NCT02517476

Brief Summary

The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the question about overall benefit or harm, but using a physio-pathological mechanistic approach, it also will explore and provide conclusive answers about whether, why, how, and in which patient populations nutritional therapy does and does not works.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,088

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

4.1 years

First QC Date

July 30, 2015

Last Update Submit

May 15, 2018

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • primary composite endpoint

    Number of participants with adverse events including 1. All-cause mortality 2. Admission to the intensive care unit 3. Unplanned hospital readmission after hospital discharge 4. Major complications including nosocomial infection or abscess requiring antibiotic treatment, respiratory failure with need for invasive or non-invasive ventilation, major cardiovascular event or pulmonary embolism, acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis), gastro-intestinal hemorrhage or intestinal perforation assessed by medical chart review and telephone interview 5. decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index assessed by patient interview on admission and after 30 days

    measured at day 30 by telephone interview

Secondary Outcomes (6)

  • Weight change

    measured at day 30 by telephone interview

  • lenght of hospital stay

    participants will be followed for the duration of hospital stay with an expected average of 10 days

  • Improvement in quality of life

    measured at days 30 and 180 by telephone interview

  • Combined safety endpoints in regard to side effects from nutritional therapy

    measured at day 30

  • new decubital ulcer

    assessed on the day of hospital discharge after an expected average of 10 days

  • +1 more secondary outcomes

Study Arms (2)

Nutritional support

EXPERIMENTAL

For the purpose of this study, we have developed nutritional guidelines by consensus and adapted to current guidelines (e.g., ESPEN, ASPEN). 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 (i.e. renal failure). They specify not only nutritional targets, but also escalation of the route (i.e. food fortification, oral, enteral, parenteral) if targets cannot be achieved (≤75%) every 5 hours. Nutritional goals are being assessed daily in patients in the intervention group.

Dietary Supplement: Nutritional therapy

Usual care ("appetite-guided") controls

NO INTERVENTION

In control patients, we will use conventional nutrition according to the ability and desire of the patient to eat, using standard care food provided by the hospital kitchen ("appetite-guided").

Interventions

Nutritional therapyDIETARY_SUPPLEMENT

Any nutritional product and route (i.e. food fortification, oral, enteral, parenteral) is possible to reach goals

Nutritional support

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • NRS ≥3 points
  • expected hospital LOS ≥5 days (as estimated by the treating physician team)
  • willingness to provide informed consent (see informed consent statement)

You may not qualify if:

  • initially admitted to critical care units (except intermediate care)
  • scheduled for surgery or in an immediate post-operative 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 one visit with a dietician in the last month)
  • who are hospitalized because of anorexia nervosa
  • in terminal condition (end of life situation)
  • hospitalized due to acute pancreatitis
  • hospitalized due to acute liver failure
  • cystic fibrosis
  • patients after gastric bypass operations
  • stem cell transplantation
  • any contraindication against nutritional therapy (i.e., enteral and/or parenteral)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic, Kantonsspital Aarau

Aarau, Canton of Aargau, 5000, Switzerland

Location

Related Publications (30)

  • Schuetz P. "Eat your lunch!" - controversies in the nutrition of the acutely, non-critically ill medical inpatient. Swiss Med Wkly. 2015 Apr 23;145:w14132. doi: 10.4414/smw.2015.14132. eCollection 2015.

    PMID: 25906253BACKGROUND

  • Schutz P, Bally M, Stanga Z, Keller U. Loss of appetite in acutely ill medical inpatients: physiological response or therapeutic target? Swiss Med Wkly. 2014 Apr 29;144:w13957. doi: 10.4414/smw.2014.13957. eCollection 2014.

    PMID: 24782139BACKGROUND

  • Wunderle C, Martin E, Wittig A, Tribolet P, Lutz TA, Koster-Hegmann C, Stanga Z, Mueller B, Schuetz P. Comparison of the inflammatory biomarkers IL- 6, TNF-alpha, and CRP to predict the effect of nutritional therapy on mortality in medical patients at risk of malnutrition : A secondary analysis of the randomized clinical trial EFFORT. J Inflamm (Lond). 2025 Apr 24;22(1):16. doi: 10.1186/s12950-025-00442-0.

