UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054802 |
|---|---|
| Receipt number | R000062627 |
| Scientific Title | Nutritional management in support facilities for people with disabilities |
| Date of disclosure of the study information | 2024/07/19 |
| Last modified on | 2024/06/27 20:07:31 |
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Basic information
Public title
Nutritional management in support facilities for people with disabilities
Acronym
Nutritional management in support facilities for people with disabilities
Scientific Title
Nutritional management in support facilities for people with disabilities
Scientific Title:Acronym
Nutritional management in support facilities for people with disabilities
Region
| Japan |
Condition
Condition
Intellectual disability
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding the actual nutritional and eating challenges, as well as the dining environment, of people staying in support facilities for people with disabilities will lead to solving these issues and improving the dining environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It is expected that facilities that have registered dietitians on staff and that charge a nutritional care and management surcharge provide more appropriate dietary support and care.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants were recruited from a support facility for people with intellectual disabilities in Nagano Prefecture and agreed to participate in the research.
Key exclusion criteria
Facilities with 10 or fewer residents
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | sara |
| Middle name | |
| Last name | shimizu |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Health Science Major
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4413
whm23001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | sara |
| Middle name | |
| Last name | shimizu |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Health Science Major
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4413
Homepage URL
whm23001@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare Graduate School
Institute
Department
Personal name
Funding Source
Organization
Self-Procurement
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
Niigata University of Health and Welfare Graduate School
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4413
whm23001@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
| 2024 | Year | 07 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no
Management information
Registered date
| 2024 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062627
