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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034201
Receipt No. 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 2019/04/14

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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
Email 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 Endiu, Fujisawa-city, Kanagawa, Japan
TEL 0466493638
Homepage URL https://hp3.jp/twin/
Email ashimazu-tky@umin.ac.jp

Sponsor
Institute Faculty of Policy Management, Keio University
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 06 Day
Last follow-up date
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 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038987

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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