UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on continuing support aimed at improvement of lifestyle habits of working women-Randomized Controlled Trial
Title of the study (Brief title)	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	Yukari Takemi
Organization	Kagawa Nutrition University
Division name	Nutrition Ecology
Address	3-9-21Chiyoda,Sakado, Saitama
TEL	049-282-3721
Email	takemi@eiyo.ac.jp

Public contact
Name of contact person	Kaoru Uno
Organization	Graduate school of Kagawa Nutrition University
Division name	Nutrition Ecology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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