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

N/ANot Yet RecruitingNCT07117916

Karolinska Institutet96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Older Adults at High Risk for MCI

Interventions

Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.BEHAVIORAL

In addition to health advice, participants in the intervention group will receive a structured, multidomain lifestyle program comprising nutritional guidance, physical exercise, cognitive training and social engagement, and monitoring and management of vascular and metabolic risk factors. The STRONGER 60+ intervention is based on the FINGER protocol and has been specifically adapted for primary care to enhance feasibility and scalability. Key adaptations include 1) delivering physical exercise sessions at external gym facilities rather than at primary care centers, and 2) shortening the intervention duration from two years to six months.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Individuals aged 60 and older who express interest in the study will be pre-screened by the research team using the CAIDE (Cardiovascular Risk Factors, Aging, and Dementia) Risk Score. Those scoring ≥6-indicating elevated dementia risk-will be invited for an in-person screening visit to confirm eligibility. The CAIDE score (range: 4-15) is based on age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity. Additional inclusion criteria are a Mini-Mental State Examination (MMSE) score of ≥24, and ability to walk independently indoors and outdoors (with or without a mobility aid). Exclusion Criteria: Exclusion criteria include diagnosed dementia and residence in a nursing home.

Outcomes

Primary Outcomes

Composite healthy lifestyle score

The primary outcome is a composite healthy lifestyle score based on four domains measured individually: dietary intake (Mediterranean Diet Adherence Screener ), physical activity (ActiGraph), cognitive and social engagement (combined self-reported), and cardiovascular risk burden (BMI, lipids, glucose, waist-to-hip ratio, and smoking status).

Time frame: Assessments are conducted at baseline, 6 months (primary endpoint), and 12 months post-randomization

Secondary Outcomes

Functioning and symptoms

Physical function by Short Physical Performance battery (SPPB) and 10 meter walking test, Cognitive function by Mini Mental State Examination (MMSE), Geriatric Depression Scale (GDS15), Health Related Quality of Life (RAND-36), Pittsburg Sleep Quality Index (PSQI)

Time frame: Baseline, 6- and 12 months post randomization