UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028049 |
|---|---|
| Receipt number | 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 | 2020/07/31 13:49:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Yasuko |
| Middle name | Sarah |
| Last name | Nagamatsu |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
1040044
Address
10-1 Akashi-cho, Cho-ku, Tokyo
TEL
03-5550-2262
sarah-nagamatsu@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagamatsu |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
1040044
Address
10-1 Akashi-cho, Cho-ku, Tokyo
TEL
03-5550-2262
Homepage URL
sarah-nagamatsu@slcn.ac.jp
Sponsor or person
Institute
Ministry of education and welfare
Institute
Department
Personal name
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
St. Luke's International University
Address
10-1 Akashi-cho, Vhuo-ku, Tokyo
Tel
03-5550-2262
sarah-nagamatsu@slcn.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
| 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
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
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032117
