UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028196 |
|---|---|
| Receipt number | 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 15:37:07 |
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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
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
ukb161@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032275
