Fortified Hospital Food as Nutritional Support (DHH)
Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
Background:
The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.
The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.
Methods:
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Copenhagen
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Herlev, Copenhagen, Danmark, 2730
- Herlev University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- patients at nutritional risk, according to the NRS-2002 system
- patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
- well-functioning gastrointestinal tract
- anticipated length of hospitalization of more than 3 days
Exclusion Criteria:
- terminal patients
- dysphagia
- food allergy or intolerance
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Nutritional intervention
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital")(intervention group).
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The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system.
The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital").
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
Tidsram: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
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The patients energy requirement will be estimated both from the factorial method and by Harris and Benedicts formula. Protein requirement will be 18E% of the energy requirement. Recording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days |
Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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handgrip strength
Tidsram: at day 3, 5 and 7
|
Handgrip strength (HGS)will be measured with a Jamar Digital Hand Dynanometer.
HGS will only be measured in the right hand because the right hand i significantly stronger in right-handed subjects and there is no significant difference between the two sides in left-handed subjects.
Subjects will be encouraged to perform maximal contractions three times with a 15-s interval and the average value will be recorded.
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at day 3, 5 and 7
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average daily energy and protein intake
Tidsram: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
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Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
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Use of tube feeding
Tidsram: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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Use of tube feeding will be registrated (yes or no and amount (ml.)
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The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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use of parenteral nutrition
Tidsram: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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Registration of use of parenteral nutrition (yes or no).
If yes how much (ml.).
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The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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length of stay
Tidsram: an expected average of 9 days.
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an expected average of 9 days.
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Samarbetspartners och utredare
Utredare
- Studierektor: Tina Munk, MSc., Herlev University Hospital, Denmark
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-1-2011-048
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