UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056396 |
|---|---|
| Receipt number | R000064433 |
| Scientific Title | A Randomized Controlled Trial Using an App to Improve Diet Quality and Prevent Frailty Through Social Connection Building in Older Adults |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2024/12/08 22:17:59 |
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Basic information
Public title
Evaluation of the Effectiveness of an App for Improving Diet Quality and Preventing Frailty in Older Adults
Acronym
Evaluation of the Effectiveness of a Dietary Improvement App for Older Adults
Scientific Title
A Randomized Controlled Trial Using an App to Improve Diet Quality and Prevent Frailty Through Social Connection Building in Older Adults
Scientific Title:Acronym
A Randomized Controlled Trial Utilizing an App to Improve Diet Quality and Prevent Frailty in Older Adults
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of an intervention using an App to promote social connection on improving dietary quality and preventing frailty in older adults.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diet quality/ Frailty
Key secondary outcomes
Skin carotenoid score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A three-month intervention involving:
- Social interaction among participants through sharing meal photos via a smartphone app
- Providing dietary advice
Interventions/Control_2
No intervention implemented
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Independent older adults
Ownership of a smartphone
Key exclusion criteria
Individuals requiring nursing care or support
Those consuming special therapeutic diets
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Kurotani |
Organization
Showa Women's University
Division name
Graduate School of Life Sciences
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
TEL
0334116257
k-kurotani@swu.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Kurotani |
Organization
Showa Women's University
Division name
Graduate School of Life Sciences
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
TEL
0334116257
Homepage URL
k-kurotani@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
Funding Source
Organization
Lotte Research Promotion Grant
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee of Showa Women's University
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
Tel
03-3411-7351
kenkyu@swu.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
| 2025 | Year | 11 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064433
