REFRESH study: nutRition intervEntions For malnouRished oldEr adultS in care Homes - A parallel, superiority, three-arm cluster randomised controlled trial
| ISRCTN | ISRCTN15687909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15687909 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 334241 |
| Protocol serial number | CPMS 58561, NIHR160348 |
| Sponsor | University of Plymouth |
| Funder | National Institute for Health and Care Research |
- Submission date
- 04/08/2025
- Registration date
- 16/10/2025
- Last edited
- 09/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Many older people living in care homes are at risk of malnutrition, which means they aren’t getting the nutrients they need. This can lead to poor health, lower quality of life, and a higher chance of falls and infections. The REFRESH study will compare three approaches to nutritional care: fortified foods, supplement drinks, and usual care. Around 1,530 residents from 90 care homes will take part to help find out which approach works best to improve nutrition and quality of life.
Who can participate?
Participants will be older adults (65 years or over) with or at risk of malnutrition, living in a care home which has applied to take part and met certain care home inclusion criteria.
What does the study involve?
Once eligible care home residents (or consultees) have agreed to take part in the study, initial information will be collected (baseline data). Each care home will then be randomly placed into one of three groups. Residents will receive one of the following for 12 months:
• Oral nutritional supplements: Two ready-to-drink supplements each day between meals, alongside their usual diet.
• Fortified food: Meals, snacks and drinks made with extra protein, calories, vitamins and minerals, alongside their usual diet.
• Usual care: The care home will continue with their usual approach to nutrition for residents who are malnourished.
Further information will be collected at 6 months and again at 12 months.
What are the possible benefits and risks of participating?
We cannot guarantee there will be any benefits from taking part in the study as we do not know what the results will be. However, the participants’ involvement will contribute to the development of new knowledge and understanding of malnutrition in care homes, which could help to improve the care of older people in the future.
There is a chance that the oral nutritional supplements or the fortified food may cause the following:
- Gastrointestinal symptoms (i.e., constipation, bloating, nausea)
- Poorly controlled blood glucose (blood sugar levels that are too high or too low) in those with diabetes.
These effects may occur whichever group the participant is in, including usual care if these options are used as part of it. If necessary, the food or supplement which is thought to be the cause would be stopped.
Where is the study run from?
University of Plymouth (UK)
When is the study starting and how long is it expected to run for?
January 2025 to December 2028
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
refresh.penctu@plymouth.ac.uk
Contact information
Principal investigator
University of Plymouth
School of Health Professions
Intercity Place
North Road East
Plymouth
PL4 6AB
United Kingdom
 ORCID ID |
0000-0001-7996-0095 |
|---|---|
| mary.hickson@plymouth.ac.uk |
Principal investigator
The Adam Practice
Upton Surgery
Blandford Road North
Poole
BH16 5PW
United Kingdom
| ORCID ID |
0000-0003-3531-5566 |
|---|---|
| jane.murphy@dorsetgp.nhs.uk |
Public, Scientific
University of Plymouth
Plymouth
PL4 8AA
United Kingdom
| refresh.penctu@plymouth.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Scientific title | NutRition intervEntions For malnouRished oldEr adultS in care Homes (REFRESH) |
| Study acronym | REFRESH |
| Study objectives | Research question: In older adults with or at risk of malnutrition living in care homes, what is the clinical and cost-effectiveness of oral nutritional supplements (ONS arm) and fortified food (FF arm) compared to routine practice (usual care arm)? Primary objective: The primary objective is to compare the health-related quality of life of care home residents (with or at risk of malnutrition) receiving the ONS and FF with those receiving usual care, measured using EQ-5D-5L-proxy, at 6 months’ follow-up. Secondary objectives: 1. Evaluate the effects of ONS and FF compared to usual care on: 1.1. Dementia-specific Quality of Life (DEMQoL-CH) at 6 months post-randomisation 1.2. Nutritional status (Mini Nutritional Assessment (MNA)) at 6 months post-randomisation 1.3. Weight (kg) at 6 months post-randomisation 1.4. Dietary intake (3-day photographed food records and food record charts used to estimate nutrient content) at 6 months post-randomisation 1.5. Functional limitations (Modified Barthel Index (MBI)) at 6 months post-randomisation 1.6. Acceptability and adherence (3-day photographed food records and food record charts at 6 months post-randomisation) 1.7. Morbidity (antibiotic usage) at 6 months post-randomisation 1.8. Mortality (registered death records) at 6 months and 12 months post-randomisation 1.9. EQ-5D-5L-proxy at 12 months post randomisation 2. Evaluate the cost-effectiveness of ONS and FF compared to usual care at 6- and 12-months post randomisation by measuring the cost of delivering the ONS and FF interventions, participant health and social care resource use (bespoke health and care service use questionnaire) and health-related quality of life (EQ-5D-5L utility values). |
| Ethics approval(s) |
Approved 07/10/2025, West Midlands – Coventry & Warwickshire Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8151; Coventryandwarwick.rec@hra.nhs.uk), ref: 25/WM/0154 |
| Health condition(s) or problem(s) studied | Malnutrition |
