Mental Well-beingNCT07615205
Strength for Caregiving
A study testing Tailored nutritional counselling intervention in people with Mental Well-being and Muscle Strengh, run by Susanna Kunvik at 1 site in Finland.
Trial summary
The goal of this single-arm pre-post study is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being and functional capacity through comprehensive nutritional guidance. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Well-being, Muscle Strengh, Dietary Habits
- What is being tested?
- Tailored nutritional counselling 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
- Sep 2026to Nov 2027
- 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
- Born in 1961 or earlier (i.e. aged over 65 years)
- Adequate Finnish language skills
- Able to give informed written consent
- Acting as a caregiver (with or without a formal caregiver contract) in the areas of Pori, Rauma, or Kankaanpää
- Normal cognition (participants with an MMSE score below 24 will be assessed by the responsible physician)
Who cannot join
- Serious acute illness or inability to act as an informal caregiver
- A condition, ailment, or underlying health risk that is poorly controlled and that participation in the study could exacerbate, or a terminal illness (Consultation of the doctor in charge, if necessary, in unclear cases)
- Born in 1961 or later (i.e. aged under 65 years)
- Substance abuse based on the AUDIT-C score (consultation of the doctor in charge)
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
Satakunta University of Applied Sciences
Pori, Satakunta, 28130
Susanna Kunvik, PhD, +358447103204, susanna.kunvik@samk.fi
Elina Nevala, Msc, +358505737358, elina.nevala@samk.fi
About this study
Official title: Strength for Caregiving - A Nutrition Coaching Model to Support Caregivers' Wellbeing and Functional Ability
The goal of this single-arm pre-post study is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being and functional capacity through comprehensive nutritional guidance. The main goals of the project are to:
- Improve the well-being, resilience, and functional capacity of the participating family caregivers through the comprehensive nutritional counseling implemented as part of the project.
- Create a nutrition counseling model that promotes the well-being and coping of family caregivers and can also be utilized in well-being services counties after the project concludes.
- Produce up-to-date and practical nutrition materials for family caregivers.
Read more
The project participants will participate in two individual nutrition counselling sessions and three group nutrition counseling sessions over a period of ten months.
Researchers will compare the results of the participants' baseline and final measurements to see if nutrition counseling is effective in improving family caregivers' well-being, resilience, and functional capacity.
Read the detailed description
Background: A large proportion of Finnish family caregivers are older adults. Serving as a family caregiver places both psychological and physical strain on the caregiver. As a result, taking care of one's own well-being may be overlooked. Previous studies have shown that up to 40% of family caregivers may be at risk of malnutrition. Inadequate nutrition weakens family caregivers' health and functional capacity, potentially threatening their ability to continue providing care. At present, there is no structured and clearly defined approach to systematically addressing the nutritional status and nutritional needs of family caregivers as part of family caregivers services. Consequently, family caregivers may not receive easily accessible, targeted, and reliable nutritional guidance or materials, even though nutrition is an important factor in maintaining health, functional capacity and the ability to continue caregiving.
Aims: The aim of the Strength for Caregiving project is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being, and functional capacity through comprehensive nutritional counseling. In addition, the project aims to develop and pilot a nutritional counseling model targeted at family caregivers. The project will also produce nutrition materials for family caregivers.
Methods: The study examines the effectiveness of a 10-month tailored nutritional counseling intervention on well-being, functional capacity, nutritional status and dietary habits among elderly caregivers living in the Satakunta region, Finland. The planned sample size is 100 participants.
The 10-month intervention includes two individual counseling sessions and three group counseling sessions. The individual sessions are conducted by a nutritionist and include a personal nutrition plan. Based on the participants' preferences, the group sessions consist of either nutrition lectures or practical cooking courses.
Study outcomes are assessed at baseline and after 10 months. Outcomes are measured using questionnaires and three-day food records. Nutritional status, weight, blood pressure and muscle strength are measured at the same time points during appointments with research nurse.
Expected outcomes: The project is expected to improve family caregivers' dietary habits, well-being, and functional capacity. The nutrition coaching model will include individual and group counseling, practical cooking courses, and materials for implementing these activities, enabling different organizations and professionals to use the model and continue providing counseling after the project has ended. The materials produced will be publicly available and widely usable after the project.
Discussion: The study will support family caregivers' ability to continue their caregiving role and help reduce nutrition-related health risks. Integrating the nutrition counseling model into family caregiver services in the well-being services county will lay the foundation for long-term change. Openly available materials may help ensure that the project's impact continues beyond the project period.
- Conditions
- Mental Well-being, Muscle Strengh, Dietary Habits, Quality of Life, Nutritional Status, Functional Capacity
- Being tested
- Tailored nutritional counselling intervention
- Keywords
- Nutrition, Caregiver, mental well-being, Functional capacity, Quality of life, Nutritional counseling, Intervention
- Medical subject headings
- Psychological Well-Being, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored nutritional counselling interventionBehavioural
The intervention is a 10-month tailored nutritional counselling programme for elderly family caregivers. It includes two individual dietary counselling sessions conducted by a nutrition specialist and three group counselling sessions. The individual counselling sessions include a personal nutrition plan based on the participant's needs. According to participants' preferences, the group counselling sessions consist of either nutrition lectures or practical cooking courses. The intervention aims to improve participants' well-being, functional capacity, and dietary habits.
| Study group | Role | What they receive |
|---|---|---|
| Tailored nutritional counselling intervention | Experimental | This is a single-arm pre-post study. Participants in this arm are elderly family caregivers living in the Satakunta region. All participants receive a 10-month tailored nutritional counselling intervention aimed at improving well-being, functional capacity, and dietary habits. The intervention includes two individual dietary counselling sessions conducted by a nutrition specialist and three group counselling sessions. Based on participants' preferences, the group sessions consist of either group-based nutrition lectures or practical cooking courses. The individual counselling includes a personal nutrition plan. Receives: Behavioral: Tailored nutritional counselling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental well-being measured with the World Health Organization-Five Well-Being Index (WHO-5)
Psychological well-being of participating informal caregivers will be assessed using the WHO-5 Well-Being Index. The WHO-5 consists of five positively worded items measuring mood, vitality, positive affect, and general psychological well-being during the previous two weeks. Each item is scored on a 6-point Likert scale from 0 to 5, giving a total raw score range of 0-25. The raw score may be multiplied by 4 to obtain a transformed score from 0 to 100, where higher scores indicate better psychological well-being.
Measured: Baseline and 10 months
Secondary outcomes (5)
Psychological burden measured with the Zarit Burden Interview, 4-item version (ZBI-4)
Psychological burden of participating caregivers will be assessed using the 4-item version of the Zarit Burden Interview. Each item is scored on a 5-point Likert scale from 0 to 4. The total score ranges from 0 to 16, with higher scores indicating greater psychological burden. A score of 8 or higher indicates high caregiver burden.
Measured: Baseline and 10 months
Physical functioning measured with the five-times sit-to-stand test and hand grip strength measured with a grip dynamometer
Physical functioning and lower-limb muscle strength will be assessed using the five-times sit-to-stand test. Participants rise from a chair and sit down five times as quickly as possible, with arms crossed over the chest. The outcome is the time needed to complete the test, measured in seconds. A longer completion time indicates poorer lower-limb muscle strength and physical functioning. Muscle strength will also be assessed using hand grip strength measured with a grip dynamometer. The outcome is grip strength, with higher values indicating better muscle strength.
Measured: Baseline and 10 months
Protein intake measured with a 3-day food diary
Protein intake will be assessed using a 3-day food diary including two weekdays and one weekend day. The outcomes include total daily protein intake and protein intake relative to body weight. Protein intake will be reported as grams per day and grams per kilogram of body weight per day.
Measured: Baseline and 10 months.
Nutritional status measured with the Mini Nutritional Assessment, long form (MNA)
Nutritional status will be assessed using the long form of the Mini Nutritional Assessment. The MNA includes anthropometric measurements, dietary assessment, general health and functioning, and self-perceived health and nutritional status. The maximum score of the long version of the MNA is 30 points. A score of 24-30 points indicates normal nutritional status, 17-23.5 points indicates an increased risk of malnutrition, and a score below 17 points indicates malnutrition.
Measured: Baseline and 10 months
Quality of life measured with the 15D instrument
Quality of life will be assessed using the 15D instrument which is a self-assessment-based quality of life measure developed, validated, and widely used in Finland. The 15D includes 15 dimensions of health and functioning, each scored on five levels. The responses are combined into a single 15D index score ranging from 0 to 1, where 0 represents death and 1 represents full health. Higher scores indicate better health-related quality of life.
