific Title
Educational program about food allergy for children based on science communication
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kiwako Yamamoto-Hanada |
Organization
National Center for Child Health and Development
Division name
Division of Allergy
Zip code
Address
2-10-1 Okura, Setagaya, Tokyo, Japan
TEL
+81-3-3416-0181
yamamoto-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiwako Yamamoto-Hanada |
Organization
National Center for Child Health and Development
Division name
Division of Allergy
Zip code
Address
2-10-1 Okura, Setagaya, Tokyo, Japan
TEL
+81-3-3416-0181
Homepage URL
yamamoto-k@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27372656
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020459
