- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195283
Novel Meal Service Improves Nutritional Intake
June 21, 2017 updated by: Radboud University Medical Center
A Novel In-hospital Meal Service Improves Protein and Energy Intake
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).
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
637
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the Departments of Gastroenterology, Urology/Gynaecology and Orthopedics.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
The type of meal service in the hospital (usual care)
|
|
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.
|
The type of meal service in the hospital (usual care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protein intake day 1 (gram)
Time Frame: 1 day
|
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)
Time Frame: 4 days
|
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)
Time Frame: 1 day
|
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)
Time Frame: 4 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' satisfaction (food appreciation and access to food)
Time Frame: 3 day
|
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
|
|
Patients' satisfaction (food quality and meal service)
Time Frame: 3 day
|
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
|
|
Change in nutritional status (body weight)
Time Frame: 4 days
|
Body weight (in kg) was measured prior to meals in the morning of the first and fourth day of oral intake.
|
4 days
|
|
Change in nutritional status (handgrip strength)
Time Frame: 4 days
|
Handgrip strength (in kg) was measured prior to meals in the morning of the first and fourth day of oral intake.
|
4 days
|
|
Nutritional status (height)
Time Frame: 1 day
|
Height (in cm) was measured prior to meals in the morning of the first day of oral intake.
|
1 day
|
|
Nutritional status (malnutrition universal screening tool)
Time Frame: 1 day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Geert Wanten, MD, PhD, MSc, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Lucy Kok RS. Ondervoeding onderschat. De kosten van ondervoeding en het rendement van medische voeding. Amsterdam: SEO economisch onderzoek, 2014.
- 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.
- Health Do. Essence of Care. Patient-focused benchmarks for clinical governance. Publication. London: NHS Modernisation Agency potDoH; 2003.
- 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.
- 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.
- 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.
- 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.
- Inspectie voor de Gezondheidszorg (IGZ). Kwaliteitsindicatoren 2014 basisset ziekenhuizen. Utrecht, The Netherlands: Ministerie van Volksgezondheid, Welzijn en Sport, 2014
- 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. Erratum In: Nutr Clin Pract. 2015 Aug;30(4):589.
- 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.
- Vera Todorovic CRaME. THE 'MUST' EXPLANATORY BOOKLET. A Guide to the 'Malnutrition Universal Screening Tool' ('MUST') for Adults. UK: 2011.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2015
Primary Completion (Actual)
December 22, 2016
Study Completion (Actual)
December 22, 2016
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 21, 2017
First Posted (Actual)
June 22, 2017
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 21, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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