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Strength for Caregiving

2026년 5월 22일 업데이트: Susanna Kunvik

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.

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Satakunta
      • Pori, Satakunta, 핀란드, 28130
        • Satakunta University of Applied Sciences
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Juha Puustinen, Doctor of Medicine
        • 부수사관:
          • Petra Rautakallio-Järvinen, MsC

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

설명

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Tailored nutritional counselling intervention
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mental well-being measured with the World Health Organization-Five Well-Being Index (WHO-5)
기간: 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.
Baseline and 10 months

2차 결과 측정

결과 측정
측정값 설명
기간
Psychological burden measured with the Zarit Burden Interview, 4-item version (ZBI-4)
기간: Baseline and 10 months
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.
Baseline and 10 months
Physical functioning measured with the five-times sit-to-stand test and hand grip strength measured with a grip dynamometer
기간: Baseline and 10 months
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.
Baseline and 10 months
Protein intake measured with a 3-day food diary
기간: Baseline and 10 months.
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.
Baseline and 10 months.
Nutritional status measured with the Mini Nutritional Assessment, long form (MNA)
기간: Baseline and 10 months
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. Participants will be classified as having normal nutritional status, being at risk of malnutrition, or being malnourished.
Baseline and 10 months
Quality of life measured with the 15D instrument
기간: Baseline and 10 months
Quality of life will be assessed using the 15D instrument. 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.
Baseline and 10 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 11월 1일

연구 완료 (추정된)

2027년 11월 1일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 5월 22일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 22일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

삶의 질에 대한 임상 시험

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