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Strength for Caregiving

2026年5月22日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • フィンランド
    • Satakunta
      • Pori、Satakunta、フィンランド、28130
        • Satakunta University of Applied Sciences
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Juha Puustinen, Doctor of Medicine
        • 副調査官：
          • Petra Rautakallio-Järvinen, MsC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

はい

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：Tailored nutritional counselling intervention
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mental well-being measured with the World Health Organization-Five Well-Being Index (WHO-5)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Psychological burden measured with the Zarit Burden Interview, 4-item version (ZBI-4)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Susanna Kunvik

協力者

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

捜査官

  • 主任研究者：Susanna Kunvik、Satakunta University of Applied Sciences

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月22日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SatakuntaUAS

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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