UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study of nutrition care and management at day-care facilities for the aged.
Acronym	Intervention study of nutrition care and management at day-care facilities for the aged.
Scientific Title	Intervention study of nutrition care and management at day-care facilities for the aged.
Scientific Title:Acronym	Intervention study of nutrition care and management at day-care facilities for the aged.
Region	Japan

Condition
Condition	malnutrition
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to test the introduction and development of the "Comprehensive Nutrition Care and Management" system and activities, including activities for home visits and oral maintenance in the elderly's day-care facilities.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	activities of daily living "6 months"
Key secondary outcomes	nutritional states

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	Treatment
Type of intervention	Other
Interventions/Control_1	Nutrition care "6 months"
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	65 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	malnutrition
Key exclusion criteria	No concent
Target sample size	225

Research contact person
Name of lead principal investigator	1st name Michiko Middle name Last name Sugiyama
Organization	Kanagawa University of Human Services
Division name	School of Nutrition and Dietetics
Zip code	2388522
Address	1-10-1 Heiseicho, Yokosuka-city, Kanagawa, Japan
TEL	0468282500
Email	takada-dn2@kuhs.ac.jp

Public contact
Name of contact person	1st name Kento Middle name Last name Takada
Organization	Kanagawa University of Human Services
Division name	School of Nutrition and Dietetics
Zip code	238-8522
Address	1-10-1 Heiseicho, Yokosuka-city, Kanagawa, Japan
TEL	046-828-2813
Homepage URL
Email	takada-dn2@kuhs.ac.jp

Sponsor
Institute	Japanese Society on Nutrition Care and Management
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanagawa University of Human Services
Address	1-10-1 Heiseicho, Yokosuka-city, Kanagawa, Japan
Tel	046-828-2500
Email	takada-dn2@kuhs.ac.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 12 Month 12 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	Enrolling by invitation
Date of protocol fixation	2019 Year 08 Month 21 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 12 Day
Last modified on	2019 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044318