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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Copenhagen
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Herlev, Copenhagen, Дания, 2730
- Herlev University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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handgrip strength
Временное ограничение: at day 3, 5 and 7
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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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: an expected average of 9 days.
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an expected average of 9 days.
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Соавторы и исследователи
Следователи
- Директор по исследованиям: Tina Munk, MSc., Herlev University Hospital, Denmark
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- H-1-2011-048
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