- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05239442
Engaging Elderly People Living in Institutions in Eating Situations (ENGAGE)
Several recent studies have revealed a significant under-consumption of food in hospitals and nursing homes. For instance, at the Dijon University Hospital, 8 out of 10 patients consume less than 80% of the meals served. This has two consequences: an increase in the risk of malnutrition (some patients leave the hospital in such a poor nutritional state that they must be re-hospitalized within six months) and significant food waste. At the heart of this problem, the taste of the food is the subject of frequent and recurrent complaints from users. Although the food industry widely uses sensory methods to adapt its products to the taste of consumers, these methods are rarely used by the organizations that provide meals to care institutions.
The objective is to establish "taste commissions" in the daily practice in institutions for the elderly (hospital, nursing home), in order to improve the organoleptic quality of the meals served according to the expectations and preferences of the users. The principle of this system is to allow the users to taste the dishes produced by the kitchen of the establishment and to transmit these evaluations to the cooks so that they can rework the recipes according to the users' feedback.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Virginie VAN WYMELBEKE
- Номер телефона: 03 80 29 31 55
- Электронная почта: virginie.vanwymelbeke@chu-dijon.fr
Места учебы
-
-
-
Dijon, Франция, 21000
- Рекрутинг
- CHU Dijon Bourgogne
-
Контакт:
- Virginie VAN WYMELBEKE
- Номер телефона: 03 80 29 31 55
- Электронная почта: virginie.vanwymelbeke@chu-dijon.fr
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Hospitalized patients:
- Person hospitalized in one of the following departments: the endocrinology-diabetology department, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as the rehabilitation department, which are departments with an average length of stay sufficient to perform the study
- Person aged ≥ 50 years (this choice was made because more than 60% of the hospitalized population is currently over 50 years old)
- Person having given their oral agreement
- Person with an oral diet and eating without assistance
- Person with a normal texture diet
- For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE > 21).
Residents in nursing home (EHPAD):
- Person residing in EHPAD
- Person aged ≥ 65 years
- Person having given oral consent
- Person who is orally fed and self-feeding
- Person with a normal texture diet
- For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE > 21).
Facility staff for SWOT interviews:
- Person who has worked at the facility where the taste commissions were implemented at least 3 months previously.
- Person who gave oral consent
- Person between the ages of 18 and 60
Exclusion Criteria:
- Person at the end of life
- Person with an eating disorder
- Person with a significant chronic psychiatric disorder (psychosis, manic-depression).
- Person requiring enteral or parenteral nutrition.
- Person in a period of exclusion from a previous study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Другой: Patients
Hospital Patients: - Person hospitalized in one of the following departments: endocrinology-diabetology, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as in the rehabilitation department |
Evaluation of the daily meal once a week: Introduction on the different sensory dimensions of the food, hedonic rating for each component, indicate what pleases/what could be improved in the recipe. At 0, 3, 6 months:
|
Другой: Institutional staff
Person working in the establishment where the taste commissions have been in place for at least 3 months
|
Individual semi-guided face-to-face interview with an experimenter.
They will allow us to identify the positive and negative effects of the taste commissions in the establishment as well as the levers and difficulties encountered during the implementation of the taste commissions.
These interviews will be recorded using an audio device (dictaphone).
Their content will then be transcribed in full.
|
Другой: Residents
Patients residing in nursing home
|
Evaluation of the daily meal once a week: Introduction on the different sensory dimensions of the food, hedonic rating for each component, indicate what pleases/what could be improved in the recipe. At 0, 3, 6 months:
Individual semi-guided face-to-face interview with an experimenter.
They will allow us to identify the positive and negative effects of the taste commissions in the establishment as well as the levers and difficulties encountered during the implementation of the taste commissions.
These interviews will be recorded using an audio device (dictaphone).
Their content will then be transcribed in full.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
weight of consumed ingesta
Временное ограничение: Change from Baseline to 6 months
|
Change from Baseline to 6 months
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- VAN WYMELBEKE I-SITE 2017
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .