UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051455 |
|---|---|
| Receipt number | R000058658 |
| Scientific Title | A survey to prevent malnutrition among the elderly living in Niigata Prefecture |
| Date of disclosure of the study information | 2023/06/27 |
| Last modified on | 2023/06/27 09:26:31 |
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Basic information
Public title
A survey to prevent malnutrition among the elderly living in Niigata Prefecture
Acronym
Research to prevent malnutrition in the elderly
Scientific Title
A survey to prevent malnutrition among the elderly living in Niigata Prefecture
Scientific Title:Acronym
A survey to prevent malnutrition among the elderly living in Niigata Prefecture
Region
| Japan |
Condition
Condition
malnutrition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Until now, the evaluation of the nutritional status of the elderly was limited to two items, weight loss and BMI (Body Mass Index), and it was not recognized as a support target unless it was clearly malnutrition. The purpose of this study is to examine appropriate nutritional screening methods to identify those at risk of malnutrition.
Basic objectives2
Others
Basic objectives -Others
Examination of screening methods for malnutrition in the elderly
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
height, weight, leg circumference, tongue pressure, grip strength, food intake frequency survey
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
| Behavior,custom |
Interventions/Control_1
The following items will be measured and investigated for the elderly. Age, sex, height, weight, body composition, food intake frequency survey, tongue pressure, grip strength
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who live independently at home
Key exclusion criteria
We excluded those who did not agree when we explained the purpose and method of the survey.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Inaba |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences,
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata, Japan
TEL
0252574413
inaba@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Nagai |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata, Japan
TEL
0252574481
Homepage URL
toru-nagai@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata, Japan
Tel
0252574418
toru-nagai@nuhw.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
| 2023 | Year | 06 | Month | 27 | 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
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058658
