UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023780 |
|---|---|
| Receipt number | 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 14:59:48 |
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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
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
g1570502@edu.cc.ocha.ac.jp
Sponsor or person
Institute
Ochanomizu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027392
