UMIN-CTR Clinical Trial

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 Endou, 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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038987