UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025178 |
|---|---|
| Receipt number | R000028964 |
| Scientific Title | The study of the lifestyle intervention on women's health |
| Date of disclosure of the study information | 2016/12/10 |
| Last modified on | 2019/01/04 09:55:11 |
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Basic information
Public title
The study of the lifestyle intervention on women's health
Acronym
The study on women's health
Scientific Title
The study of the lifestyle intervention on women's health
Scientific Title:Acronym
The study on women's health
Region
| Japan |
Condition
Condition
emaciation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of maintenance and improvement of muscle mass and physical fitness by exercise and effect of health by appropriate dietary behavior
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BMI,muscle mass,bone density,Completion rate
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lifestyle intervention program verification to lead to action transformation
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
emaciation
Key exclusion criteria
Pregnant person
Person during mental disease treatment such as the depression
Under treatment of myocardial infarction and apoplexy.
Subjects prohibited from participating the program by medical doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Muramoto |
Organization
Aichi Health Promotion Public Interest Foundation
Division name
Comprehensive Health Science Center
Zip code
Address
Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL
0562-82-0211
a-muramoto@grp.ahv.pref.aichi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Tamura |
Organization
Aichi Health Promotion Public Interest Foundation
Division name
Comprehensive Health Science Center
Zip code
Address
Gengoyama1-1, Morioka, Higashiura-cho, Chita-gun, Aichi, Japan
TEL
0562-82-0211
Homepage URL
m-tamura@grp.ahv.pref.aichi.jp
Sponsor or person
Institute
Aichi Health Promotion Public Interest Foundation
Institute
Department
Personal name
Funding Source
Organization
Aichi Health Promotion Public Interest Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 10 | 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
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028964