    PMID: 40275239DERIVED

  • Tribolet P, Wunderle C, Kaegi-Braun N, Buchmueller L, Laager R, Stanga Z, Mueller B, Wagner KH, Schuetz P. Evaluating repeated handgrip strength measurements as predictors of mortality in malnourished hospitalized patients. Secondary analysis of a randomized controlled trial. Eur J Clin Nutr. 2025 Sep;79(9):897-903. doi: 10.1038/s41430-025-01618-w. Epub 2025 Apr 16.

    PMID: 40240521DERIVED

  • Diethelm J, Wunderle C, van Zanten ARH, Tribolet P, Stanga Z, Mueller B, Schuetz P. Urea-to-creatinine ratio as a biomarker for clinical outcome and response to nutritional support in non-critically ill patients: A secondary analysis of a randomized controlled trial. Clin Nutr ESPEN. 2025 Jun;67:242-249. doi: 10.1016/j.clnesp.2025.03.042. Epub 2025 Mar 21.

    PMID: 40122337DERIVED

  • Randegger S, Wunderle C, Johansen OE, Tribolet P, Pavlicek V, Braendle M, Henzen C, Thomann R, Neyer P, Stanga Z, Mueller B, Schuetz P. Low plasma pancreatic lipase as a novel predictor of nutritional target achievement and response to nutritional interventions in malnourished inpatients: Secondary analysis of a randomized clinical trial. Clin Nutr. 2025 Apr;47:196-203. doi: 10.1016/j.clnu.2025.02.029. Epub 2025 Feb 25.

    PMID: 40037114DERIVED

  • Buchmueller LC, Wunderle C, Laager R, Bernasconi L, Neyer PJ, Tribolet P, Stanga Z, Mueller B, Schuetz P. Association of phenylalanine and tyrosine metabolism with mortality and response to nutritional support among patients at nutritional risk: a secondary analysis of the randomized clinical trial EFFORT. Front Nutr. 2024 Nov 12;11:1451081. doi: 10.3389/fnut.2024.1451081. eCollection 2024.

    PMID: 39600719DERIVED

  • Wunderle C, Suter SS, Endner N, Haenggi E, Kaegi-Braun N, Tribolet P, Stanga Z, Mueller B, Schuetz P. Sex differences in clinical presentation, treatment response, and side effects of nutritional therapy among patients at nutritional risk: a secondary analysis of the randomized clinical trial EFFORT. Am J Clin Nutr. 2024 Nov;120(5):1225-1232. doi: 10.1016/j.ajcnut.2024.09.020. Epub 2024 Sep 21.

    PMID: 39307186DERIVED

  • Wunderle C, Ciobanu C, Ritz J, Tribolet P, Neyer P, Bernasconi L, Stanga Z, Mueller B, Schuetz P. Association of leucine and other branched chain amino acids with clinical outcomes in malnourished inpatients: a secondary analysis of the randomized clinical trial EFFORT. Eur J Clin Nutr. 2025 Jan;79(1):42-49. doi: 10.1038/s41430-024-01507-8. Epub 2024 Sep 8.

    PMID: 39245679DERIVED

  • Olpe T, Wunderle C, Bargetzi L, Tribolet P, Laviano A, Stanga Z, Prado CM, Mueller B, Schuetz P. Muscle matters: Prognostic implications of malnutrition and muscle health parameters in patients with cancer. A secondary analysis of a randomised trial. Clin Nutr. 2024 Sep;43(9):2255-2262. doi: 10.1016/j.clnu.2024.07.020. Epub 2024 Aug 2.

    PMID: 39181036DERIVED

  • Keller B, Wunderle C, Tribolet P, Stanga Z, Kaegi-Braun N, Mueller B, Schuetz P. Nutritional support in hospitalised patients with diabetes and risk for malnutrition: a secondary analysis of an investigator-initiated, Swiss, randomised controlled multicentre trial. BMJ Open. 2024 Aug 17;14(8):e084754. doi: 10.1136/bmjopen-2024-084754.

    PMID: 39153787DERIVED

  • Stumpf F, Wunderle C, Ritz J, Bernasconi L, Neyer P, Tribolet P, Stanga Z, Mueller B, Bischoff SC, Schuetz P. Prognostic implications of the arginine metabolism in patients at nutritional risk: A secondary analysis of the randomized EFFORT trial. Clin Nutr. 2024 Mar;43(3):660-673. doi: 10.1016/j.clnu.2024.01.012. Epub 2024 Jan 22.

