UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054221 |
|---|---|
| Receipt number | R000061914 |
| Scientific Title | Development of a program to comprehensively support food accessibility for community-dwelling older people in urban cities |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2025/04/22 09:18:59 |
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Basic information
Public title
Development of a program to comprehensively support food accessibility for community-dwelling older people in urban cities
Acronym
Development of a program to comprehensively support food accessibility
Scientific Title
Development of a program to comprehensively support food accessibility for community-dwelling older people in urban cities
Scientific Title:Acronym
Development of a program to comprehensively support food accessibility
Region
| Japan |
Condition
Condition
malnutrition
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a program to comprehensively support food accessibility and to investigate whether this program improve dietary variety, nutritional status and food accessibility for older people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dietary variety score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
to participate a program to comprehensively support food accessibility
Interventions/Control_2
not to participate a program to comprehensively support food accessibility
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
a community-dwelling people aged 65 or older who participated prior health checkup program
Key exclusion criteria
An individual who are certificated as care-need level 3 or more, cannot walk independently, are diagnosed as dementia, and are in hospital admission or discharged within one month
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Iizaka |
Organization
Shukutoku university
Division name
College of Nursing and Nutrition
Zip code
260-8703
Address
673 Nitonacho, Chuo-ku, Chiba-shi, Chiba
TEL
0433051888
iizaka.tky@gmail.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Iizaka |
Organization
Shukutoku university
Division name
College of Nursing and Nutrition
Zip code
260-8703
Address
673 Nitonacho, Chuo-ku, Chiba-shi, Chiba
TEL
0433051888
Homepage URL
iizaka.tky@gmail.com
Sponsor or person
Institute
Shukutoku university
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of College of Nursing and Nutrition of Shukutoku University
Address
673 Nitonacho, Chuo-ku, Chiba-shi, Chiba
Tel
043-305-1881
shinji.iizaka@soc.shukutoku.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 | 04 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061914
