UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048524 |
|---|---|
| Receipt number | 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 | 2023/08/01 15:18:53 |
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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
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
baba-kr@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science Research Center
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055115
