Abstract
BackgroundProtein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%–42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability.MethodsTrial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20–25 g.ResultsThe primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite.ConclusionsThe complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this feasibility trial will be used to inform the development and design of a future cluster randomised controlled trial to compare food-based intervention with prescribed oral nutritional supplements (ONS) in the treatment of malnutrition within the care home population.Trial registrationCurrent Controlled Trials ISRCTN38047922 Electronic supplementary materialThe online version of this article (doi:10.1186/2055-5784-1-3) contains supplementary material, which is available to authorized users.
Highlights
Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life
The protocol was submitted to the Research and Development Department of the Heart of England NHS Foundation Trust for Research governance approval
Careful planning to overcome the challenges of UK care home-based research is essential to prepare and design a cluster randomised trial of adequate size and quality to evaluate the efficacy of nutrition support interventions
Summary
Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Often under recognised and under treated, protein energy malnutrition (PEM) develops when energy intake and/or protein intake chronically fail to meet the body’s nutritional requirements [1] Described as both a cause and a consequence of adverse outcomes, PEM predisposes individuals to disease and delays in recovery from illness [2]. Used dietetic techniques to enhance oral dietary intakes include food-based intervention (recipe enrichment or fortification to increase energy and/or protein density, flavour enhancement, provision of nourishing snacks and/or fortified drinks) and/or the use of prescribed oral nutritional supplements (ONS) [9], considered to be ‘dietary foods for special medical purposes’ (FSMPs) [10]. Few trials have evaluated the food-based approach and it remains unclear whether this intervention is able to improve clinical and functional outcomes for malnourished individuals [8,13,14]
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