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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028196
Receipt No. R000032275
Scientific Title Research on continuing support aimed at improvement of lifestyle habits of working women-Randomized Controlled Trial
Date of disclosure of the study information 2017/08/10
Last modified on 2017/07/12

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Basic information
Public title Research on continuing support aimed at improvement of lifestyle habits of working women-Randomized Controlled Trial
Acronym Research on continuing support aimed at improvement of lifestyle habits of working women
Scientific Title Research on continuing support aimed at improvement of lifestyle habits of working women-Randomized Controlled Trial
Scientific Title:Acronym Research on continuing support aimed at improvement of lifestyle habits of working women
Region
Japan

Condition
Condition Under weight,Menstrual pain,Headache
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify what is necessary for a work woman to continue proper lifestyle
Basic objectives2 Others
Basic objectives -Others continuity
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes BMI,Subjective health impression
Key secondary outcomes dietary intake

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 once group session 90 minutes
twice mail contact during one month
Interventions/Control_2 Providing a health notebook on diet, physical activity, sleep
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
40 years-old >
Gender Female
Key inclusion criteria Over 20 years old Under 40 years old women
Key exclusion criteria Maternal woman, lactating woman, under treatment, under medication
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari Takemi
Organization Kagawa Nutrition University
Division name Nutrition Ecology
Zip code
Address 3-9-21Chiyoda,Sakado, Saitama
TEL 049-282-3721
Email takemi@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Uno
Organization Graduate school of Kagawa Nutrition University
Division name Nutrition Ecology
Zip code
Address 3-9-21Chiyoda,Sakado, Saitama
TEL 049-282-3721
Homepage URL
Email ukb161@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

Funding Source
Organization Kagawa Nutrition University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Luvtelli
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 Will Conscious Marunouchi実行委員会

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 15 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 12 Day
Last modified on
2017 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032275

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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