    PMID: 38309228DERIVED

  • Wunderle C, Siegenthaler J, Seres D, Owen-Michaane M, Tribolet P, Stanga Z, Mueller B, Schuetz P. Adaptation of nutritional risk screening tools may better predict response to nutritional treatment: a secondary analysis of the randomized controlled trial Effect of early nutritional therapy on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT). Am J Clin Nutr. 2024 Mar;119(3):800-808. doi: 10.1016/j.ajcnut.2024.01.013. Epub 2024 Jan 28.

    PMID: 38290574DERIVED

  • Haenggi E, Kaegi-Braun N, Wunderle C, Tribolet P, Mueller B, Stanga Z, Schuetz P. Red blood cell distribution width (RDW) - A new nutritional biomarker to assess nutritional risk and response to nutritional therapy? Clin Nutr. 2024 Feb;43(2):575-585. doi: 10.1016/j.clnu.2024.01.001. Epub 2024 Jan 5.

    PMID: 38242035DERIVED

  • Durmisi M, Kaegi-Braun N, Muller NA, Wunderle C, Tribolet P, Stanga Z, Mueller B, Schuetz P. Association of admission cortisol levels with outcomes and treatment response in patients at nutritional risk : A secondary analysis of a randomized clinical trial. Nutr J. 2023 Nov 15;22(1):59. doi: 10.1186/s12937-023-00881-6.

    PMID: 37968689DERIVED

  • Boesiger F, Poggioli A, Netzhammer C, Bretscher C, Kaegi-Braun N, Tribolet P, Wunderle C, Kutz A, Lobo DN, Stanga Z, Mueller B, Schuetz P. Changes in serum albumin concentrations over 7 days in medical inpatients with and without nutritional support. A secondary post-hoc analysis of a randomized clinical trial. Eur J Clin Nutr. 2023 Oct;77(10):989-997. doi: 10.1038/s41430-023-01303-w. Epub 2023 Jul 7.

    PMID: 37419969DERIVED

  • Baumgartner A, Olpe T, Griot S, Mentil N, Staub N, Burn F, Schindera S, Kaegi-Braun N, Tribolet P, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Association of CT-based diagnosis of sarcopenia with prognosis and treatment response in patients at risk of malnutrition - A secondary analysis of the Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) trial. Clin Nutr. 2023 Feb;42(2):199-207. doi: 10.1016/j.clnu.2022.12.006. Epub 2022 Dec 22.

    PMID: 36603460DERIVED

  • Bretscher C, Buergin M, Gurzeler G, Kagi-Braun N, Gressies C, Tribolet P, Lobo DN, Evans DC, Stanga Z, Mueller B, Schuetz P; EFFORT study team. Association between prealbumin, all-cause mortality, and response to nutrition treatment in patients at nutrition risk: Secondary analysis of a randomized controlled trial. JPEN J Parenter Enteral Nutr. 2023 Mar;47(3):408-419. doi: 10.1002/jpen.2470. Epub 2023 Jan 27.

    PMID: 36587281DERIVED

  • Stalder L, Kaegi-Braun N, Gressies C, Gregoriano C, Tribolet P, Lobo DN, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Prospective validation of five malnutrition screening and assessment instruments among medical inpatients: Secondary analysis of a randomized clinical trial. Clin Nutr. 2022 Jun;41(6):1307-1315. doi: 10.1016/j.clnu.2022.04.025. Epub 2022 Apr 26.

    PMID: 35552050DERIVED

  • Struja T, Laczko E, Wolski W, Schlapbach R, Mueller B, Roschitzki B, Schuetz P. Association of proteomic markers with nutritional risk and response to nutritional support: A secondary pilot study of the EFFORT trial using an untargeted proteomics approach. Clin Nutr ESPEN. 2022 Apr;48:282-290. doi: 10.1016/j.clnesp.2022.01.035. Epub 2022 Feb 2.

    PMID: 35331503DERIVED

  • Kaegi-Braun N, Boesiger F, Tribolet P, Gomes F, Kutz A, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Lobo DN, Cederholm T, Mueller B, Schuetz P. Validation of modified GLIM criteria to predict adverse clinical outcome and response to nutritional treatment: A secondary analysis of a randomized clinical trial. Clin Nutr. 2022 Apr;41(4):795-804. doi: 10.1016/j.clnu.2022.02.009. Epub 2022 Feb 17.

