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Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial

Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial - Effectiveness of the Community-Based J-MINT Brain Health Program: A Cluster Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060226
Enrollment
680
Registered
2026-01-01
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-dwelling adults aged 60 to 80 years without dementia who are identified as having hypertension (systolic blood pressure &gt

Interventions

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 provid

Sponsors

National Center for Geriatrics and Gerontology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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 a diagnosed dementia 3) Individuals who are unable to communicate in Japanese 4) Individuals who are unable to undergo cognitive or physical assessments 5) Individuals who have been certified as needing long-term care at level 1 or higher under the Japanese Long-Term Care Insurance system 6) Individuals with a history of major depressive disorder, bipolar disorder, schizophrenia, alcohol dependence, drug dependence, or with unstable or severe medical conditions 7) Individuals deemed unsuitable for participation by their attending physician due to concerns such as potential worsening of underlying medical conditions

Design outcomes

Primary

MeasureTime frame
Change in MoCA-J score from baseline to the 12-month follow-up.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTaiki Sugimoto

National Center for Geriatrics and Gerontology Department of Prevention and Care Science

taiki-s@ncgg.go.jp0562462311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026