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Novel Meal Service Improves Nutritional Intake

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ClinicalTrials.gov Identifier: NCT03195283
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Study Description
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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).

Condition or disease Intervention/treatment
Malnutrition Other: Meal service

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 Design
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Study Type : Observational
Actual Enrollment : 637 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel In-hospital Meal Service Improves Protein and Energy Intake
Actual Study Start Date : July 28, 2015
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Groups and Cohorts
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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.
 Other: Meal service
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.
 Other: Meal service
The type of meal service in the hospital (usual care)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Departments of Gastroenterology, Urology/Gynaecology and Orthopedics.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195283


Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Geert Wanten, MD, PhD, MSc Radboud University
More Information
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Publications:
Lucy Kok RS. Ondervoeding onderschat. De kosten van ondervoeding en het rendement van medische voeding. Amsterdam: SEO economisch onderzoek, 2014.
Health Do. Essence of Care. Patient-focused benchmarks for clinical governance. Publication. London: NHS Modernisation Agency potDoH; 2003.
Inspectie voor de Gezondheidszorg (IGZ). Kwaliteitsindicatoren 2014 basisset ziekenhuizen. Utrecht, The Netherlands: Ministerie van Volksgezondheid, Welzijn en Sport, 2014
Vera Todorovic CRaME. THE 'MUST' EXPLANATORY BOOKLET. A Guide to the 'Malnutrition Universal Screening Tool' ('MUST') for Adults. UK: 2011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03195283     History of Changes
Other Study ID Numbers: 2015-1805
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Radboud University:
meal service
protein intake
satisfaction
hospitalized patients
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders