UMIN-CTR Clinical Trial

Basic information
Public title	Study on body composition and function of working generation
Acronym	Study on body composition and function of working generation
Scientific Title	Study on body composition and function of working generation
Scientific Title:Acronym	Study on body composition and function of working generation
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the characteristics of worker's behavioral strength and lifestyle habits
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition grip strength 2-step test
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Body composition grip strength 2-step test
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2)Working people 3)Adults over 20 years old
Key exclusion criteria	1)persons under 20 2) persons who did not get consent 3) persons who are judged to be inappropriate for inclusion in the study by the principal investigator / partner and the medical staff involved in the study
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kitagawa Middle name Last name Hitomi
Organization	Kinki Health Administration Center (KKC)
Division name	Medical practice management unit
Zip code	520-0812
Address	10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
TEL	050-3530-4268
Email	h_kitagawa@zai-kkc.or.jp

Public contact
Name of contact person	1st name Takariki Middle name Last name Yoko
Organization	Kinki Health Administration Center (KKC)
Division name	Corporate Planning Group
Zip code	520-0812
Address	10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
TEL	077-525-5412
Homepage URL
Email	y_takariki@zai-kkc.or.jp

Sponsor
Institute	Kinki Health Administration Center
Institute
Department

Funding Source
Organization	Kinki Health Administration Center
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	Central Research Ethic Committee, Kinki Health Administration Center
Address	10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
Tel	077-525-5418
Email	t_hachio@zai-kkc.or.jp

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	2020 Year 07 Month 15 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	463
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	2020 Year 07 Month 14 Day
Date of IRB	2020 Year 07 Month 14 Day
Anticipated trial start date	2020 Year 07 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 05 Month 31 Day
Date trial data considered complete	2021 Year 07 Month 31 Day
Date analysis concluded	2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 07 Month 15 Day
Last modified on	2021 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046954