UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the lifestyle intervention on women's health
Title of the study (Brief title)	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	Akiko Muramoto
Organization	Aichi Health Promotion Public Interest Foundation
Division name	Comprehensive Health Science Center
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	Midori Tamura
Organization	Aichi Health Promotion Public Interest Foundation
Division name	Comprehensive Health Science Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 28 Day
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

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Publication of results	Unpublished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