UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study on Specific Health Checkups and Specific Health Guidance for frailty in community-dwelling adults
Acronym	Intervention study on Specific Health Checkups and Specific Health Guidance for frailty
Scientific Title	Intervention study on Specific Health Checkups and Specific Health Guidance for frailty in community-dwelling adults
Scientific Title:Acronym	Intervention study on Specific Health Checkups and Specific Health Guidance for frailty
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate whether the approach of interventions including health guidance for frailty and providing health information improve prevalence of frailty and sarcopenia, deficiency of protein intake, oral frailty, and social cognitive function in community-dwelling adults.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of frailty (kihon checklist)
Key secondary outcomes	1) Appendicular skeletal muscle mass 2) Score of kihon checklist 3) Lifestyle

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	Health guidance for frailty (frail adult) Providing health information (no frail adult)
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Person who hope to participate in this study 2) Informed consent
Key exclusion criteria	1) Person who cannot an independent daily life 2) Person who have certification of Needed Long-Term Care and Certification of Needed Support in baseline 3) Person who have serious disease (stroke, heart disease and cancer etc)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name keiichi Middle name Last name Abe
Organization	National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Division name	Section of Healthy Longevity Research
Zip code	162-8636
Address	1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3203-5721
Email	k-abe@nibiohn.go.jp

Public contact
Name of contact person	1st name Motohiko Middle name Last name Miyachi
Organization	National Institute of Health and Nutrition, NIBIOHN
Division name	Department of Health Promotion and Exercise
Zip code	162-8636
Address	1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3203-8061
Homepage URL
Email	miyachi@nibiohn.go.jp

Sponsor
Institute	National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

Funding Source
Organization	Osaka prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Osaka Prefectural Government Department of Health and Medical Care
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Institutes of Biomedical Innovation, Health and Nutrition
Address	7-6-8 Saito-Azaki, Ibaraki-shi, Oosaka 567-0085
Tel	072-641-9811
Email	proj14@nibiohn.go.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	2019 Year 05 Month 29 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	100
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	2019 Year 05 Month 21 Day
Date of IRB	2019 Year 06 Month 20 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 11 Month 14 Day
Date analysis concluded	2019 Year 11 Month 26 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 29 Day
Last modified on	2019 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042027