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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023780
Receipt No. R000027392
Scientific Title An evaluation of effectiveness of nutrition education intervention in undernourished individuals in healthcare facility for the elderly
Date of disclosure of the study information 2016/09/06
Last modified on 2017/02/27

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Basic information
Public title An evaluation of effectiveness of nutrition education intervention in undernourished individuals in healthcare facility for the elderly
Acronym Effects of nutrition education intervention in undernourished elderly
Scientific Title An evaluation of effectiveness of nutrition education intervention in undernourished individuals in healthcare facility for the elderly
Scientific Title:Acronym Effects of nutrition education intervention in undernourished elderly
Region
Japan

Condition
Condition malnutrition
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An evaluation of effectiveness of nutrition education intervention in undernourished individuals in healthcare facility for the elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Nutritional screening index (Mini-Nutritional Assessment Short Form: MNA)
Key secondary outcomes Anthropometric data (weight, body composition, arm circumference, triceps skinfold), Dietary intake (dietary intake, appetite) and Quality of life

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Participants receive the monthly individual nutrition counceling by a dietitian for 3 months.
Dietitians observe participants and adjust participants' diet in the healthcare facility for elderly based on their nutritional status.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Indivisuals with Mini-Nutritional Assessment Short Form (MNA-SF) score <7 in healthcare facilities for the elderly
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rie Akamatsu
Organization Ochanomizu University
Division name Natural Science Division, Faculty of Core Research
Zip code
Address 2-1-1 Otsuka Bunkyo-ku Tokyo 112-8610, Japan
TEL 03-5978-5680
Email Akamatsu.rie@ocha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yui Kawasaki
Organization Ochanomizu University
Division name Graduate School of Humanities and Sciences
Zip code
Address 2-1-1 Otsuka Bunkyo-ku Tokyo 112-8610, Japan
TEL 03-5978-5680
Homepage URL
Email g1570502@edu.cc.ocha.ac.jp

Sponsor
Institute Ochanomizu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 介護老人保健施設グリーン・ボイス(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 06 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 Completed
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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