UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037634 |
|---|---|
| Receipt number | 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 | 2024/02/14 11:50:27 |
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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
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
ynaka@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
762
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
No longer 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
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042912
