UMIN-CTR Clinical Trial

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
Email	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
Email	mandai.marie.3n@kyoto-u.ac.jp

Sponsor
Institute	Ministry of Education,Culture,Sports,Science and Technology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047192