Strength for Caregiving

NCT07615205 | Not Yet Recruiting DMC

• 1 other identifier: SatakuntaUAS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 10 months

Secondary Outcomes (5)

• Psychological burden measured with the Zarit Burden Interview, 4-item version (ZBI-4)

  Baseline and 10 months

• Physical functioning measured with the five-times sit-to-stand test and hand grip strength measured with a grip dynamometer

  Baseline and 10 months

• Protein intake measured with a 3-day food diary

  Baseline and 10 months.

• Nutritional status measured with the Mini Nutritional Assessment, long form (MNA)

  Baseline and 10 months

• Quality of life measured with the 15D instrument

  Baseline and 10 months

Study Arms (1)

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.

Behavioral: Tailored nutritional counselling intervention

Interventions

Tailored nutritional counselling intervention BEHAVIORAL

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.

Tailored nutritional counselling intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Susanna Kunvik: lead
• City of Rauma: collaborator
• City of Kankaapää: collaborator
• Satakunta Wellbeing Services County: collaborator
• Adult education centre of Pori: collaborator
• Adult education centre of Rauma: collaborator
• Petäjä Adult Education Centre: collaborator
• City of Pori: collaborator
• Satakunta Caregivers Association: collaborator
• The Martha association of South West Finland: collaborator

Study Sites (1)

Satakunta University of Applied Sciences

Pori, Satakunta, 28130, Finland

Location

Related Links

• the study's website, open in June 2026

MeSH Terms

Conditions

Psychological Well-Being; Feeding Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavior, Animal

Study Officials

• Susanna Kunvik

  Satakunta University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Kunvik, PhD

CONTACT

+358447103204; susanna.kunvik@samk.fi

Petra Rautakallio-Järvinen, MSc

CONTACT

+358 50 359 7196; petra.rautakallio-jarvinen@samk.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal researcher

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

FI (1)