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 |
| IRAS number | 334241 |
| Secondary identifying numbers | CPMS 58561, NIHR160348 |
- Submission date
- 04/08/2025
- Registration date
- 16/10/2025
- Last edited
- 24/10/2025
- Recruitment status
- Not yet 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
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 | Health-related quality of life (HRQoL) measured using EQ-5D-5L Proxy Version 2 at 6 months |
| Secondary outcome measures | 1. Dementia-specific quality of life measured using (DEMQoL-CH) at 6 months post-randomisation 2. Nutritional status assessed using the Mini Nutritional Assessment (MNA) at 6 months post-randomisation 3. Weight (kg) measured at 6 months post-randomisation 4. Dietary intake measured using 3-day photographed food records and food record charts used to estimate nutrient content at 6 months post-randomisation 5. Functional limitations measured using the Modified Barthel Index (MBI) at 6 months post-randomisation 6. Acceptability and adherence measured using 3-day photographed food records and food record charts at 6 months post-randomisation 7. Morbidity measured using antibiotic usage at 6 months post-randomisation 8. Mortality measured using registered death records at 6 months and 12 months post-randomisation 9. EQ-5D-5L-proxy at 12 months post-randomisation 10. 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) at 6 and 12 months |
| Overall study start date | 01/01/2025 |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | All |
| Target number of participants | Planned Sample Size: 1530; UK Sample Size: 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
- England
- United Kingdom
Study participating centres
Brixham
TQ5 0LW
United Kingdom
Yeovil
BA20 2RG
United Kingdom
Paignton
TQ3 3JW
United Kingdom
Wellington
TA21 9HY
United Kingdom
Taunton
TA1 5HA
United Kingdom
Exmouth
EX8 2HE
United Kingdom
Newton Abbot
TQ13 9JS
United Kingdom
Paignton
TQ3 2DY
United Kingdom
Exeter
EX2 8TU
United Kingdom
Truro
TR1 3EB
United Kingdom
Leominster
HR6 0QJ
United Kingdom
Bewdley
DY12 2QQ
United Kingdom
Newport
TF10 7EQ
United Kingdom
Southam
CV47 2BL
United Kingdom
Worcester
WR5 3NF
United Kingdom
Wolverhampton
WV3 9JJ
United Kingdom
Birmingham
B37 6QZ
United Kingdom
Whitchurch
SY13 1SG
United Kingdom
Kidderminster
DY11 5PB
United Kingdom
Handsworth Wood
Birmingham
B20 1AD
United Kingdom
Christchurch
BH23 2GZ
United Kingdom
Weymouth
DT4 7LF
United Kingdom
Broadstone
BH18 8AL
United Kingdom
Poole
BH15 4HY
United Kingdom
Branksome Park
Poole
BH13 6JF
United Kingdom
Talbot Woods
Bournemouth
BH3 7AZ
United Kingdom
Westbury-on-trym
Bristol
BS10 7QD
United Kingdom
Bristol
BS9 1JA
United Kingdom
Chippenham
SN15 5BH
United Kingdom
Corston
Bath
BA2 9AE
United Kingdom
Sponsor information
University/education
Drake Circus
Plymouth
PL4 8AA
England
United Kingdom
| Phone | +44 1752588959 |
|---|---|
| research.governance@plymouth.ac.uk | |
| Website | https://www.plymouth.ac.uk/ |
"ROR" |
https://ror.org/008n7pv89 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| 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.’ |
Editorial Notes
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.
