{
  "abstract": "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. This paper presents the protocol for the STRONGER 60+trial, which aims 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 randomised 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 80 participants will be randomised to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same programme. 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-randomisation. 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.Ethics and dissemination The study has been approved by the Swedish Ethical Review Authority (approval numbers: 2020–05785, 2021–06413-02, 2022–05454-02) and will follow the principles of the Declaration of Helsinki. Ethical procedures for informed consent, confidentiality and data management will be strictly observed. Results will be disseminated through scientific publications, conferences and targeted outreach to healthcare professionals and the general public.Trial registration number NCT07117916.",
  "authors": [
    {
      "affiliations": [
        "Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden",
        "Women′s Health and Allied Health Professionals Theme, Medical Unit Medical Psychology, Karolinska University Hospital, Stockholm, Sweden",
        "Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Stockholm County, Sweden"
      ],
      "name": "Anna-Karin Welmer"
    },
    {
      "affiliations": [
        "Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden",
        "Research and Development Unit, Stockholms Sjukhem, Stockholm, Stockholm County, Sweden"
      ],
      "name": "Breiffni Leavy"
    },
    {
      "affiliations": [
        "Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden",
        "Theme Inflammation and Aging, Nursing Unit Aging, Karolinska University Hospital, Stockholm, Sweden",
        "Department of Caring Sciences, Faculty of Health and Occupational Studies, University of Gävle, Gävle, Sweden"
      ],
      "name": "Charlotta Thunborg"
    },
    {
      "affiliations": [
        "Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden"
      ],
      "name": "Jasper Holleman"
    },
    {
      "affiliations": [
        "Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden"
      ],
      "name": "Patrik Karlsson"
    },
    {
      "affiliations": [
        "Research and Development Unit, Stockholms Sjukhem, Stockholm, Stockholm County, Sweden"
      ],
      "name": "Helena Hallinder"
    },
    {
      "affiliations": [
        "Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden",
        "Theme Inflammation and Aging, Nursing Unit Aging, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Malin Aspö"
    },
    {
      "affiliations": [
        "Research and Development Unit, Stockholms Sjukhem, Stockholm, Stockholm County, Sweden"
      ],
      "name": "Caroline Bergström"
    },
    {
      "affiliations": [
        "Research and Development Unit, Stockholms Sjukhem, Stockholm, Stockholm County, Sweden",
        "Division of Neurogeriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Stockholm County, Sweden"
      ],
      "name": "Elisabet Åkesson"
    },
    {
      "affiliations": [
        "Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden",
        "Faculty of Social Sciences (Health Sciences) and Gerontology Research Center (GEREC), Tampere University, Tampere, Finland",
        "Department of Public Health, Finnish Institute for Health and Welfare, Helsinki, Uusimaa, Finland"
      ],
      "name": "Jenni Kulmala"
    },
    {
      "affiliations": [
        "Research and Development Unit, Stockholms Sjukhem, Stockholm, Stockholm County, Sweden",
        "Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden",
        "Theme Inflammation and Aging, Nursing Unit Aging, Karolinska University Hospital, Stockholm, Sweden",
        "Division of Neurogeriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Stockholm County, Sweden"
      ],
      "name": "Miia Kivipelto"
    }
  ],
  "title": "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",
  "uid": "4d1a8a8a-4148-5f8a-8d65-7c086d1b8d01"
}