    PMID: 35263688DERIVED

  • Bretschera C, Boesiger F, Kaegi-Braun N, Hersberger L, Lobo DN, Evans DC, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Admission serum albumin concentrations and response to nutritional therapy in hospitalised patients at malnutrition risk: Secondary analysis of a randomised clinical trial. EClinicalMedicine. 2022 Feb 11;45:101301. doi: 10.1016/j.eclinm.2022.101301. eCollection 2022 Mar.

    PMID: 35198927DERIVED

  • Hersberger L, Dietz A, Burgler H, Bargetzi A, Bargetzi L, Kagi-Braun N, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Individualized Nutritional Support for Hospitalized Patients With Chronic Heart Failure. J Am Coll Cardiol. 2021 May 11;77(18):2307-2319. doi: 10.1016/j.jacc.2021.03.232.

    PMID: 33958128DERIVED

  • Bargetzi A, Emmenegger N, Wildisen S, Nickler M, Bargetzi L, Hersberger L, Segerer S, Kaegi-Braun N, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Admission kidney function is a strong predictor for the response to nutritional support in patients at nutritional risk. Clin Nutr. 2021 May;40(5):2762-2771. doi: 10.1016/j.clnu.2021.03.013. Epub 2021 Mar 15.

    PMID: 33933742DERIVED

  • Kaegi-Braun N, Tribolet P, Baumgartner A, Fehr R, Baechli V, Geiser M, Deiss M, Gomes F, Kutz A, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Value of handgrip strength to predict clinical outcomes and therapeutic response in malnourished medical inpatients: Secondary analysis of a randomized controlled trial. Am J Clin Nutr. 2021 Aug 2;114(2):731-740. doi: 10.1093/ajcn/nqab042.

    PMID: 33829236DERIVED

  • Baumgartner A, Hasenboehler F, Cantone J, Hersberger L, Bargetzi A, Bargetzi L, Kaegi-Braun N, Tribolet P, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial. Clin Nutr. 2021 Apr;40(4):1843-1850. doi: 10.1016/j.clnu.2020.10.009. Epub 2020 Oct 10.

    PMID: 33081983DERIVED

  • Kaegi-Braun N, Tribolet P, Gomes F, Fehr R, Baechli V, Geiser M, Deiss M, Kutz A, Bregenzer T, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Mattmann S, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Six-month outcomes after individualized nutritional support during the hospital stay in medical patients at nutritional risk: Secondary analysis of a prospective randomized trial. Clin Nutr. 2021 Mar;40(3):812-819. doi: 10.1016/j.clnu.2020.08.019. Epub 2020 Sep 5.

    PMID: 32919819DERIVED

  • Merker M, Felder M, Gueissaz L, Bolliger R, Tribolet P, Kagi-Braun N, Gomes F, Hoess C, Pavlicek V, Bilz S, Sigrist S, Brandle M, Henzen C, Thomann R, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B, Schuetz P. Association of Baseline Inflammation With Effectiveness of Nutritional Support Among Patients With Disease-Related Malnutrition: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e200663. doi: 10.1001/jamanetworkopen.2020.0663.

    PMID: 32154887DERIVED

  • Schuetz P, Sulo S, Walzer S, Vollmer L, Stanga Z, Gomes F, Rueda R, Mueller B, Partridge J; EFFORT trial collaborators. Economic evaluation of individualized nutritional support in medical inpatients: Secondary analysis of the EFFORT trial. Clin Nutr. 2020 Nov;39(11):3361-3368. doi: 10.1016/j.clnu.2020.02.023. Epub 2020 Feb 25.

    PMID: 32147200DERIVED

  • Schuetz P, Fehr R, Baechli V, Geiser M, Deiss M, Gomes F, Kutz A, Tribolet P, Bregenzer T, Braun N, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brandle M, Benz C, Henzen C, Mattmann S, Thomann R, Brand C, Rutishauser J, Aujesky D, Rodondi N, Donze J, Stanga Z, Mueller B. Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. Lancet. 2019 Jun 8;393(10188):2312-2321. doi: 10.1016/S0140-6736(18)32776-4. Epub 2019 Apr 25.

    PMID: 31030981DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Philipp Schuetz, Prof. Dr.

    University Clinic, Kantonsspital Aarau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 7, 2015

Study Start

April 1, 2014

Primary Completion

May 15, 2018

Study Completion

May 16, 2018

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

CH(1)