- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02626078
Assessment of Food Practices by Residents in Nursing Homes (ARC2)
Assessment of Food Practices by Residents in Nursing Homes, Study of Relationship Between Food Intake and Nutritional Status.
Nutrition is an essential component of health and a key determinant of aging and quality of life of individuals. Malnutrition in the elderly is now recognized as a public health problem affecting nearly half of residents in nursing homes. The fight against malnutrition requires to rethink the meal in all its dimensions, beyond the nutritional needs. In order to improve practices of care at the elderly, the impact of environmental and social aspects of food in nursing homes has been assessed. The social environment and interactions during the meals are now identified as effective ways to stimulate food intake and increase feelings of well-being in the elderly.
The objectives of the study are to characterize the appreciation of food and social interactions during the meals and to study the relationships between the quality of food practices and nutritional status of the residents in nursing homes to improve their quality of life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Décines Charpieu, Francia, 69153
- Les Volubilis
-
Lyon, Francia, 69003
- Les Cristallines
-
Lyon, Francia, 69005
- Les Amandines
-
Lyon, Francia, 69008
- La Vérandine
-
Rillieux la Pape, Francia, 69140
- Castellane
-
Saint Priest, Francia, 69802
- Les Alizés
-
Vaulx en Velin, Francia, 69515
- Les Acanthes
-
Vaulx-en-Velin, Francia, 69120
- Les Althéas
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Men or women living in nursing homes
- Person able to consent and understand the study
- Person able to converse in French, answer to a questionnaire
- Person feeding orally with or without assistance
- Person having lunch in community
- Availability of assessment criteria in the medical file
Exclusion Criteria:
- Person with cachexia syndrome
- Person with severe dementia (MMS <20)
- Dependent person (GIR score 1 and 2)
- Person with severe disorders of neurological origin swallowing
- Person under artificial nutrition (enteral, parenteral)
- Person with acute infectious disease
- Person with unstable medical or psychological conditions that could lead to be non receptive or uncooperative during the study or could compromise the security or the participation of the subject in the study
- Person under trusteeship or deprived of their liberty by judicial or administrative decision
- at the end of life
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
observation and interview of residents
residents will be observed over lunch and an interview will be held with each resident after lunch
|
Residents will be observed during lunch to evaluate their behavior, verbal interactions between residents.
The food intake during 24 hours will be evaluated also.
In an interview after lunch, the appreciation of the meal by residents will be assessed by a questionnaire and the score of the nutritional state will be defined.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment score of food practices
Periodo de tiempo: during lunch, an average of 30 minutes
|
A questionnaire will be administered to the residents to target several criteria based on the assessment of the self-perception of the restaurant area, the hunger, the quality of food and services, the conviviality… A choice of four answers will be offered on each question to assess the level of appreciation of each criterion.
|
during lunch, an average of 30 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Food intake (semi- quantitative estimation of the calorie and protein intakes).
Periodo de tiempo: 24 hours
|
Visual estimation of the consumption of served portions, combined with the composition of each component of the 3 meals and snacks.
The potential use of oral nutritional supplements will be included.
Visual estimation of the consumption of portions shall be notified in a specific evaluation sheet (0, 25%, 50%, 75 % or 100% consumption of portions served) for each component of meal and snack.
|
24 hours
|
|
Nutritional status
Periodo de tiempo: during the 30 minutes of the interview
|
The mini nutritional assessment (MNA) will be completed for grading the nutritional state of the residents.
|
during the 30 minutes of the interview
|
|
study the interactions developed during the meal between the subject and his entourage
Periodo de tiempo: during lunch, an average of 30 minutes
|
A specific grid designed to easily capture different parameters characterizing the action of eating in community will be completed
|
during lunch, an average of 30 minutes
|
|
health assessment of the resident at inclusion
Periodo de tiempo: at the inclusion visit
|
a clinical examination will be made by the doctor
|
at the inclusion visit
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 69HCL14_0433
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .