DementiaTOMATONCT05866094
nuTritiOn and deMentia AT hOme (TOMATO)
A study testing Nutritional Intervention in people with Dementia and Undernutrition, run by Bournemouth University at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Undernutrition
- What is being tested?
- Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 12 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Participating Home Care Organisation
Greater London
Participating Home Care Organisation
North West Regions
Participating Home Care Organisations
South West
Participating Home Care Organisation
West Midlands
Participating Home Care Organisation
Yorkshire
About this study
Official title: Feasibility Study of an Intervention to Provide Nutritional Care for People Living With Dementia at Home
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.
Read the detailed description
In the United Kingdom, two-thirds of people with dementia live at home and rely on family and friends to support with eating and drinking. Making sure people eat and drink well when they have dementia can be difficult as dementia progresses. Many with dementia are therefore at risk of being undernourished. This can be caused by poor appetite as well as eating and swallowing problems. Being undernourished can lead to poorer health and quality of life for people with dementia (and their carers), increased hospital admissions and health care use costing around £23.5 billion in terms of health and social care expenditure.
Home care workers provide care for people with dementia more frequently and for longer than healthcare professionals. Existing research and our engagement work indicate home care workers are well positioned to assess nutritional status and intervene early, but currently lack training, access to resources and support from NHS services. A more pro-active and wide-ranging approach to nutritional assessment and management is needed targeting interventions at home care workers and family carer dyads, with input from appropriate healthcare professionals.
As a collaborative project, the TOMATO study aims to work together with home care workers, people with dementia, and family carers to adapt a nutrition intervention (initially developed for care home) to support people living with dementia at home with eating and drinking. The intervention includes training programme, toolkit with video, workbook and guides for staff and family carers, and resources and leaflets.
This study will take place in Dorset, Midlands and West Yorkshire in two phases.
Phase 1: The first phase involves adapting the existing nutrition intervention by getting feedback from people with dementia, family carers, home care staff and nutrition experts through semi-structured interviews.
Phase 2: The second phase involves training home care workers to deliver the adapted approach to people with dementia and family carers (up to 32 participant dyads) in receipt of care at home. Information about food intake, weight, practicality, and costs of the approach will be gathered. Semi-structured interviews will also be conducted with participants living with dementia, their family carers, and home care managers to get their feedback on the approach.
If feasible and acceptable (based on progression criteria), findings will inform the design of future trial (effectiveness/implementation research).
The TOMATO patient and public involvement group which consist of family carers, people with dementia and home care workers will provide input throughout the study duration (including project design, delivery, analysis, reporting and dissemination of the findings).
- Conditions
- Dementia, Undernutrition
- Being tested
- Nutritional Intervention
- Keywords
- Dementia, Alzheimer's disease, Malnutrition, Undernutrition, Nutritional Care, Food, Eating, Drinking, Community, Home Care, Older adults, Ageing
- Medical subject headings
- Dementia, Malnutrition, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Intervention | Experimental | Intervention Feasibility Testing (11-months, Phase 2) Receives: Behavioral: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Phase 1 - 4 Months
Intervention Feasibility and Acceptability Testing
- Recruitment: Percentage of participants recruited from participating home care provider.
- Attrition rate: Percentage of participants who drop out of the study before completion.
- 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.
Measured: Phase 2 - 11 Months
Secondary outcomes (5)
Nutritional status
Preliminary assessment at baseline and 4 months follow up:
- Nutritional status
- Body Mass Index (BMI): Body weight (kg) and height (m2) will be combined to determine BMI (weight (kg) / height (m2)).
BMI of < 20 kg/m2 will be an indicator of undernutrition.
Measured: Phase 2 - 11 Months
Health-related quality of life
Preliminary assessment at baseline and 4 months follow up:
- Health-related quality of life for people with dementia and carers will be measured using
- EuroQol 5-Dimension 5-Level (EQ-5D-5L) with a scale from 0 to 100; higher scores indicate better quality of life.
- Dementia Quality of Life questionnaire (DEMQoL) and DEMQoL-Proxy; 4-point scale, higher scores indicate better quality of life.
Measured: Phase 2 - 11 Months
Functional status
Preliminary assessment at baseline and 4 months follow up:
- Functional status
- Functional status (Deterioration in Daily Living Activities in Dementia) using Modified Barthel Index measures; 2-point scale rating with 0 to 20 points. Higher score indicates greater independence.
- Functioning status using Lawton-Brody Instrumental Activities of Daily Living Scale; 4-point scale. Higher scores indicate greater independence and better functional ability.
Measured: Phase 2 - 11 Months
Carer burden
- Carer burden using Zarit Burden Interview; 0 to 88 points; higher scores indicate severe burden.
