NutRition intervEntions For malnouRished oldEr adultS in care Homes (REFRESH)
Malnutrition
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 home
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
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).