UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043748 |
|---|---|
| Receipt number | R000047192 |
| Scientific Title | A study of the effects of prenatal education for pregnant women using the LINE app |
| Date of disclosure of the study information | 2021/03/26 |
| Last modified on | 2022/03/29 13:59:38 |
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Basic information
Public title
e-ryousingakkyu
Acronym
e-ryousingakkyu
Scientific Title
A study of the effects of prenatal education for pregnant women using the LINE app
Scientific Title:Acronym
A study of the effects of prenatal education for pregnant women using the LINE app
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this study aimed to test the hypothesis that mothers who took prenatal education using the app will have higher self-efficacy and less loneliness for parenting after the first month postpartum than those who did not take the app.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-efficacy at one month postpartum
Key secondary outcomes
Loneliness at one month postpartum
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Twice a day, the site sends participants quizzes on parenting information via the LINE. More detailed information on childcare is also provided on the column site.
Interventions/Control_2
Control
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who are 20 years of age or older, first childbirth at 28 weeks of pregnancy or later, who understand Japanese and have access to the LINE app with a smartphone.
Key exclusion criteria
Twins and more
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nakayama |
Organization
Kyoto University School of Public Health
Division name
Health Informatics
Zip code
606-8501
Address
Konoe-cho,Yoshida,Sakyo-ku,City of Kyoto, Kyoto Prefecture
TEL
075-753-4488
makayama.takeo.4a@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto University School of Public Health
Division name
Health Informatics
Zip code
606-8501
Address
Konoe-cho,Yoshida,Sakyo-ku,City of Kyoto, Kyoto Prefecture
TEL
075-753-9477
Homepage URL
mandai.marie.3n@kyoto-u.ac.jp
Sponsor or person
Institute
Ministry of Education,Culture,Sports,Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education Culture Sports Science and Technology
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 26 | 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
455
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
| 2020 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047192
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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