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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028049
Receipt No. R000032117
Scientific Title Evaluation of the health promotion program for middle-aged migrant women in Japan
Date of disclosure of the study information 2017/07/03
Last modified on 2017/07/03

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Basic information
Public title Evaluation of the health promotion program for
middle-aged migrant women in Japan
Acronym health promotion program for
middle-aged migrant women
Scientific Title Evaluation of the health promotion program for
middle-aged migrant women in Japan
Scientific Title:Acronym health promotion program for
middle-aged migrant women
Region
Japan

Condition
Condition Non-communicable diseases
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the health promotion program for middle-aged migrant women in Japan
Basic objectives2 Others
Basic objectives -Others To reveal the concern about aging of middle-aged migrant women in Japan
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confidence score to keep health for 10 yeas at pretest, post-test and one month after the program
Key secondary outcomes Overall well being score and PHQ-9

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise every 2 weeks for 3 months
Check weight, abdomen girth and blood pressure for 8 times
3 education about female diseases
Cervical cancer check up in English for applicant
Interventions/Control_2 No exercise
Check weight, abdomen girth and blood pressure for 3 times
3 education about female diseases.
Cervical cancer check up in English for applicant
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
40 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Who lives in Tokyo and surrounding area. Permanent resident, wife of permanent resident of wife of Japanese
Key exclusion criteria Who was advised not to exercise
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuko Nagamatsu
Organization St. Luke's International University
Division name College of Nursing
Zip code
Address 10-1 Akashi-cho, Cho-ku, Tokyo
TEL 03-5550-2262
Email sarah-nagamatsu@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Nagamatsu
Organization St. Luke's International University
Division name College of Nursing
Zip code
Address 10-1 Akashi-cho, Cho-ku, Tokyo
TEL 03-5550-2262
Homepage URL
Email sarah-nagamatsu@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization MEXT(Japan)KAKENHI
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
Address
Tel
Email

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
2017 Year 07 Month 03 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
2017 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 03 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032117

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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