UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042943 |
|---|---|
| Receipt number | R000049022 |
| Scientific Title | Development of mobile health intervention to support pregnant women's job adjustment |
| Date of disclosure of the study information | 2021/01/08 |
| Last modified on | 2023/06/02 15:37:26 |
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Basic information
Public title
Development of mobile health intervention to support pregnant women's job adjustment
Acronym
Development of mobile health intervention to support pregnant women's job adjustment
Scientific Title
Development of mobile health intervention to support pregnant women's job adjustment
Scientific Title:Acronym
Development of mobile health intervention to support pregnant women's job adjustment
Region
| Japan |
Condition
Condition
Healthy pregnant women
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is development of mobile health intervention to support pregnant women's job adjustment, and to examine its feasibility and effectiveness. (Historical control is the previous data of the pregnant women)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occupational stress responses at second trimester
Key secondary outcomes
1)Occupational stressors
2)Anxiety about job adjustment
3)Work Engagement
4)Work productivity (presenteeism)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of job adjustment smartphone application to observe job and physical status and receive action suggestions and information based on these observations. (Once every 1-2 weeks, First trimester to third trimester)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women
1)who are between 8 weeks and 16 weeks of gestation
2)who are employed
3)who own a smart phone.
4)with a singleton pregnancy
5)who can read and write Japanese
6)with no medical limitations in employment or physical activity at the time of study participation
Key exclusion criteria
Women
1)who are planning to take leave or resign before 30 week of gestation
2)who are undergoing treatment for mental disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuka |
| Middle name | |
| Last name | NAKAMURA |
Organization
Tohoku University Graduate school of Medicine
Division name
Women's Health Nursing & Midwifery
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL
022-717-7957
ynaka@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | WADA |
Organization
Tohoku University Graduate school of Medicine
Division name
Women's Health Nursing & Midwifery
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL
022-717-7957
Homepage URL
aya.ogawa.q1@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Science Center Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
Tel
022-728-4105
med-kenkyo@grp.tohoku.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
| 2021 | Year | 01 | Month | 08 | 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
| 2021 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049022
