UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062928 |
|---|---|
| Receipt number | R000072048 |
| Scientific Title | Exploratory Study on Frailty Risk Prediction and Lifestyle Improvement Effects in Older Adults Using a Digital Tool |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/15 11:38:18 |
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Basic information
Public title
A Study on Frailty Risk Prediction and Lifestyle Improvement in Older Adults Using a Digital Tool
Acronym
Kawasaki rRAFU Study
Scientific Title
Exploratory Study on Frailty Risk Prediction and Lifestyle Improvement Effects in Older Adults Using a Digital Tool
Scientific Title:Acronym
Kawasaki rRAFU Study
Region
| Japan |
Condition
Condition
Risk of future undernutrition and frailty in community-dwelling older adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory assessment of future undernutrition and frailty risk and changes before and after implementation of lifestyle improvement plans
Basic objectives2
Others
Basic objectives -Others
Exploratory assessment of future undernutrition and frailty risk and changes before and after implementation of lifestyle improvement plans
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the rRAFU questionnaire score from baseline to 3 months
Key secondary outcomes
Changes in body composition from baseline to 3 months; comparison of rRAFU scores and body composition according to implementation of lifestyle improvement plans; changes by sex and age group; and selection, implementation and continuation of lifestyle improvement plans and app usage.
Base
Study type
Observational
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Residents of Kawasaki City aged 60 years or older at the time of informed consent.
2.Individuals who have received sufficient explanation of the purpose and procedures of the study, are capable of providing informed consent, fully understand the study, and voluntarily agree to participate.
Key exclusion criteria
1.Individuals who are unable to understand written information or are unable to read and write.
2.Individuals who may be unable to accurately complete the questionnaire.
3.Individuals with implanted metallic medical devices, such as pacemakers or implantable cardioverter-defibrillators, or with artificial femoral heads, metal plates, or similar devices.
4.Individuals with marked difficulty walking who cannot safely perform light exercise such as walking.
5.Individuals judged by the principal investigator to be inappropriate for participation in the study for any other reason.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakamura |
Organization
Meiji Co., Ltd.
Division name
Health Science Research Unit, Nutrition and Physiological Chemistry Research Group
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5847
kentarou.nakamura@meiji.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Aoki |
Organization
Kawasaki City
Division name
Planning and Coordination Division, Urban Policy Department, General Affairs and Planning Bureau
Zip code
210-8577
Address
1 Miyamoto-cho, Kawasaki-ku, Kawasaki, Kanagawa 210-8577, Japan
TEL
044-200-2166
Homepage URL
aoki-r@city.kawasaki.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kawasaki City
Fujitsu Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
川崎市内のいこい元気広場実施会場（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 15 | 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
166
Results
Of 166 baseline participants, 78 completed 3 months. In 65 with paired rRAFU data, the score changed from 2.60 +/- 2.16 to 2.17 +/- 1.61 (change -0.43, 95% CI -0.87 to 0.01, p=0.056). In 54 with paired body composition data, body fat percentage fell from 30.42 +/- 6.40% to 29.56 +/- 6.37% (p<0.001). Among 77 app users, plan selection was 89.6%, use at least once 71.4%, and use on at least 5 days 45.5%. No adverse events occurred.
Results date posted
| 2026 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline n=166. Mean age was 76.3 +/- 7.1 years (n=134). There were 112 women, 23 men, and 31 with missing sex information. Mean baseline rRAFU score was 2.69 +/- 2.08 (n=143).
Participant flow
The target sample size was 240 participants. A total of 166 participants completed the baseline assessment, and 78 completed the 3-month assessment. The FAS included 166 participants and the PPS included 54 participants. The analysis sets included 65 participants for paired rRAFU analysis, 54 for paired body composition analysis, and 77 for app usage analysis.
Adverse events
No study-related adverse events or serious adverse events were reported.
Outcome measures
[Primary outcome]
Among 65 participants with paired data, the mean rRAFU score was 2.60 +/- 2.16 at baseline and 2.17 +/- 1.61 at 3 months, with a mean change of -0.43 points (95% CI -0.87 to 0.01; p=0.056, paired t-test). Thirty participants improved, 18 remained unchanged, and 17 worsened.
[Secondary outcomes]
Among 54 participants with paired body composition data, fat-free mass changed from 36.28 +/- 6.72 kg to 36.36 +/- 6.71 kg (change +0.08 +/- 0.81 kg; p=0.62), SMI from 5.88 +/- 0.90 kg/m2 to 5.96 +/- 0.91 kg/m2 (change +0.08 +/- 0.32 kg/m2; p=0.08), and body fat percentage from 30.42 +/- 6.40% to 29.56 +/- 6.37% (change -0.86 +/- 1.45 percentage points; p<0.001). Among 77 app users, plan selection was 89.6%, use at least once 71.4%, and use on at least 5 days 45.5%.
Plan to share IPD
There is no plan to share individual participant data (IPD) with external researchers.
IPD sharing Plan description
Data obtained in this study will be appropriately managed and stored in accordance with the study protocol. There is no plan to provide or publicly share individual participant data with external researchers.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 03 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 28 | Day |
Other
Other related information
This is a prospective observational study of community-dwelling adults aged 60 years or older residing in Kawasaki City. No group allocation or randomization was performed. At baseline, future risk of undernutrition and frailty was assessed using the rRAFU questionnaire, and body composition was measured. Lifestyle improvement plans related to physical activity, diet, and social participation were presented according to the rRAFU score, and participants voluntarily selected and implemented these plans. The rRAFU questionnaire and body composition measurements were repeated after 3 months. Changes in rRAFU scores and body composition, selection, implementation and continuation of lifestyle improvement plans, and use of the web-based system were evaluated exploratorily. Participants were recruited with the cooperation of Kawasaki City and enrolled after eligibility confirmation.
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072048
