Family FINGER: Lifestyle Intervention Among Older Caregivers

Family FINGER: a Pilot Randomised Controlled Trial of Healthy Lifestyle Intervention Versus Standard Care Among Older Caregivers

The Family FINGER study enrolls caregivers aged 65 or older who live with and care for a spouse with cognitive impairment in North Savo, Finland (estimated n=100). This intervention builds on the FINGER study, which showed improved cognitive performance and health benefits, including better health-related quality of life. The intervention will be tailored to meet caregivers' specific needs.

The overall aim of the Family FINGER trial is to assess the efficacy of this intervention on the positive mental health of spousal caregivers.

Specific research questions are as follows:

1. What is the efficacy of the Family FINGER intervention on mental health?
2. What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?

Study Overview

• Status: Not yet recruiting
• Conditions: Positive Mental Health
• Intervention / Treatment: Behavioral: a multidomain lifestyle intervention

Detailed Description

Background:

This study applies the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) intervention model among family caregivers.

Study design:

Randomised, controlled, parallel-group, single-centre pilot trial testing the efficacy of the multidomain Family FINGER lifestyle intervention on positive mental health versus standard care.

Recruitment:

Up to 100 spousal family caregivers aged 65 and older who are caring for a spouse with cognitive impairment and live in the same household will be recruited from Northern Savo, Finland. Interested participants will be screened for eligibility. Eligible participants will undergo baseline assessments and will be randomised 1:1 to either the Family FINGER intervention (intervention group) or standard care (control group).

The aim and outcomes:

The primary aim of the Family FINGER trial is to test a multimodal lifestyle intervention and evaluate its effect on positive mental health. Primary comparison time point for positive mental health is at 12 months.

Secondary outcomes will focus on broader effects, including dementia risk and cognitive functioning, and various assessments of lifestyle, diet, physical activity, cognitive and social activities. In addition, the trial will assess factors including stress levels, general health, depressive symptoms, social inclusion, and quality of life. Medical history, health status, and nutrition will also be evaluated.

Furthermore, anthropometric measurements and other lifestyle-related dementia risk factors such as smoking, alcohol consumption, cholesterol levels, HbA1c, physical activity, and performance will be considered. Other assessments include feasibility (i.e., recruitment rate, retention, intervention adherence) and qualitative interviews.

Intervention:

The intervention includes physical activities, social activities, cognitive training, cardiovascular risk management, and nutritional guidance. The dietary intervention will be based on Finnish national guidelines and include individual and group visits. The exercise intervention includes at least weekly supervised and independent aerobic, strength, and balance training. The training will be progressive in resistance level, duration, and frequency. Cognitive training includes individual and/or group-based sessions and independent digital cognitive training. Vascular risk management intervention includes assessment and consultation regarding diet, blood pressure, blood lipids, glucose levels, body weight, smoking, and alcohol consumption. All interventions will be delivered by trained study staff. Interventions are tailored according to the participant's health status and/or functional limitations, and both in-person and remote options are considered for intervention delivery.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tarja Välimäki, PhD; Phone Number: +358 40 355 2267; Email: tarja.valimaki@uef.fi
• Study Contact Backup: Name: Tiia Ngandu, MD, PhD; Phone Number: 0295247716; Email: tiia.ngandu@thl.fi

Study Locations

• Finland
  • Kuopio, Finland, 70210
    • Department of Nursing Science
    • Contact: Tarja Välimäki, PhD; Phone Number: +358 40 355 2267; Email: tarja.valimaki@uef.fi
    • Principal Investigator: Tarja Välimäki, PhD
    • Principal Investigator: Tiia Ngandu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 65 and older.
• Caregiver for a spouse with cognitive impairment.
• Live in the same household with the care recipient.
• The presence of modifiable risk factors for health: at least one self-reported lifestyle-related risk factor, or self-reported CAIDE dementia risk scores of 6 or higher, or a self-reported burdensome caregiving situation.

