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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037634
Receipt No. R000042912
Scientific Title Prospective observational study on the impact of socially implemented coparenting promotion programs on childcare
Date of disclosure of the study information 2019/10/01
Last modified on 2020/08/08

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Basic information
Public title Prospective observational study on the impact of socially implemented coparenting promotion programs on childcare
Acronym Coparenting cohort study
Scientific Title Prospective observational study on the impact of socially implemented coparenting promotion programs on childcare
Scientific Title:Acronym Coparenting cohort study
Region
Japan

Condition
Condition pregnancy
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the effect of coparenting promotion program to coparenting relationship and child-raring to 1000 days after childbirth.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Child growth and development
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 1) Pregnant couple with first child (including first-marriage couples, men and women, internal relationships)
(2) Both couples are Japanese
(3) Couples can take one or more of the two programs to promote marital cooperative childcare.
(4) Can read and write Japanese
(5) Those who have an Internet environment such as a smartphone or personal computer (because it is necessary for target registration and answering questionnaires)
(6) No mental illness during recruitment
(7) The fetus has no poor prognosis at the time of recruitment
Key exclusion criteria (1) A couple who already has children
(2) I can't read or write Japanese
(3) During recruitment, both couples have mental illness
(4) Fetal disease with poor prognosis at the time of recruitment
(5) In addition, when a researcher determines that participation in the research is inappropriate
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Toyoko
Middle name
Last name YOSHIZAWA
Organization Tohoku University,Graduate School of Medicine
Division name Women's health nursing & midwifery
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku,sendai
TEL +81227177957
Email ynaka@tohoku.ac.jp

Public contact
Name of contact person
1st name Yasuka
Middle name
Last name NAKAMURA
Organization Tohoku University,Graduate School of Medicine
Division name Women's health nursing & midwifery
Zip code 980-8575
Address 2-1 Seiryo-machi, Aoba-ku,sendai
TEL +81227177957
Homepage URL
Email ynaka@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tohoku University Graduate school of Med
Address 2-1,Seiryomachi, aobaku, sendai
Tel 022-717-7957
Email ynaka@tohoku.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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 01 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
2019 Year 08 Month 08 Day
Date of IRB
2019 Year 10 Month 29 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Scheduled follow-up for early pregnancy, late pregnancy, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years

Management information
Registered date
2019 Year 08 Month 08 Day
Last modified on
2020 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042912

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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