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MalnutritionNCT03195283

Novel Meal Service Improves Nutritional Intake

An observational study of Malnutrition, run by Radboud University Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malnutrition
What is being tested?
Meal service
How many people
637 participants
Where
No sites listed yet
Study dates
28 Jul 2015to 22 Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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).

Read the 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.

Conditions
Malnutrition
Being tested
Meal service
Keywords
meal service, protein intake, satisfaction, hospitalized patients
Medical subject headings
Malnutrition, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meal serviceOther

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

Study groups in NCT03195283
Study groupRoleWhat they receive
Traditional meal serviceTMS 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.
Receives: Other: Meal service
FoodforCareFfC 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.
Receives: Other: Meal service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day

  2. 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.

    Measured: 4 days

  3. 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.

    Measured: 1 day

  4. 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.

    Measured: 4 days

Secondary outcomes (6)

  1. 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.

    Measured: 3 day

  2. 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.

    Measured: 3 day

  3. 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.

    Measured: 4 days

  4. 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.

    Measured: 4 days

  5. Nutritional status (height)

    Height (in cm) was measured prior to meals in the morning of the first day of oral intake.

    Measured: 1 day

  6. 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2017
  2. Study start28 Jul 2015
  3. Primary completion22 Dec 2016
  4. Study completion22 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03195283
Sponsor's protocol ID
2015-1805
Status last verified
May 2017
First submitted
2 Jun 2017
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15533269

  • 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.

    PubMed 18061312

  • 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.

    PubMed 12880610

  • 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.

    PubMed 11534942

  • 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.

    PubMed 22378801

  • 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.

    PubMed 19573957

  • 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.

    PubMed 19477558

  • 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.

    PubMed 23550781

  • Inspectie voor de Gezondheidszorg (IGZ). Kwaliteitsindicatoren 2014 basisset ziekenhuizen. Utrecht, The Netherlands: Ministerie van Volksgezondheid, Welzijn en Sport, 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. No abstract available.

    PubMed 21224430

  • 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.

    PubMed 25613832

  • 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.

    PubMed 23615623

  • 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.

    PubMed 25474696

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition, run by Radboud University Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protein intake day 1 (gram) (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03195283, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.

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