Exclusion Criteria:

• A medication for Alzheimer's disease or diagnosis of dementia or suspected dementia (such as referral to or ongoing assessment process at memory clinic, or MoCa < 18 points).
• Any health condition affecting safe engagement in the intervention, or the caregiving situation is such that specialised social or health care services are needed before safe engagement in the intervention can be ensured, according to clinical judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Experimental: Healthy Lifestyle Intervention	Behavioral: a multidomain lifestyle intervention; The intervention includes physical activities, social activities, cognitive training, cardiovascular health management, and dietary guidance. The exercise intervention includes at least weekly supervised and independent training in aerobic, strength, and balance exercises, along with social activities. The training will be progressive in resistance level, duration, and frequency. Cognitive training encompasses individual and/or group-based sessions, as well as independent digital cognitive training. Vascular risk management interventions include assessments and consultations regarding blood pressure, blood lipids, glucose levels, body weight, smoking, and alcohol consumption. The dietary intervention will be based on national guidelines and include individual and group visits. All interventions will be delivered by trained study staff. Interventions are tailored according to the participant's health status, caregiving situation, and/or functional limitations.; Other Names: Family FINGER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)	Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing. Primary comparison at 12-months with extended 6-month follow-up.	Baseline, 6 months, 12 months, and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in healthy lifestyle	Composite Healthy Lifestyle Index score (range 0-24), including diet, physical activity, smoking, alcohol use, and cognitive/social activities. Higher scores indicate a healthier lifestyle. Primary comparison at 12-months with extended 6-month follow-up.	Baseline, 12 months and 18 months
Change from baseline in dementia risk (LIBRA score)	Lifestyle for Brain Health (LIBRA) index score (theoretical range -5.9 to +12.7). Lower scores indicate a healthy lifestyle and lower estimated dementia risk.	Baseline and 12 months
Change from baseline in dementia risk (CAIDE score)	Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points). Lower scores indicate lower dementia risk.	Baseline and 12 months
Change from baseline in cognitive function (MoCA score)	Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.	Baseline and 12 months
Change from baseline in dietary intake	Dietary quality assessed using the adapted FINGER Diet Index (range 0-9). Higher scores indicate better adherence to dietary recommendations.	Baseline and 12 months
Change from baseline in physical activity frequency (sessions/week)	Number of moderate-to-vigorous physical activity sessions per week. Higher values indicate greater physical activity.	Baseline and 12 months
Change from baseline in physical activity	Self-reported physical exercise in the previous two weeks, using a modified version of the Minnesota Leisure Time Physical Activity Questionnaire, expressed as total duration of physical activity (minutes/week). Higher levels of physical activity indicate a better outcome.	Baseline and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (retention rate)	Proportion of randomized participants completing the 12-month assessment. Higher percentages indicate better retention.	12 months
Feasibility (qualitative evaluation)	Qualitative interviews assessing feasibility and acceptability of the intervention.	Baseline and 12 months
Change from baseline in objectively measured physical activity (Actigraph)	Physical activity measured using a wrist-worn accelerometer over 7 consecutive days, reported as time spent in physical activity (e.g., minutes/day). Higher values indicate greater physical activity.	Baseline and 12 months
Change from baseline in instrumental activities of daily living (IADL score)	Instrumental Activities of Daily Living (IADL) score (range 0-8). Higher scores indicate greater independence.	Baseline, 12 months and 18 months
Change from baseline in activities of daily living (Barthel Index score)	Barthel Index score (range 0-100). Higher scores indicate greater independence in daily activities.	Baseline, 12 months and 18 months
Change from baseline in physical performance (SPPB score)	Short Physical Performance Battery (SPPB) total score (range 0-12). Higher scores indicate better lower extremity function.	Baseline and 12 months
Change from baseline in hand-grip strength (kg)	Hand-grip strength measured using a dynamometer. Higher values indicate greater muscle strength.	Baseline and 12 months
Number of falls	Total number of falls recorded using a falls diary.	12 months
Change from baseline in cortisol levels	Cortisol concentration measured from hair samples (pg/mg). Lower levels indicate better outcome.	Baseline and 12 months
Change from baseline in systolic blood pressure, mmHg.	Lower systolic blood pressure indicates a better outcome.	Baseline and 12 months
