NCT03195283

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
637

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

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

July 28, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

June 2, 2017

Last Update Submit

June 21, 2017

Conditions

Malnutrition

Keywords

meal serviceprotein intakesatisfactionhospitalized patients

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Patients' satisfaction (food appreciation and access to food)

    3 day

  • Patients' satisfaction (food quality and meal service)

    3 day

  • Change in nutritional status (body weight)

    4 days

  • Change in nutritional status (handgrip strength)

    4 days

  • Nutritional status (height)

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Traditional meal service

TMS consists of three meals served by nutritional assistants throughout the day. Preference for dinner can be indicated in the morning by the individual patient from a menu list with predefined choices for meat, potatoes/rice/pasta and vegetables with various portion sizes.

Other: Meal service

FoodforCare

FfC consists of a 6-meals per day service. At bedside, patients are offered one or more small protein-rich dishes from a choice of 3. Nutritional assistants play a key role in recommending and delivering these protein-rich meals and assist patient in choosing the most optimal dish, based on the patient's nutrition order in the electronic patient record.

Other: Meal service

Interventions

Meal serviceOTHER

The type of meal service in the hospital (usual care)

FoodforCareTraditional meal service

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the Departments of Gastroenterology, Urology/Gynaecology and Orthopedics.

You may qualify if:

  • Dutch speaking
  • Aged 18 years or older
  • Exclusively oral intake
  • Expected hospital stay of at least 1 day

You may not qualify if:

  • Patients with tube- or parenteral feeding
  • A language barrier
  • Considered to be too weak to adequately answer our questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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. doi: 10.1079/bjn20041258.

    PMID: 15533269BACKGROUND

  • Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.

    PMID: 18061312BACKGROUND

  • 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. doi: 10.1016/s0261-5614(03)00098-0.

    PMID: 12880610BACKGROUND

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

    BACKGROUND

  • Beck AM, Balknas UN, Furst P, Hasunen K, Jones L, Keller U, Melchior JC, Mikkelsen BE, Schauder P, Sivonen L, Zinck O, Oien 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. doi: 10.1054/clnu.2001.0494.

    PMID: 11534942BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 22378801BACKGROUND

  • 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.

    PMID: 19573957BACKGROUND

  • 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.

    PMID: 19477558BACKGROUND

  • 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.

    PMID: 23550781BACKGROUND

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

    BACKGROUND

  • 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. No abstract available.

    PMID: 21224430BACKGROUND

  • 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.

    PMID: 25613832BACKGROUND

  • 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.

    PMID: 23615623BACKGROUND

  • 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.

    PMID: 25474696BACKGROUND

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

    BACKGROUND

  • Dijxhoorn DN, van den Berg MGA, Kievit W, Korzilius J, Drenth JPH, Wanten GJA. A novel in-hospital meal service improves protein and energy intake. Clin Nutr. 2018 Dec;37(6 Pt A):2238-2245. doi: 10.1016/j.clnu.2017.10.025. Epub 2017 Nov 9.

    PMID: 29173893DERIVED

MeSH Terms

Conditions

MalnutritionPersonal Satisfaction

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Geert Wanten, MD, PhD, MSc

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 22, 2017

Study Start

July 28, 2015

Primary Completion

December 22, 2016

Study Completion

December 22, 2016

Last Updated

June 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share