Measured: Phase 2 - 11 Months
Process Evaluation
Process Evaluation at 4 months: a process evaluation to gather data on intervention fidelity and implementation.
- Semi-structured interviews conducted individually, in pairs or small groups with participant dyads (family carers will be given the option to have a separate interview), home care workers and managers from the participating regions.
- Associated costs variables to deliver the intervention.
Measured: 11 Months [Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start12 Apr 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants: People with dementia, their relatives, and home care workers
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Leeds Beckett University, University of Leeds, University of Exeter, Homecare Association, Leeds Comunity Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Jane Murphy, PhD, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866094
- Sponsor's protocol ID
- 2223/TOMATO/ IRAS1
- Acronym
- TOMATO
- Status last verified
- Sep 2025
- First submitted
- 24 Apr 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32783432Murphy 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.
PubMed 31637756Murphy 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.
PubMed 28196475Yinusa 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.
PubMed 41272684
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Intervention to Provide Nutritional Care for People Living With Dementia at Home
- ClinicalTrials.gov ID
- NCT05866094
- Acronym / sponsor ID
- TOMATO / 2223/TOMATO/ IRAS1
- Conditions
- Dementia, Undernutrition
- Keywords
- Dementia, Alzheimer's disease, Malnutrition, Undernutrition, Nutritional Care, Food, Eating, Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Leeds Beckett University, University of Leeds, University of Exeter, Homecare Association, Leeds Comunity Healthcare NHS Trust
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the United Kingdom, two-thirds of people with dementia live at home and rely on family and friends to support with eating and drinking. Making sure people eat and drink well when they have dementia can be difficult as dementia progresses. Many with dementia are therefore at risk of being undernourished. This can be caused by poor appetite as well as eating and swallowing problems. Being undernourished can lead to poorer health and quality of life for people with dementia (and their carers), increased hospital admissions and health care use costing around £23.5 billion in terms of health and social care expenditure.
Home care workers provide care for people with dementia more frequently and for longer than healthcare professionals. Existing research and our engagement work indicate home care workers are well positioned to assess nutritional status and intervene early, but currently lack training, access to resources and support from NHS services. A more pro-active and wide-ranging approach to nutritional assessment and management is needed targeting interventions at home care workers and family carer dyads, with input from appropriate healthcare professionals.
As a collaborative project, the TOMATO study aims to work together with home care workers, people with dementia, and family carers to adapt a nutrition intervention (initially developed for care home) to support people living with dementia at home with eating and drinking. The intervention includes training programme, toolkit with video, workbook and guides for staff and family carers, and resources and leaflets.
This study will take place in Dorset, Midlands and West Yorkshire in two phases.
Phase 1: The first phase involves adapting the existing nutrition intervention by getting feedback from people with dementia, family carers, home care staff and nutrition experts through semi-structured interviews.
Phase 2: The second phase involves training home care workers to deliver the adapted approach to people with dementia and family carers (up to 32 participant dyads) in receipt of care at home. Information about food intake, weight, practicality, and costs of the approach will be gathered. Semi-structured interviews will also be conducted with participants living with dementia, their family carers, and home care managers to get their feedback on the approach.
If feasible and acceptable (based on progression criteria), findings will inform the design of future trial (effectiveness/implementation research).
The TOMATO patient and public involvement group which consist of family carers, people with dementia and home care workers will provide input throughout the study duration (including project design, delivery, analysis, reporting and dissemination of the findings).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants: People with dementia, their relatives, and home care workers
| Arm | Type | Receives |
|---|---|---|
| Nutrition Intervention | Experimental | Behavioral: Nutritional InterventionIntervention Feasibility Testing (11-months, Phase 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- be able to communicate fluently enough in English or provide informed consent with the assistance of a translator or family member to participate.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional InterventionNutrition 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). | Behavioural | Nutrition Intervention |
Primary outcome
Nutrition Intervention Refinement
Time frame: Phase 1 - 4 Months
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.
Intervention Feasibility and Acceptability Testing
Time frame: Phase 2 - 11 Months
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.
5 secondary outcomes
Nutritional status
Time frame: Phase 2 - 11 Months
Health-related quality of life
Time frame: Phase 2 - 11 Months
Functional status
Time frame: Phase 2 - 11 Months
Carer burden
Time frame: Phase 2 - 11 Months
Process Evaluation
Time frame: 11 Months [Phase 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 32783432Murphy 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.
- Background: PubMed 31637756Murphy 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.
- Background: PubMed 28196475Murphy 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.
- Derived from this study: PubMed 41272684Yinusa 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.
- Project TOMATO WebPageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Murphy, PhD principal investigator
Bournemouth University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with Dementia and Undernutrition, run by Bournemouth University at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition Intervention Refinement (time frame: Phase 1 - 4 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866094, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.