Measured: Baseline and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Well-beingStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The 10-month intervention includes two individual and three group counseling sessions. The individual sessions are conducted by a nutrition specialist and include a personal nutrition plan. Based on the participants' preferences, the group sessions consist of either nutrition lectures or practical cooking courses.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susanna Kunvik
- Sponsor type
- University, hospital or other
- Collaborators
- City of Pori, City of Rauma, The Martha association of South West Finland, City of Kankaapää, Satakunta Wellbeing Services County, Adult education centre of Pori, Adult education centre of Rauma, Petäjä Adult Education Centre, Satakunta Caregivers Association
- Responsible party
- Sponsor-investigator, Susanna Kunvik, Satakunta University of Applied Sciences
- Investigators
- Susanna Kunvik, Principal investigator, Satakunta University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615205
- Sponsor's protocol ID
- SatakuntaUAS
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been determined whether individual participant data will be shared. The decision will depend on participant consent, ethics approval, data protection requirements, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength for Caregiving - A Nutrition Coaching Model to Support Caregivers' Wellbeing and Functional Ability
- ClinicalTrials.gov ID
- NCT07615205
- Acronym / sponsor ID
- SatakuntaUAS
- Conditions
- Mental Well-being, Muscle Strengh, Dietary Habits, Quality of Life, Nutritional Status, Functional Capacity
- Keywords
- Nutrition, Caregiver, mental well-being, Functional capacity, Quality of life, Nutritional counseling, Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Susanna KunvikUniversity, hospital or other
- Collaborators
- City of Pori, City of Rauma, The Martha association of South West Finland, City of Kankaapää, Satakunta Wellbeing Services County, Adult education centre of Pori, Adult education centre of Rauma, Petäjä Adult Education Centre, Satakunta Caregivers Association
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 May 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 goal of this single-arm pre-post study is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being and functional capacity through comprehensive nutritional guidance. The main goals of the project are to:
- Improve the well-being, resilience, and functional capacity of the participating family caregivers through the comprehensive nutritional counseling implemented as part of the project.
- Create a nutrition counseling model that promotes the well-being and coping of family caregivers and can also be utilized in well-being services counties after the project concludes.
- Produce up-to-date and practical nutrition materials for family caregivers.
The project participants will participate in two individual nutrition counselling sessions and three group nutrition counseling sessions over a period of ten months.
Researchers will compare the results of the participants' baseline and final measurements to see if nutrition counseling is effective in improving family caregivers' well-being, resilience, and functional capacity.
Detailed description
Background: A large proportion of Finnish family caregivers are older adults. Serving as a family caregiver places both psychological and physical strain on the caregiver. As a result, taking care of one's own well-being may be overlooked. Previous studies have shown that up to 40% of family caregivers may be at risk of malnutrition. Inadequate nutrition weakens family caregivers' health and functional capacity, potentially threatening their ability to continue providing care. At present, there is no structured and clearly defined approach to systematically addressing the nutritional status and nutritional needs of family caregivers as part of family caregivers services. Consequently, family caregivers may not receive easily accessible, targeted, and reliable nutritional guidance or materials, even though nutrition is an important factor in maintaining health, functional capacity and the ability to continue caregiving.
Aims: The aim of the Strength for Caregiving project is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being, and functional capacity through comprehensive nutritional counseling. In addition, the project aims to develop and pilot a nutritional counseling model targeted at family caregivers. The project will also produce nutrition materials for family caregivers.
Methods: The study examines the effectiveness of a 10-month tailored nutritional counseling intervention on well-being, functional capacity, nutritional status and dietary habits among elderly caregivers living in the Satakunta region, Finland. The planned sample size is 100 participants.
The 10-month intervention includes two individual counseling sessions and three group counseling sessions. The individual sessions are conducted by a nutritionist and include a personal nutrition plan. Based on the participants' preferences, the group sessions consist of either nutrition lectures or practical cooking courses.
Study outcomes are assessed at baseline and after 10 months. Outcomes are measured using questionnaires and three-day food records. Nutritional status, weight, blood pressure and muscle strength are measured at the same time points during appointments with research nurse.
