UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035894 |
|---|---|
| Receipt number | R000040896 |
| Scientific Title | Development of health literacy education program for prevention of allergy in children from pregnancy-pilot study- |
| Date of disclosure of the study information | 2019/02/16 |
| Last modified on | 2020/08/18 09:29:38 |
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Basic information
Public title
Development of health literacy education program for prevention of allergy in children from pregnancy-pilot study-
Acronym
Allergy prevention program from pregnancy-pilot study-
Scientific Title
Development of health literacy education program for prevention of allergy in children from pregnancy-pilot study-
Scientific Title:Acronym
Allergy prevention program from pregnancy-pilot study-
Region
| Japan |
Condition
Condition
non applicable
Classification by specialty
| Clinical immunology | Obstetrics and Gynecology | Pediatrics |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop allergy prevention program for children during pregnancy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
acceptability for the program
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
allergy prevention program
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pregnant woman and/or her partner
Key exclusion criteria
Unwillingness to comply with the study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kiwako |
| Middle name | |
| Last name | YAMAMOT-HANADA |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
03-3416-0181
yamamoto-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Kiwako |
| Middle name | |
| Last name | YAMAMOT-HANADA |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
03-3416-0181
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
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
Tel
0334160181
rinri@ncchd.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 16 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040896
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
