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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048524
Receipt No. R000055115
Scientific Title The Early Partnership Project: evaluation of a new community service
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/29

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Basic information
Public title The Early Partnership Project: evaluation of a new community service
Acronym Evaluation of the Early Partnership Project
Scientific Title The Early Partnership Project: evaluation of a new community service
Scientific Title:Acronym Evaluation of the Early Partnership Project
Region
Japan

Condition
Condition Pregnant Women
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the effectiveness of new services aimed at improving shortcomings of existing child care support services, based on survey data from a cohort of pregnant women.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maternal perceived capacity in life
Key secondary outcomes Maternal Service Usage
Maternal Service Satisfaction
Maternal Attachment
Information recorded in the Maternal & Child Healthcare Handbook (Birth weight, Gestational age at birth, maternal difficulty in childcare, etc.)
Social Support
Maternal mental well-being (WHO5)
Maternal depression (EPDS)
Maternal self esteem (Rosenberg self esteem scale)
Maternal auditory hallucination experiences
Maternal attitudes toward childcare

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Eligible women receive regular support from a trained Family Support Workers in the community from the time of conception through the first year postpartum.
Family Support Workers will support eligible women from early gregnancy up to 1 year after childbirth. The FSWs will hold multidisciplinary discussion meetings to evaluate lifestyle and psychological state etc., identify unmet needs, and establish action plans for the participating women.
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
16 years-old <=
Age-upper limit
25 years-old >=
Gender Female
Key inclusion criteria Pregnant women who will submit their pregnancy notification during the 8-month period from August 2022 to March 2023 (with the possibility of extension), who are first-time pregnant women between the ages of 16 and 25 and who are able to answer the questionnaire in Japanese.
Key exclusion criteria If an eligible pregnant woman is identified, but already has plans to move out of the municipality permanently, she will not be recruited to the program.
However, if the move is temporary (for example, in the case of returning to her hometown to give birth), she will be recruited.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Baba
Organization Tokyo Metropolitan Institute of Medical Science Research Center
Division name Research Center for Social Science & Medicine Unit for Mental Health Promotion
Zip code 1568506
Address 2-1-6 Kamikitazawa, Setagayaku, Tokyo
TEL +81-3-6834-2293
Email baba-kr@igakuken.or.jp

Public contact
Name of contact person
1st name Kaori
Middle name
Last name Baba
Organization Tokyo Metropolitan Institute of Medical Science
Division name Research Center for Social Science & Medicine Unit for Mental Health Promotion
Zip code 1568506
Address 2-1-6 Kamikitazawa, Setagayaku, Tokyo
TEL +81-3-6834-2293
Homepage URL
Email baba-kr@igakuken.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Medical Science Research Center
Institute
Department

Funding Source
Organization Commissioned by Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Center for Medical Research Cooperation, Tokyo Metropolitan Institute of Medical Science
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel +81-3-6834-2391
Email renkei@igakuken.or.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
2022 Year 08 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 Preinitiation
Date of protocol fixation
2022 Year 07 Month 01 Day
Date of IRB
2022 Year 07 Month 21 Day
Anticipated trial start date
2022 Year 08 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

Management information
Registered date
2022 Year 07 Month 30 Day
Last modified on
2022 Year 07 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055115

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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