Malnutrition Nutritional, Metabolic, Endocrine
Conditions
Interventions
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 poi
Sponsors
University of Plymouth
Eligibility
Sex/Gender
All
Age
65 Years to 120 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 12/06/2026: 1. Fed via feeding tube 2. Active cancer treatment or recent major surgery 3. Considered by the care home staff to be approaching the end of life, where participation in the study would not be appropriate. 4. Already receiving nutrition support (ONS or fortified meals) with individualised dietetic advice from a dietitian‡. ‡Residents will be eligible if they have been: 1. Prescribed ONS short term (e.g. after a hospital stay) and have not yet been reviewed by a dietitian. 2. Prescribed ONS not specifically for malnutrition (e.g. for wound healing, haemodialysis). 3. Prescribed ONS by or on the recommendation of a health professional other than a dietitian (e.g. nurse or GP). 4. Discharged from dietetic care but are still on ONS. _____ Previous key exclusion criteria as of 12/06/2026: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health-related quality of life (HRQoL) measured using EQ-5D-5L Proxy Version 2 at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public Contact. Refresh PenCTU
Outcome results
None listed