Positive Mental HealthNCT07627386
Family FINGER: Lifestyle Intervention Among Older Caregivers
A study testing a multidomain lifestyle intervention in people with Positive Mental Health, run by Tarja Välimäki at 1 site in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positive Mental Health
- What is being tested?
- a multidomain lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 22 Jun 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Department of Nursing Science
Kuopio, 70210
Tarja Välimäki, PhD, +358 40 355 2267, tarja.valimaki@uef.fi
Tarja Välimäki, PhD
About this study
Official title: 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.
Read more
Specific research questions are as follows:
- What is the efficacy of the Family FINGER intervention on mental health?
- What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?
Read the 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.
- Conditions
- Positive Mental Health
- Being tested
- a multidomain lifestyle intervention
- Keywords
- family care, caregiver, lifestyle intervention, positive mental health, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a multidomain lifestyle interventionBehavioural
Also called Family FINGER
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyle Intervention | Experimental | Not described Receives: Behavioral: a multidomain lifestyle intervention |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, parallel-group, single-centre pilot trial testing the effect of the multidomain Family FINGER intervention on positive mental health versus standard care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarja Välimäki
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Karolinska Institutet, University of California, Davis, Finnish Institute for Health and Welfare, Carers Finland, Alzheimer Society of Finland
- Responsible party
- Sponsor-investigator, Tarja Välimäki, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627386
- Sponsor's protocol ID
- 6/13.00/2026
- Other IDs
- 362628, 362706
- Status last verified
- Jul 2026
- First submitted
- 15 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family FINGER: a Pilot Randomised Controlled Trial of Healthy Lifestyle Intervention Versus Standard Care Among Older Caregivers
- ClinicalTrials.gov ID
- NCT07627386
- Acronym / sponsor ID
- 6/13.00/2026
- Conditions
- Positive Mental Health
- Keywords
- family care, caregiver, lifestyle intervention, positive mental health, older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tarja VälimäkiUniversity, hospital or other
- Collaborators
- Tampere University, Karolinska Institutet, University of California, Davis, Finnish Institute for Health and Welfare, Carers Finland, Alzheimer Society of Finland
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the efficacy of the Family FINGER intervention on mental health?
- What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, controlled, parallel-group, single-centre pilot trial testing the effect of the multidomain Family FINGER intervention on positive mental health versus standard care.
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle Intervention | Experimental | Behavioral: a multidomain lifestyle intervention |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a multidomain lifestyle interventionAlso: Family FINGERThe 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. | Behavioural | Healthy Lifestyle Intervention |
Primary outcome
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
7 secondary outcomes
Change from baseline in healthy lifestyle
Time frame: Baseline, 12 months and 18 months
Change from baseline in dementia risk (LIBRA score)
Time frame: Baseline and 12 months
Change from baseline in dementia risk (CAIDE score)
Time frame: Baseline and 12 months
Change from baseline in cognitive function (MoCA score)
Time frame: Baseline and 12 months
Change from baseline in dietary intake
Time frame: Baseline and 12 months
Change from baseline in physical activity frequency (sessions/week)
Time frame: Baseline and 12 months
Change from baseline in physical activity
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a multidomain lifestyle intervention in people with Positive Mental Health, run by Tarja Välimäki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarja Välimäki, PhD (+358 40 355 2267, tarja.valimaki@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) (time frame: Baseline, 6 months, 12 months, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.