NCT02517476.

Trial name or title	Effect of early nutritional therapy on frailty, functional outcomes and recovery of undernourished medical inpatients trial (EFFORT)
Methods	Multicentre randomised clinical trial, Switzerland
Participants	Hospitalised adults at risk for undernutrition defined by the nutritional risk score (NRS 2002) and an expected hospital length of stay > 5 days, at nutritional risk according to screening tools. Expected number: 2000 ‐ 3000. Exclusion criteria: Initially admitted to critical care units (except intermediate care), scheduled for surgery or in an immediate postoperative state, unable to ingest oral nutrition and thus need for enteral or parenteral nutrition, admitted with, or scheduled for, total parenteral nutrition or tube‐feeding, currently under nutritional therapy (defined by at least 1 visit with a dietician in the last month), who are hospitalised because of anorexia nervosa, in terminal condition (end‐of‐life situation), hospitalised due to acute pancreatitis, hospitalised due to acute liver failure, earlier inclusion into this trial, cystic fibrosis, patients after gastric bypass operations, stem cell transplantation, any contraindication against nutritional therapy (i.e. enteral or parenteral or both)
Interventions	Experimental group: These guidelines specify a reinforced nutritional therapy strategy to cover nutritional requirements, focusing on nutritional targets based on the specific nutritional diagnoses defined by the IDNT. The nutritional guidelines may vary according to important medical diagnoses (e.g. renal failure). They specify not only nutritional targets, but also escalation of the route (e.g. food fortification, oral, enteral, parenteral) if targets cannot be achieved (≤ 75%) every 5 hours. Nutritional goals are being assessed daily in participants in the intervention group. Control group: Usual care ("appetite‐guided") controls
Outcomes	All‐cause mortality, admission to the ICU from the medical ward, major complications, unplanned hospital readmissions, decline in functional outcome from admission to day 30 assessed by Barthel`s index (‐10%); each single component of the primary endpoint, short‐term nutritional and functional outcomes from inclusion to day 10 or hospital discharge; hospital outcomes; 30‐day and 180‐day outcomes, Other safety endpoints including adverse gastrointestinal effects associated with nutritional therapy assessed daily until hospital discharge.
Starting date	July 30, 2015
Contact information	schuetzph@gmail.com
Notes	Status: Recruiting NCT02517476