Novel Meal Service Improves Nutritional Intake

Malnutrition Clinical Trial

Official title:

A Novel In-hospital Meal Service Improves Protein and Energy Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195283
• Other study ID #: 2015-1805
• Status: Completed
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 21, 2017
• Start date: July 28, 2015
• Est. completion date: December 22, 2016

Study information

• Verified date: May 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate whether a novel meal service FoodforCare (FfC), comprising 6-protein-rich meals a day following proactive advice from a nutritional assistant, improves dietary intake and patient satisfaction, compared to the traditional 3-meals a day service (TMS).

Description:

The investigators performed a quasi experimental study at medical (Gastroenterology) and surgical (Gynecology, Urology, Orthopedics) wards. Patients were offered TMS (July 2015 - May 2016; n=326) or FfC meal service (after stepwise introduction per ward from January 2016 - December 2016; n=311). Primary outcome was the mean percentage of protein and energy intake relative to requirements, between patients receiving TMS and those receiving FfC, on the first and fourth day of full oral intake. Patient satisfaction comprised rating of the experienced quality of the food and the meal service and by means of a validated questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: December 22, 2016
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dutch speaking

• Aged 18 years or older

• Exclusively oral intake

• Expected hospital stay of at least 1 day

Exclusion Criteria:

• Patients with tube- or parenteral feeding

• A language barrier

• Considered to be too weak to adequately answer our questions

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Meal service
The type of meal service in the hospital (usual care)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

References & Publications (16)

Beck AM, Balknäs UN, Fürst P, Hasunen K, Jones L, Keller U, Melchior JC, Mikkelsen BE, Schauder P, Sivonen L, Zinck O, Øien H, Ovesen L; Council of Europe (the Committee of Experts on Nutrition, Food Safety and Consumer Health of the Partial Agreement in the Social and Public Health Field). Food and nutritional care in hospitals: how to prevent undernutrition--report and guidelines from the Council of Europe. Clin Nutr. 2001 Oct;20(5):455-60. — View Citation

Dodds RM, Syddall HE, Cooper R, Benzeval M, Deary IJ, Dennison EM, Der G, Gale CR, Inskip HM, Jagger C, Kirkwood TB, Lawlor DA, Robinson SM, Starr JM, Steptoe A, Tilling K, Kuh D, Cooper C, Sayer AA. Grip strength across the life course: normative data from twelve British studies. PLoS One. 2014 Dec 4;9(12):e113637. doi: 10.1371/journal.pone.0113637. eCollection 2014. — View Citation

Flood A, Chung A, Parker H, Kearns V, O'Sullivan TA. The use of hand grip strength as a predictor of nutrition status in hospital patients. Clin Nutr. 2014 Feb;33(1):106-14. doi: 10.1016/j.clnu.2013.03.003. Epub 2013 Mar 27. — View Citation

Health Do. Essence of Care. Patient-focused benchmarks for clinical governance. Publication. London: NHS Modernisation Agency potDoH; 2003.

Hiesmayr M, Schindler K, Pernicka E, Schuh C, Schoeniger-Hekele A, Bauer P, Laviano A, Lovell AD, Mouhieddine M, Schuetz T, Schneider SM, Singer P, Pichard C, Howard P, Jonkers C, Grecu I, Ljungqvist O; NutritionDay Audit Team. Decreased food intake is a risk factor for mortality in hospitalised patients: the NutritionDay survey 2006. Clin Nutr. 2009 Oct;28(5):484-91. doi: 10.1016/j.clnu.2009.05.013. Epub 2009 Jul 1. — View Citation

Inspectie voor de Gezondheidszorg (IGZ). Kwaliteitsindicatoren 2014 basisset ziekenhuizen. Utrecht, The Netherlands: Ministerie van Volksgezondheid, Welzijn en Sport, 2014

Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. — View Citation

Lucy Kok RS. Ondervoeding onderschat. De kosten van ondervoeding en het rendement van medische voeding. Amsterdam: SEO economisch onderzoek, 2014.

Mueller C, Compher C, Ellen DM; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: Nutrition screening, assessment, and intervention in adults. JPEN J Parenter Enteral Nutr. 2011 Jan;35(1):16-24. doi: 10.1177/0148607110389335. — View Citation

Mulasi U, Kuchnia AJ, Cole AJ, Earthman CP. Bioimpedance at the bedside: current applications, limitations, and opportunities. Nutr Clin Pract. 2015 Apr;30(2):180-93. doi: 10.1177/0884533614568155. Epub 2015 Jan 22. Review. Erratum in: Nutr Clin Pract. 2015 Aug;30(4):589. — View Citation

Naithani S, Thomas JE, Whelan K, Morgan M, Gulliford MC. Experiences of food access in hospital. A new questionnaire measure. Clin Nutr. 2009 Dec;28(6):625-30. doi: 10.1016/j.clnu.2009.04.020. Epub 2009 May 27. — View Citation

Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. Epub 2007 Dec 3. Review. — View Citation

Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. — View Citation

van Bokhorst-de van der Schueren MA, Roosemalen MM, Weijs PJ, Langius JA. High waste contributes to low food intake in hospitalized patients. Nutr Clin Pract. 2012 Apr;27(2):274-80. doi: 10.1177/0884533611433602. Epub 2012 Feb 29. — View Citation

Vera Todorovic CRaME. THE 'MUST' EXPLANATORY BOOKLET. A Guide to the 'Malnutrition Universal Screening Tool' ('MUST') for Adults. UK: 2011.

Wall BT, van Loon LJ. Nutritional strategies to attenuate muscle disuse atrophy. Nutr Rev. 2013 Apr;71(4):195-208. doi: 10.1111/nure.12019. Epub 2013 Feb 28. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein intake day 1 (gram)	The percentage of protein intake (gram) relative to requirements (1.2 gram/kilogram bodyweight) on the first day of full oral intake.	1 day
Primary	Protein intake day 4 (gram)	The percentage of protein intake (gram) relative to requirements (1.2 gram/kilogram bodyweight) on the fourth day of full oral intake.	4 days
Primary	Energy intake day 1 (kcal)	The percentage of energy intake (kcal) relative to requirements (Harris & Benedict formula * 1.3) on the first day of full oral intake.	1 day
Primary	Energy intake day 4 (kcal)	The percentage of energy intake (kcal) relative to requirements (Harris & Benedict formula * 1.3) on the fourth day of full oral intake.	4 days
Secondary	Patients' satisfaction (food appreciation and access to food)	Patients completed a questionnaire on food appreciation and experiences regarding food access on the third day of full oral intake in the hospital.	3 day
Secondary	Patients' satisfaction (food quality and meal service)	Patients completed a questionnaire in which they rated the quality of the food and the meal service (scale 0-10) on the third day of full oral intake in the hospital.	3 day
Secondary	Change in nutritional status (body weight)	Body weight (in kg) was measured prior to meals in the morning of the first and fourth day of oral intake.	4 days
Secondary	Change in nutritional status (handgrip strength)	Handgrip strength (in kg) was measured prior to meals in the morning of the first and fourth day of oral intake.	4 days
Secondary	Nutritional status (height)	Height (in cm) was measured prior to meals in the morning of the first day of oral intake.	1 day
Secondary	Nutritional status (malnutrition universal screening tool)	Malnutrition universal screening tool (MUST)) was measured prior to meals in the morning of the first day of oral intake. Weight (kg) and height (cm) will be combined to report BMI in kg/m^2.	1 day