| Intervention | Each participating care home will be randomised into one of the following trial arms: Oral Nutritional Supplement (ONS) Arm: Residents would receive two ready-to-drink ONS to be given at suitable points within the day between mealtimes, daily for 12 months. Residents will continue to receive meals and nutritional care according to the care home’s usual routines. Fortified Food (FF) Arm: Care homes would instigate a menu providing fortified food (usual food, drinks and snacks with added ingredients to increase nutrient density for participating residents) for 12 months. The fortified menu will be very similar in content to the usual menu, but some items will be fortified (e.g. porridge, mashed potato, soups etc.). We will provide a list of nutrient dense ingredients that can be used to fortify different items on the menu (e.g. milk powder, peanut butter, cheese, eggs etc.). Residents will continue to receive nutritional care according to the care home’s usual routines. Care homes randomised to one of the above intervention arms will receive manualised training split into two levels: malnutrition awareness training and management of malnutrition training tailored to the allocated intervention. These care homes will be asked to appoint an ‘in-house’ nutrition champion to help disseminate information, promote, and embed the training during the trial, and support data collection. Usual Care Arm: These care homes should manage malnutrition as they usually would. Following recruitment of the trial participants and completion of the baseline assessments, care homes (clusters) will be randomly allocated in a 1:1:1 ratio to one of the three trial arms (30 care homes per trial arm) using block randomisation via computer generated random numbers. Care homes will be sequentially randomised (i.e., individually as soon as they are ready for allocation) following collection of the baseline data, rather than being randomised in batches (i.e., at the same time as other care homes). |
| Intervention type | Other |
| Primary outcome measure(s) |
Health-related quality of life (HRQoL) measured using EQ-5D-5L Proxy Version 2 at 6 months |
| Key secondary outcome measure(s) |
1. Dementia-specific quality of life measured using (DEMQoL-CH) at 6 months post-randomisation |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 1530 |
| Key inclusion criteria | 1. Permanent resident in a care home (not respite or intermediate care) 2. Aged ≥65 years at the time of consent 3. Able to eat and drink 4. With or at risk of malnutrition as measured by scoring 1 or more out of 6 on the MUST 5. Able to obtain informed consent from the individual or a consultee based on the presumed will of an incapacitated adult |
| Key exclusion criteria | 1. Fed via feeding tube 2. Already receiving nutrition support (ONS or fortified meals) on the advice of a healthcare professional (e.g. GP) and/or individualised dietetic advice 3. Active cancer treatment or recent major surgery 4. Considered by the care home staff to be approaching the end of life, where participation in the study would not be appropriate‡. ‡In cases where there is uncertainty, this decision will be made collaboratively by care home staff, in consultation with the resident (where possible), and a consultee (if applicable). Care home staff, who are leading initial discussions about the study, will use their professional judgment on a case-by-case basis to ensure that the decision reflects the resident’s condition, preferences, and advice of the consultee (if applicable). |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 31/05/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Brixham
TQ5 0DT
England
Yeovil
BA20 2RG
England
Paignton
TQ3 3JW
England
Wellington
TA21 9HY
England
Exmouth
EX8 2BT
England
Newton Abbot
TQ13 9JS
England
Paignton
TQ3 2DY
England
Leominster
HR6 0QJ
England
Wyre Hill
Bewdley
DY12 2QQ
England
Newport
TF10 7EQ
England
Kempsey
Worcester
WR5 3NF
England
Compton
Wolverhampton
WV3 9JJ
England
Christchurch
BH23 2GZ
England
Weymouth
DT4 7LF
England
Broadstone
BH18 8AL
England
Poole
BH15 4HY
England
Talbot Woods
Bournemouth
BH3 7AZ
England
Westbury-on-trym
Bristol
BS10 7QD
England
Bristol
BS9 1JF
England
Chippenham
SN15 5BH
England
Corston
Bath
BA2 9AE
England
Galmpton
Brixham
TQ5 0LW
England
Launceston
PL15 9HF
England
Cradley Heath
B64 7LT
England
Colyford
Colyton
EX24 6QJ
England
Stoke
Plymouth
PL1 4QJ
England
Looe
PL13 1NN
England
Larkhall
Bath
BA1 6TL
England
Birmingham
B23 5XN
England
Kings Heath
Birmingham
B13 0PN
England
Newton Abbot
TQ12 1RJ
England
Bristol
BS4 5HU
England
Brindley Ford
Stoke-on-trent
ST8 7QL
England
Bournemouth
BH4 9LA
England
Paignton
TQ4 5AW
England
Selly Park
Birmingham
B29 7PP
England
Exmouth
EX8 2SD
England
Penn
Wolverhampton
WV4 4DH
England
Wimborne
BH21 1AS
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository: Ater the trial has been reported, an anonymised dataset may be committed to University of Plymouth’s open access research repository: https://pearl.plymouth.ac.uk/ The datasets generated during and/or analysed during the current study will be available upon request from the CIs and the Sponsor: After the trial has been reported, the de-identified individual participant data that underlies the results will be available on request from the Chief Investigators and the Sponsor, along with supplementary files as required (e.g., data dictionaries, analysis code, etc.). Data will be shared with (or access to the data will be provided to) requestors whose proposed use of the data has been approved by the CIs and Sponsor, under an appropriate data sharing agreement. It will not be possible to identify participants personally from any information shared. As part of consenting for the study, participants are asked to consent to the following clause ‘I understand that the information collected about me may be used to support other research in the future and may be shared anonymously with other researchers.’ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/03/2026: The study participating centres were updated.
24/10/2025: The public title was changed from "Improving nutrition for older adults in care homes" to "REFRESH study: nutRition intervEntions For malnouRished oldEr adultS in care Homes - A parallel, superiority, three-arm cluster randomised controlled trial".
17/10/2025: Contact details updated.
04/08/2025: Study's existence confirmed by the NIHR.
