A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents

Cluster randomised feasibility trial in six privately owned care homes in Solihull, West Midlands, England, recruiting older adult residents at risk of or with malnutrition based on MUST screening. Active intervention arms included FB (N=32) and ONS (N=29), with a standard care comparator; many residents had dementia or cognitive impairment.

The food-based arm used daily food fortification and added snacks to increase intake by about 600 kcal and 20 to 25 g protein per day, given orally through food over 6 months. The oral nutritional supplement arm used two liquid servings daily, targeting about 600 kcal and 24 g protein per day, with products such as Fortisip Bottle 200 ml, Fortisip Compact 125 ml, or Nutriplen 125 ml depending on home stock, also for 6 months, compared with standard care.

The study found the nutritional interventions were feasible and acceptable, but efficacy remained exploratory because the trial was not powered for clinical outcomes. At 3 months, BMI improved in both active arms while declining in standard care, with change scores of 0.16 for FB and 0.33 for ONS versus -0.55 for SC. Energy intake declined less in ONS than in SC or FB at 3 months, with changes of -99 kcal, -380 kcal, and -479 kcal, respectively. The authors concluded that a definitive trial is feasible, but better simple functional and clinical outcome measures are needed for care-home research.

Feasibility design with small arm sizes and no power for efficacy limits interpretation of the clinical findings. Outcome measurement was challenging in care homes, and the authors noted a lack of simple, clinically relevant functional measures. Baseline imbalance was present, including a higher proportion of high-risk residents in the FB arm, and some outcome data were incomplete or variably reported across time points.