UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055270 |
|---|---|
| Receipt number | R000062844 |
| Scientific Title | Influence of the food environment on the eating behavior of older residents in long-term care facilities |
| Date of disclosure of the study information | 2024/08/17 |
| Last modified on | 2025/09/19 20:11:42 |
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Basic information
Public title
Influence of the food environment on the eating behavior of older residents in long-term care facilities
Acronym
Influence of the food environment on the eating behavior of older residents in long-term care facilities
Scientific Title
Influence of the food environment on the eating behavior of older residents in long-term care facilities
Scientific Title:Acronym
Influence of the food environment on the eating behavior of older residents in long-term care facilities
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether table coordination during food service in long-term care facilities is useful for residents' eating behavior
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in dietary intake before and after intervention
Key secondary outcomes
Change in level of vitality, appetite, and meal satisfaction before and after the intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Table coordination A, (Wash out), Table coordination B
Interventions/Control_2
Table coordination B, (Wash out), Table coordination A
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older residents who can take oral intake and written consent has been obtained freely and voluntarily.
Key exclusion criteria
Exclude those who regularly take medications with the side effect of decreased appetite.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Komenami |
Organization
Kyoto Women's University
Division name
Faculty of Home Economics
Zip code
605-8501
Address
35 Imakumano-kitahiyoshi-cho, Higashiyama-ku, Kyoto City, Japan
TEL
075-531-7115
komenami@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Komenami |
Organization
Kyoto Women's University
Division name
Faculty of Home Economics
Zip code
605-8501
Address
35 Imakumano-kitahiyoshi-cho, Higashiyama-ku, Kyoto City, Japan
TEL
075-531-7115
Homepage URL
komenami@kyoto-wu.ac.jp
Sponsor or person
Institute
Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Women's University
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
Clinical Research Ethics Review Committee of Kyoto Women's University
Address
35 Imakumano-kitahiyoshi-cho, Higashiyama-ku, Kyoto City, Japan
Tel
075-751-6232
kenkyukikaku@kyoto-wu.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 | 08 | Month | 17 | 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
18
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
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062844
