UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062264 |
|---|---|
| Receipt number | R000071250 |
| Scientific Title | Effects of a Comprehensive Oral Frailty Prevention Program Targeting Behavioral Change in Oral Health, Mastication, and Nutrition in a Super-Aged Rural Mountain Community: A Multi-Site Pre-Post Study in Chizu Town, Japan |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 10:23:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicomponent Behavioral Intervention for Oral Frailty Prevention in Older Adults of Chizu Town, Japan
Acronym
Multicomponent Behavioral Intervention for Oral Frailty Prevention in Older Adults of Chizu Town, Japan
Scientific Title
Effects of a Comprehensive Oral Frailty Prevention Program Targeting Behavioral Change in Oral Health, Mastication, and Nutrition in a Super-Aged Rural Mountain Community: A Multi-Site Pre-Post Study in Chizu Town, Japan
Scientific Title:Acronym
Effects of a Comprehensive Oral Frailty Prevention Program Targeting Behavioral Change in Oral Health, Mastication, and Nutrition in a Super-Aged Rural Mountain Community: A Multi-Site Pre-Post Study in Chizu Town, Japan
Region
| Japan |
Condition
Condition
Oral frailty (prevention among community-dwelling older adults)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims (1) to evaluate the feasibility and preliminary effects of a comprehensive oral frailty prevention program targeting behavioral change in oral health, mastication, and nutrition - on oral frailty (the primary outcome) and on oral function, dietary variety, physical function, and health-related quality of life (secondary outcomes) - among community-dwelling older adults in Chizu Town, and (2) to explore the program's cost-effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral frailty assessed using the Oral Frailty Index-8 (OFI-8), at baseline (0 months), post-intervention (3 months), and annually at years 1 to 5.
Key secondary outcomes
Oral diadochokinesis (ODK), Dietary Variety Score (DVS), grip strength, and health-related quality of life (HRQOL; EQ-5D-5L), assessed at baseline (0 months), post-intervention (3 months), and annually at years 1 to 5. Participant satisfaction (5 items: program comprehensibility, overall satisfaction, willingness to participate again, likelihood of recommending the program, and motivation for behavior change in dietary and oral health practices), assessed at 3 months and annually at years 1 to 5 (6 times in total). Long-term outcomes (administrative data, up to 10 years): long-term care certification and care-need level changes, hospitalization for pneumonia (including aspiration pneumonia), residential status, and vital status.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A community-adapted version of the CAMCAM program (developed by Professor Koichiro Matsuo, Institute of Science Tokyo): a three-component combined intervention targeting behavioral change in oral health, mastication, and nutrition. Year 1: four monthly group sessions (approximately 2 hours each) at community centers or other local gathering places. In every session, participants eat the CAMCAM textured lunch - a textured meal designed to promote chewing - and receive education aligned with that session's theme. The 4 sessions cover, in order, an introduction to the link between healthy longevity and oral health, mastication, and nutrition; nutrition and dietary variety; oral health and mastication; and a review of the whole program for integration into daily life. Year 2 onward: an annual consolidated session (approximately 2 to 3 hours) repeated 5 times, for a total of 5 years of in-person delivery per district.
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
Community-dwelling adults aged 60 years or older residing in Chizu Town who intend to attend all four program sessions and provide written informed consent (primary target population: aged 65 or older, with a planned subgroup analysis).
Key exclusion criteria
(1) Certification at Long-Term Care Insurance Care Level 3 or above; (2) serious medical conditions (eg, malignancy or severe cardiac disease) that preclude participation; (3) being judged by the investigator to lack the capacity to provide informed consent (eg, due to dementia); (4) plans to relocate or move to a care facility during the study period.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Kubo |
Organization
National Health Insurance Chizu Hospital
Division name
Department of Dentistry
Zip code
689-1402
Address
1875 Chizu, Chizu-cho, Yazu-gun, Tottori 689-1402, Japan
TEL
0858-75-3211
chizu.research2026kubo@gmail.com
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Kubo |
Organization
National Health Insurance Chizu Hospital
Division name
Department of Dentistry
Zip code
689-1402
Address
1875 Chizu, Chizu-cho, Yazu-gun, Tottori 689-1402, Japan
TEL
0858-75-3211
Homepage URL
chizu.research2026kubo@gmail.com
Sponsor or person
Institute
National Health Insurance Chizu Hospital
Institute
Department
Personal name
Funding Source
Organization
Chizu Town
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Foundation (PHRF) Ethics Review Committee
Address
1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo 169-0051, Japan
Tel
03-5287-5070
N/A
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
国民健康保険智頭病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | 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
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
No
IPD sharing Plan description
The datasets generated and analyzed during this study will not be publicly available, because participant consent does not include public data sharing and because individual-level data from a small, super-aged community could be identifiable. Deidentified aggregate data may be made available by the corresponding author upon reasonable request, subject to approval by the PHRF Ethics Review Committee.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2038 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071250
