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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025178
Receipt No. 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

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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
Email 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
Email m-tamura@grp.ahv.pref.aichi.jp

Sponsor
Institute Aichi Health Promotion Public Interest Foundation
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028964

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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