UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034201 |
|---|---|
| Receipt number | R000038987 |
| Scientific Title | Development and evaluation of the intervention program on improving work-life balance for working parents with pre-school child(ren): randomized control trial (multi-institutional joint research) |
| Date of disclosure of the study information | 2018/09/19 |
| Last modified on | 2019/09/25 10:27:42 |
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Basic information
Public title
Development and evaluation of the intervention program on improving work-life balance for working parents with
pre-school child(ren): randomized control trial (multi-institutional joint research)
Acronym
TWIN study 3
Scientific Title
Development and evaluation of the intervention program on improving work-life balance for working parents with
pre-school child(ren): randomized control trial (multi-institutional joint research)
Scientific Title:Acronym
TWIN study 3
Region
| Japan |
Condition
Condition
Working parents with pre-school child(ren)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide the program to improve work-life balance for working parents with pre-school child(ren) and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Work-life balance
2)Self-efficacy of Work-life balance
3)Psychological distress
4)Work engagement
Key secondary outcomes
1)Partner's work-life balance
2)Partner's self-efficacy of Work-life balance
3)Partner's psychological distress
4)Partner's work engagement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants who was assigned to intervention group will take the program that aim at improving work-life balance. The program provides them with knowledge and skills on stress management, communication, career plans, and child care. Participants take two three-hours programs.
Interventions/Control_2
Participants who was assigned to wait control group will spend usual days during intervention period. They take the same program as those in the intervention group after intervention period.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Working men and women
2) Having a pre-school child(ren)
Key exclusion criteria
1) Person who takes childcare leave
1) Person who does not live with a partner
Target sample size
1120
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Shimazu |
Organization
Keio University
Division name
Faculty of Policy Management
Zip code
252-0882
Address
5322 Endou, Fujisawa-city, Kanagawa, Japan
TEL
0466493638
ashimazu-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Shimazu |
Organization
Keio University
Division name
Faculty of Policy Management
Zip code
252-0882
Address
5322 Endou, Fujisawa-city, Kanagawa, Japan
TEL
0466493638
Homepage URL
https://hp3.jp/twin/
ashimazu-tky@umin.ac.jp
Sponsor or person
Institute
Faculty of Policy Management, Keio University
Institute
Department
Personal name
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
The Ethics Committee of Medical Science, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81-03-5841-3557
ethics@m.u-tokyo.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
慶應義塾大学（神奈川県）、福井大学（福井県）、信州大学（長野県）、名古屋大学（愛知県）、聖隷福祉事業団（静岡県）、広島国際大学（広島県）、長崎大学（長崎県）/Kitasato University (Kanagawa), University of Fukui (Fukui), Shinsyu University (Nagano), Nagoya University (Aichi)，Seirei Social Welfare Community (Shizuoka), Hiroshima International University (Hiroshima), Nagasaki University (Nagasaki)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 19 | 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
| 2018 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 19 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038987
