UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062407 |
|---|---|
| Receipt number | R000071409 |
| Scientific Title | Effectiveness of a Multi-level Organizational Support and Comprehensive Initiatives for Menstrual Health and Workplace Well-being among Women Workers in Japan |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/31 11:12:18 |
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Basic information
Public title
Effectiveness of a Multi-level Organizational Support and Comprehensive Initiatives for Menstrual Health and Workplace Well-being among Women Workers in Japan
Acronym
MOSAIC-W Project(Multi-level Organizational Support and Comprehensive Initiatives for Menstrual Health and Workplace Well-beingamong Women Workers in Japan)
Scientific Title
Effectiveness of a Multi-level Organizational Support and Comprehensive Initiatives for Menstrual Health and Workplace Well-being among Women Workers in Japan
Scientific Title:Acronym
MOSAIC-W Project(Multi-level Organizational Support and Comprehensive Initiatives for Menstrual Health and Workplace Well-beingamong Women Workers in Japan)
Region
| Japan |
Condition
Condition
Menstrual-related symptoms and menopausal symptoms
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate a multicomponent workplace intervention combining organizational-level intervention, supervisor training, and individual training for female employees, and to examine its effects on menstrual-related symptoms and work productivity among female workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Severity of menstrual-related symptoms (assessed by PMS-8 and dysmenorrhea score, change from baseline to final survey)
Key secondary outcomes
(1) Work productivity, assessed by presenteeism items from the WHO Health and Work Performance Questionnaire (WHO-HPQ)
(2) Psychological distress, assessed by the 6-item Kessler Psychological Distress Scale (K6)
(3) Job demands and job control, assessed by items derived from the Brief Job Stress Questionnaire (BJSQ)
(4) Work engagement, assessed by the 3-item Utrecht Work Engagement Scale (UWES-3)
(5) Subjective well-being, assessed by the WHO-5 Well-Being Index
(6) Work-family conflict, assessed by the Japanese version of the Survey Work-home Interaction Nijmegen (SWING-J)
Change from baseline to final survey will be assessed for all items.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Organizational-level workplace initiatives. Company representatives select and implement measures from a list of workplace initiatives tailored to their organization's circumstances. Research collaborators provide periodic progress checks and advice.
Individual training for female employees. A training session aimed at improving health literacy regarding female-specific health issues and promoting mental health care.
Training for supervisors and managers. Covers management skills for supporting subordinates' work-life balance, knowledge of female-specific health issues, communication methods, workload optimization, and line care for mental health.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Female workers: (1) employed at a company participating in this study; (2) aged 18 years or older; (3) received an explanation of the study and provided consent to participate.
Supervisors/managers (male and female): (1) employed at a company participating in this study; (2) aged 18 years or older; (3) received an explanation of the study and provided consent to participate.
Key exclusion criteria
NONE
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Natsu |
| Middle name | |
| Last name | Sasaki |
Organization
The University of Tokyo
Division name
Department of Mental Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413584
1650751435@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | OKIKAZE |
| Middle name | |
| Last name | KATO |
Organization
University of Tokyo
Division name
Department of Reproductive and Developmental Medicine, Graduate School of Medicine, The University o
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358008892
Homepage URL
https://mhpn.m.u-tokyo.ac.jp/rs/oo
1650751435@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Kitazato
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine / Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
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
Other administrative information
Date of disclosure of the study information
| 2026 | 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
No
IPD sharing Plan description
None
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071409