Change from baseline in diastolic blood pressure, mmHg.	Lower diastolic blood pressure indicates a better outcome.	Baseline and 12 months
Change from baseline in Body Mass Index (BMI), kg/m2.	Lower BMI value indicates a better outcome.	Baseline and 12 months
Change from baseline in waist circumference, cm.	Lower value indicates a better outcome.	Baseline and 12 months
Change from baseline in blood lipids - Total Cholesterol, mmol/L.	Measured from serum with lower cholesterol value indicating a better outcome.	Baseline and 12 months
Change from baseline in blood lipids - HDL Cholesterol, mmol/L.	Measured from serum with higher HDL cholesterol value indicating a better outcome.	Baseline and 12 months
Change from baseline in blood lipids - LDL Cholesterol, mmol/L.	Measured from serum with lower cholesterol value indicating a better outcome.	Baseline and 12 months
Change from baseline in blood triglycerides, mmol/L.	Measured from serum with lower triglycerides value indicating a better outcome.	Baseline and 12 months
Change from baseline in glycated haemoglobin (HbA1c), %	Measured from fasting blood sample, with lower HbA1c value indicating a better outcome.	Baseline and 12 months
Complete blood count (CBC)	Complete blood count measured from blood samples, including hemoglobin, leukocyte count, and platelet count.	Baseline and 12 months
Change from baseline in S-hsCRP (mg/l)	Measured from serum with lower values indicating a better outcome.	Baseline and 12 months
Change from baseline in physical functioning - Activities-specific Balance Confidence (ABC) Scale	Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.	Baseline and 12 months
Change from baseline in physical functioning - Timed Up and Go (TUG)	Time required to complete the Timed Up and Go test. Lower values indicate better mobility.	Baseline and 12 months
Change from baseline in physical functioning - Frailty (Fried's phenotype)	Frailty score based on five criteria (range 0-5). Lower scores indicate less frailty.	Baseline and 12 months
Change from baseline in quality of life - Care-related Quality of Life instrument (CarerQol)	The answers from Care-related Quality of Life instrument (CarerQol) are transformed into a single index score ranging from 0 (worst possible care situation) to 100 (best possible care situation). Higher scores indicate better care-related quality of life. Primary comparison at 12-months with extended 6-month follow-up.	Baseline, 12 months and 18 months
Change from baseline in social well-being - Experiences of Social Inclusion Scale	The score ranges from 10 to 50, yielding a raw sum score, which is then converted to a scale of 0 to 100, with higher scores indicating greater social inclusion. Primary comparison at 12-months with extended 6-month follow-up.	Baseline, 12 months and 18 months
Change from baseline in health-related quality of life - RAND-36 Health Survey	The scale values are ranging 0-100, with higher scores indicating a better outcome.	Baseline and 12 months
Change from baseline in stress-related symptoms	Perceived Stress Scale (PSS-10). Values ranging 0-40, with lower scores indicating a better outcome.	Baseline and 12 months
Change from baseline in depressive symptoms	Center for Epidemiological Studies Depression scale. Values ranging 0-60, with lower scores indicating a better outcome.	Baseline and 12 months
Change from baseline in depressive symptoms	Geriatric Depression Scale (GDS). Values ranging 0-15, with lower scores indicating a better outcome.	Baseline and 12 months
Change from baseline in nutrition - Mini-Nutritional Assessment (MNA)	Mini Nutritional Assessment (0-14). Higher scores indicate better nutritional status.	Baseline and 12 months
Change from baseline in nutrition - Global Leadership Initiative on Malnutrition (GLIM) criteria	Categorical classification (no malnutrition / moderate / severe).	Baseline and 12 months
Comorbidity (Functional Comorbidity Index score)	List of diseases. Measured as counts. A lower number of diseases indicates a better outcome.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Tarja Välimäki
• Collaborators: Karolinska Institutet; University of California, Davis; Tampere University; Finnish Institute for Health and Welfare; Carers Finland; Alzheimer Society of Finland

Study record dates

Study Major Dates

• Study Start (Estimated): May 28, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: older adults; lifestyle intervention; caregiver; positive mental health; family care
• Other Study ID Numbers: 6/13.00/2026; 362628 (Other Identifier: Research Council of Finland); 362706 (Other Identifier: Research Council of Finland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Family FINGER Trial Steering Group is open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. The Family FINGER Trial Steering Group will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing Family FINGER analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the Family FINGER Trial Steering Group. Access is subject to the applicable legal framework. An access agreement will be prepared and signed by both parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No