Expected outcomes: The project is expected to improve family caregivers' dietary habits, well-being, and functional capacity. The nutrition coaching model will include individual and group counseling, practical cooking courses, and materials for implementing these activities, enabling different organizations and professionals to use the model and continue providing counseling after the project has ended. The materials produced will be publicly available and widely usable after the project.
Discussion: The study will support family caregivers' ability to continue their caregiving role and help reduce nutrition-related health risks. Integrating the nutrition counseling model into family caregiver services in the well-being services county will lay the foundation for long-term change. Openly available materials may help ensure that the project's impact continues beyond the project period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The 10-month intervention includes two individual and three group counseling sessions. The individual sessions are conducted by a nutrition specialist and include a personal nutrition plan. Based on the participants' preferences, the group sessions consist of either nutrition lectures or practical cooking courses.
| Arm | Type | Receives |
|---|---|---|
| Tailored nutritional counselling intervention | Experimental | Behavioral: Tailored nutritional counselling interventionThis is a single-arm pre-post study. Participants in this arm are elderly family caregivers living in the Satakunta region. All participants receive a 10-month tailored nutritional counselling intervention aimed at improving well-being, functional capacity, and dietary habits. The intervention includes two individual dietary counselling sessions conducted by a nutrition specialist and three group counselling sessions. Based on participants' preferences, the group sessions consist of either group-based nutrition lectures or practical cooking courses. The individual counselling includes a personal nutrition plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Born in 1961 or earlier (i.e. aged over 65 years)
- Adequate Finnish language skills
- Able to give informed written consent
- Acting as a caregiver (with or without a formal caregiver contract) in the areas of Pori, Rauma, or Kankaanpää
- Normal cognition (participants with an MMSE score below 24 will be assessed by the responsible physician)
Key exclusion criteria (4 listed)
- Serious acute illness or inability to act as an informal caregiver
- A condition, ailment, or underlying health risk that is poorly controlled and that participation in the study could exacerbate, or a terminal illness (Consultation of the doctor in charge, if necessary, in unclear cases)
- Born in 1961 or later (i.e. aged under 65 years)
- Substance abuse based on the AUDIT-C score (consultation of the doctor in charge)
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 |
|---|---|---|
| Tailored nutritional counselling interventionThe intervention is a 10-month tailored nutritional counselling programme for elderly family caregivers. It includes two individual dietary counselling sessions conducted by a nutrition specialist and three group counselling sessions. The individual counselling sessions include a personal nutrition plan based on the participant's needs. According to participants' preferences, the group counselling sessions consist of either nutrition lectures or practical cooking courses. The intervention aims to improve participants' well-being, functional capacity, and dietary habits. | Behavioural | Tailored nutritional counselling intervention |
Primary outcome
Mental well-being measured with the World Health Organization-Five Well-Being Index (WHO-5)
Time frame: Baseline and 10 months
Psychological well-being of participating informal caregivers will be assessed using the WHO-5 Well-Being Index. The WHO-5 consists of five positively worded items measuring mood, vitality, positive affect, and general psychological well-being during the previous two weeks. Each item is scored on a 6-point Likert scale from 0 to 5, giving a total raw score range of 0-25. The raw score may be multiplied by 4 to obtain a transformed score from 0 to 100, where higher scores indicate better psychological well-being.
5 secondary outcomes
Psychological burden measured with the Zarit Burden Interview, 4-item version (ZBI-4)
Time frame: Baseline and 10 months
Physical functioning measured with the five-times sit-to-stand test and hand grip strength measured with a grip dynamometer
Time frame: Baseline and 10 months
Protein intake measured with a 3-day food diary
Time frame: Baseline and 10 months.
Nutritional status measured with the Mini Nutritional Assessment, long form (MNA)
Time frame: Baseline and 10 months
Quality of life measured with the 15D instrument
Time frame: Baseline and 10 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 Jun 2026.
- the study's website, open in June 2026Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It has not yet been determined whether individual participant data will be shared. The decision will depend on participant consent, ethics approval, data protection requirements, and institutional policies.
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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.
Susanna Kunvik principal investigator
Satakunta University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored nutritional counselling intervention in people with Mental Well-being and Muscle Strengh, run by Susanna Kunvik 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Jun 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 Susanna Kunvik, PhD (+358447103204, susanna.kunvik@samk.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental well-being measured with the World Health Organization-Five Well-Being Index (WHO-5) (time frame: Baseline and 10 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 Jun 2026.