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

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 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

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

Value
https://center6.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