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NCT Number: NCT07661472

The FINGER Model - Preventing Cognitive Decline and Promoting Health of Older People.

Cognitive impairment and dementia can cause considerable suffering, both for the person affected and for next of kin. They also pose major challenges for health and social care. At the same time, research shows that many risk factors for cognitive decline can, in fact, be influenced. This is particularly the case when several areas are addressed simultaneously, such as physical activity, healthy eating habits, mental stimulation, social connectedness, and good cardiovascular health. A well-known model for such a multidomain preventive intervention is the FINGER model: the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability. In the randomized controlled FINGER study, the results showed that a two-year programme comprising diet, exercise, cognitive training, social activity, and structured monitoring of vascular risk factors could improve and maintain cognitive function among older people at increased risk of cognitive decline. However, the research evidence is not unequivocal. Other randomized studies found no effect on cognitive outcomes over three years in the studied population, and in a cluster-randomized study reported no clear effects on the incidence of dementia in the older population. In addition, studies are needed that follow changes when the model is implemented in clinical practice. In recent years, the FINGER model has also been adapted and tested in several countries through the FINGER network, with the aim of developing and evaluating interventions that work in different contexts, while also strengthening knowledge and enabling comparisons of results between countries. A recently published qualitative study showed that participants were often motivated by an expectation of personal benefit, both for brain health and physical health, but also by concerns about cognitive decline. Social aspects also played an important role, as did the need for the interventions to feel understandable and for lifestyle changes to be perceived as realistic and feasible in everyday life.

The overall aim of the project is to evaluate a municipality-initiated, health-promoting multicomponent programme, based on the FINGER model, for older people, with a focus on health, health-related quality of life, well-being, and lifestyle habits (group A), and to compare it with a programme with fewer components (group B) implemented in the municipality. Furthermore, the aim is to explore older people's experiences of participating in the project, as well as how older people in the study rate their health and well-being before, during, and after completing their participation in the project.

The main research questions are:

* How do older people rate their health, health-related quality of life, well-being, and lifestyle habits before, during, and after participation in the municipality's project (groups A and B)? * What cognitive and physical functional ability do older people have before, during, and after participation in the municipality's project (group A)? * Are there any differences over time within each group (A and B), and are there any differences over time between the groups in the project? * Do self-rated health and health-related quality of life in this study population differ from the values reported in a previously published study? * How do older people experience participating in the project (group A)?

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Key information

Conditions

Older People Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Quasi-experimental design with two groups (A and B), including baseline measurements (T0) and follow-up measurements (T1-T3), as well as a descriptive qualitative interview study in group A (the FINGER model).

Group A*, referred to by the municipality as "Hjärngänget": The municipality's project, which is inspired by the FINGER model, is based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors. This part is carried out entirely by the municipality, on its own initiative regardless of whether research is conducted or not, and is not influenced in any way by the researchers. A more detailed description of the programme for group A is provided below:

Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning.

Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health.

Diet: a lecture on diet and two practical workshops. Social interaction: a coffee/social gathering in connection with the group exercise session, as well as support in finding associations and activities.

Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision.

Supportive counselling: advisory health conversations and three individual sessions with a health educator focusing on behaviour change and motivation.

Group B*, referred to by the municipality as "Hjärncellskapet": Group B will be recruited from the same target population, through the same channels and using the same selection criteria, but will receive a less extensive intervention. Group B will be offered participation in five lectures related to the five FINGER components.

The selection of participants for group A will comprise approximately 15 people who are assessed as having the highest number of risk factors for cognitive decline. Others who have expressed interest will be invited to participate in group B. In addition to the municipality's inclusion criteria, the research study requires that participants in group A are able to take part in an interview in Swedish, complete a questionnaire, and provide informed consent. For group B, participants must be able to complete a questionnaire and provide informed consent. FINGER model, group A: round 1, approximately 15 participants (2026); round 2, approximately 15 participants (2027); and round 3, approximately 15 participants (2027). Group B: round 1, approximately 55 participants (2026); round 2, approximately 40 participants (2027); and round 3, approximately 40 participants (2027).

