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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042943
Receipt No. 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 2021/01/08

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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
Obsterics 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
Email 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
Email aya.ogawa.q1@dc.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate school of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 08 Day
Date of IRB
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
2021 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049022

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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