STRONGER 60+: Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care

Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. The aim of the STRONGER 60+ trial is to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care. Methods and analysis: This 6-month randomized controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 96 participants will be randomized to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same program. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint), and 12 months post-randomization. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.

NCT Number	NCT07117916
Lead Sponsor	Karolinska Institutet Collaborators: Stiftelsen Stockholms Sjukhem
Conditions	Older Adults at High Risk for MCI, Older Adults With Mild to Moderate Level of Dementia
Enrollment	80 participants
Start Date	2026-08-01
Primary Completion	2028-02 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-03-27