Data analysis: Quantitative data will be analyzed using descriptive statistics and analytical statistics. Effects between groups will be analyzed using ANCOVA and, where appropriate, GEE. Comparisons with published reference data will be conducted using one-sample t-tests. For non-normally distributed data, corresponding non-parametric methods will be used. Analyses will be performed in IBM SPSS Statistics. Interview data will be analyzed using qualitative inductive content analysis. The analysis aims to identify categories that describe experiences of participation, involvement, barriers and facilitators, and perceived meaning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • older person is 65 years or older, registered as a resident in Bollnäs Municipality, and responds to questions about lifestyle habits, well-being, memory, and cardiovascular diseases. Participants must also be able to take responsibility for their own transport to and from physical meetings, have access to their own digital device, such as a smartphone, computer, or iPad, and have the time and opportunity to attend weekly sessions over a period of nine months. For participation in the research study, participants must also be able to take part in an interview in Swedish, complete a questionnaire, and provide informed consent. For participants who are only included in the questionnaire-based part of the study, the criteria are the ability to complete a questionnaire and provide informed consent.

Exclusion criteria

  • if the person has cognitive impairment or dementia to such an extent that an interview is not considered possible or ethically appropriate, has pronounced communication difficulties that make an interview impossible, and/or requires an interpreter.

Treatment and study plan

FINGER model

Other

The FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors:

  • Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning.
  • Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health.
  • Diet: a lecture on diet and two practical workshops.
  • Social interaction: a social gathering in connection with the group exercise session, as well as support in finding associations and activities.
  • Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision
  • Supportive counselling

Primary outcomes

  1. Older peoples' rating of their health, well-being, and functional ability in everyday life.

    Time frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

    Survey, RAND-36 with 8 dimensions: Physical Function, Role Physical, Role mental, Vitality, Mental Health, Social Function, Bodily Pain, and General Health with scores 0-100, higher scores a more desirable outcome for wellbeing.

Secondary outcomes

  1. Older peoples' rating of their health/wellbeing

    Time frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

    Survey, scale for health EUROQOL VISUAL ANALOGUE SCALE (EQ-VAS), scores 0-100, higher scores better health.

  2. Older peoples' rating of their health/wellbeing - Loneliness

    Time frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

    The UCLA 3-item loneliness scale will be used to measure loneliness. Higher scores indicating more loneliness. Each item rated on a 3-popint scale 1)hardly ever 2) some of the time, 3) often. Total score of the scale is the sum of the three items ( scale range 3-9).

  3. Older peoples' rating of their health/wellbeing - Depression and anxiety

    Time frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

    Survey, the Patient Health Questionnaire PHQ-4 will be used that gives a score for nervous, worried or stressed, not being able to stop worrying or control your worries, little interest or joy of doing things and felt low, depressed, or experienced feelings of hopelessness, scored between 0-3, higher score more depressive symptoms, each item rated from 0 ( "not at all") to 3 ( "nearly every day").

Other outcomes

  1. Older peoples' rating of their cognitive function

    Time frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention and 6 months after T0 (T3).]

    Clock test, The person draws the clock face themselves, and then adds the numbers and hands. The time shown by the hands should be 10 minutes past 11.

    Different scoring methods have been described. One common way of scoring is 0-4 points, as follows:

    • Draws a clock face in the form of a closed circle: 1 point
    • Places the numbers in the correct positions: 1 point
    • Includes all 12 correct numbers: 1 point
    • Places the hands in the correct positions: 1 point A person with normal cognitive function should be able to draw the clock without difficulty and receive 4 points. Clinical judgement must be applied, but a low score, lower than 4, indicates the need for further assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Annakarin Olsson, Associate professor, PhD

CONTACT

[email protected]

0046730552625

Maria Engström, Professor, PhD

CONTACT

[email protected]

004626648215

Sponsors and collaborators

Lead sponsor

University of Gavle

Other

Registry information

Official study title

The FINGER Model for Preventing Cognitive Decline and Promoting Health - Older Peoples' Perspectives on Participating in the Projects "Hjärngänget" and "Hjärncellskapet" - a Pathway to Better Health.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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