UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060226 |
|---|---|
| Receipt number | R000068870 |
| Scientific Title | Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/26 16:15:54 |
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Basic information
Public title
Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial
Acronym
Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial
Scientific Title
Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Community-dwelling adults aged 60 to 80 years without dementia who are identified as having hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) or hyperglycemia (HbA1c >=6.5%).
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of a community-based multidomain intervention program in preventing the progression of cognitive impairment over a 12-month period among community-dwelling older adults at risk for dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in MoCA-J score from baseline to the 12-month follow-up.
Key secondary outcomes
1) Changes in cognitive function (Nou-Know, MIRUDAKE) from baseline to 6, 12, and 24 months.
2) Changes in frailty status from baseline to 6, 12, and 24 months.
3) Changes in physical function (grip strength, gait speed, one-leg standing time) and physical activity levels from baseline to 6, 12, and 24 months.
4) Changes in dietary diversity score from baseline to 6, 12, and 24 months.
5) Changes in depressive symptoms (GDS) from baseline to 6, 12, and 24 months.
6) Changes in health-related quality of life (EQ-5D) from baseline to 6, 12, and 24 months.
7) Changes in health check-up results from screening to 12 months
8) Acceptability of the intervention, class attendance rate, and transition rate to self-organized groups at the end of the program
9) Changes in blood biomarkers from baseline to 12 months.
10) Cost-effectiveness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Two sets of the 6-month community-based J-MINT program (a multidomain intervention including exercise, nutrition, cognitive training, social participation, and vascular risk management) will be provided during the intervention period.
Interventions/Control_2
Participants in the control group will receive usual care and general health information provided by the municipality. No structured multidomain intervention program will be 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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 60 to 80 years at the time of enrollment
2) Individuals with vascular risk factors, defined as hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) or hyperglycemia (HbA1c >=6.5%)
3) Individuals with a total score of 22 to 30 on the Dementia Assessment Sheet in Community-based Integrated Care System - 21 items (DASC-21)
4) Individuals who receive a full explanation of the study using the written informed consent form and provide written informed consent.
Key exclusion criteria
1) Individuals with severe functional impairment requiring prohibition or restriction of physical activity or dietary/fluid intake (including musculoskeletal disorders, renal failure, ischemic heart disease, or cardiopulmonary dysfunction).
2) Individuals with systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg
3) Individuals with a diagnosed dementia
4) Individuals who are unable to communicate in Japanese
5) Individuals who are unable to undergo cognitive or physical assessments
6) Individuals who have been certified as needing long-term care at level 1 or higher under the Japanese Long-Term Care Insurance system
7) Individuals with a history of major depressive disorder, bipolar disorder, schizophrenia, alcohol dependence, drug dependence, or with unstable or severe medical conditions
8) Individuals deemed unsuitable for participation by their attending physician due to concerns such as potential worsening of underlying medical conditions
Target sample size
680
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakurai |
Organization
National Center for Geriatrics and Gerontology
Division name
Research Institute
Zip code
4748511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562462311
tsakurai@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Sugimoto |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Prevention and Care Science
Zip code
4748511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562462311
Homepage URL
taiki-s@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Medical Division, National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562462311
yaday@ncgg.go.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
| 2026 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068870
