Strength for Caregiving

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSusanna Kunvik

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Tailored nutritional counselling interventionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 10 months

Secondary outcomes

1

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.

Time frame
Baseline and 10 months
2

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.

Time frame
Baseline and 10 months
3

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.

Time frame
Baseline and 10 months.
4

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.

Time frame
Baseline and 10 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Susanna Kunvik

Lead sponsor

Satakunta University of Applied Sciences

Sponsor institution

City of Pori

Collaborator

City of Rauma

Collaborator

The Martha association of South West Finland

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

Satakunta Caregivers Association

Collaborator

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