nuTritiOn and deMentia AT hOme (TOMATO)

NCT05866094 | Completed

• 1 other identifier: 2223/TOMATO/ IRAS1
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to refine, implement and assess the acceptability and feasibility of an existing nutrition intervention applied to people living with dementia receiving home care.

Conditions

Dementia; Undernutrition

Keywords

Dementia; Alzheimer's disease; Malnutrition; Undernutrition; Nutritional Care; Food; Eating; Drinking; Community; Home Care; Older adults; Ageing

Outcome Measures

Primary Outcomes (2)

• Nutrition Intervention Refinement

  Exploring the perspective of participants in phase 1 via semi-structured in-depth interviews (people with dementia, their family carers, and home care staff). • Qualitative analysis will be carried out to understand more about how nutritional care is currently provided for people with dementia at home and how our existing nutrition intervention can be adapted for home care.

  Phase 1 - 4 Months

• Intervention Feasibility and Acceptability Testing

  1. Recruitment: Percentage of participants recruited from participating home care provider. 2. Attrition rate: Percentage of participants who drop out of the study before completion. 3. Qualitative analysis of the feasibility and acceptability of the adapted intervention from the perspective of people with dementia, their family carers, and home care staff and healthcare professionals.

  Phase 2 - 11 Months

Secondary Outcomes (5)

• Nutritional status

  Phase 2 - 11 Months

• Health-related quality of life

  Phase 2 - 11 Months

• Functional status

  Phase 2 - 11 Months

• Carer burden

  Phase 2 - 11 Months

• Process Evaluation

  11 Months [Phase 2

Study Arms (1)

Nutrition Intervention

EXPERIMENTAL

Intervention Feasibility Testing (11-months, Phase 2)

Behavioral: Nutritional Intervention

Interventions

Nutritional Intervention BEHAVIORAL

Nutrition training will be provided to home care staff to deliver the intervention via the participating Home Care Providers from two localities (South and North of England). This phase will involve identification of people with dementia on their caseload, preliminary assessment of potential impact via collection of quantitative data at baseline (pre-intervention), and at 4 months follow-up (4 months after the first visit by trained home care workers, following baseline). A process evaluation will be conducted to gather data on intervention fidelity and implementation (quantitative and qualitative).

Nutrition Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with Dementia
• formal diagnosis or functional symptoms associated with probable dementia (assessed by a senior home care worker using the FAST).
• have family member/friend providing care/support and resident in the same house as the person with dementia or living close by.
• be currently or have recently (in last 6-months) been at risk of/experienced malnutrition in receipt of home care services.
• \- For interviews, people with dementia will
• be able to communicate fluently enough in English or provide informed consent with the assistance of a translator or family member to participate.
• be able to recall their experiences of malnutrition and carer/home care worker responses well enough to discuss.
• Carers and Home Care Workers
• currently or have recently (in last 6-months) provided care for someone with dementia at risk of/experiencing malnutrition.
• able to communicate fluently enough in English or provide informed consent with the assistance of a translator or family member to participate.

You may not qualify if:

• People with Dementia
• Who are at end of life or on an end-of-life care pathway.
• Permanently cared for in bed.
• Do not have an informal caregiver.
• having specialist nutritional support e.g., feeding via tube.
• Carers and Home Care Workers
• have not recently (in last 6-months) provided care for someone with dementia at risk of/experiencing malnutrition.
• not able to communicate fluently enough in English or provide informed consent

Sponsors & Collaborators

• Bournemouth University: lead
• Leeds Beckett University: collaborator
• University of Leeds: collaborator
• University of Exeter: collaborator
• Homecare Association: collaborator
• Leeds Comunity Healthcare NHS Trust: collaborator

Study Sites (5)

Participating Home Care Organisation

Greater London, United Kingdom

Location

Participating Home Care Organisation

North West Regions, United Kingdom

Location

Participating Home Care Organisations

South West, United Kingdom

Location

Participating Home Care Organisation

West Midlands, United Kingdom

Location

Participating Home Care Organisation

Yorkshire, United Kingdom

Location

Related Publications (4)

• Murphy J, Aryal N. Improving the provision of nutritional care for people living with dementia in care homes. Nurs Older People. 2020 Sep 22;32(5):23-29. doi: 10.7748/nop.2020.e1263. Epub 2020 Aug 12.

  PMID: 32783432 BACKGROUND

• Murphy JL, Aburrow A, Guestini A, Brown R, Parsons E, Wallis K. Identifying older people at risk of malnutrition and treatment in the community: prevalence and concurrent validation of the Patients Association Nutrition Checklist with 'MUST'. J Hum Nutr Diet. 2020 Feb;33(1):31-37. doi: 10.1111/jhn.12710. Epub 2019 Oct 22.

  PMID: 31637756 BACKGROUND

• Murphy JL, Holmes J, Brooks C. Nutrition and dementia care: developing an evidence-based model for nutritional care in nursing homes. BMC Geriatr. 2017 Feb 14;17(1):55. doi: 10.1186/s12877-017-0443-2.

  PMID: 28196475 BACKGROUND

• Yinusa G, Surr C, Thomas S, Fenge LA, Howdon D, Major J, Heward M, Taylor G, Knight H, Townson J, Murphy J. An intervention to provide nutritional care for people living with dementia at home receiving home care (TOMATO): study protocol for a single-arm feasibility study. Pilot Feasibility Stud. 2025 Nov 21;11(1):146. doi: 10.1186/s40814-025-01722-5.

  PMID: 41272684 DERIVED

Related Links

• Project TOMATO WebPage

MeSH Terms

Conditions

Dementia; Malnutrition; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Jane Murphy, PhD

  Bournemouth University

  PRINCIPAL INVESTIGATOR

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

Model Details: Participants: People with dementia, their relatives, and home care workers

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 19, 2023
• Study Start: April 12, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

GB (5)