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

Официальное название

STRONGER 60+: Study Protocol for a Mixed-methods Randomized Controlled Trial Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care

Обзор

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.

Вмешательства

• Поведенческое Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.
  The structured multidomain lifestyle intervention (intervention group) In addition to health advice, participants in the intervention group will receive a structured, multimodal lifestyle program comprising nutritional guidance, physical exercise, cognitive training and social engagement, and monitoring and management of vascular and metabolic risk factors. The nutritional component consists of one group session and two individual counseling sessions with the study dietician. The physical exerci
• Поведенческое Self-Guided
  The self-guided intervention (control group) Participants in the control group will receive a self-guided version of the intervention. All participants, regardless of group allocation, will meet with the study nurse at screening, baseline, and six months post-randomization for health assessments. These assessments will include blood sampling, blood pressure, weight, body mass index (BMI), and hip and waist circumference. A medical history and physical examination will be performed by the study n

Первичные конечные точки

• Composite healthy lifestyle score [Срок оценки: Assessments are conducted at baseline, 6 months (primary endpoint), and 12 months post-randomization]

Вторичные конечные точки (1)

• Changes in functioning and symptoms [Срок оценки: Baseline, 6- and 12 months post randomization]

Критерии участия

Критерии включения

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).

Критерии исключения

Exclusion criteria include diagnosed dementia and residence in a nursing home.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Welmer AK, Leavy B, Thunborg C, Holleman J, Karlsson P, Hallinder H, Aspo M, Bergstrom C, Akesson E, Kulmala J, Kivipelto M. STRONGER 60+: study protocol for a mixed-methods randomised controlled trial assessing the clinical effectiveness and delivery of an adapted FINGER model for brain health in primary care. BMJ Open. 2026 Apr 13;16(4):e111346. doi: 10.1136/bmjopen-2025-111346. PMID 41974549

Идентификаторы

NCT: NCT07117916 · 2023-01125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