- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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-
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Décines Charpieu, França, 69153
- Les Volubilis
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Lyon, França, 69003
- Les Cristallines
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Lyon, França, 69005
- Les Amandines
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Lyon, França, 69008
- La Vérandine
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Rillieux la Pape, França, 69140
- Castellane
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Saint Priest, França, 69802
- Les Alizés
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Vaulx en Velin, França, 69515
- Les Acanthes
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Vaulx-en-Velin, França, 69120
- Les Althéas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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observation and interview of residents
residents will be observed over lunch and an interview will be held with each resident after lunch
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Assessment score of food practices
Prazo: during lunch, an average of 30 minutes
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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.
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during lunch, an average of 30 minutes
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Food intake (semi- quantitative estimation of the calorie and protein intakes).
Prazo: 24 hours
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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.
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24 hours
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Nutritional status
Prazo: during the 30 minutes of the interview
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The mini nutritional assessment (MNA) will be completed for grading the nutritional state of the residents.
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during the 30 minutes of the interview
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study the interactions developed during the meal between the subject and his entourage
Prazo: during lunch, an average of 30 minutes
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A specific grid designed to easily capture different parameters characterizing the action of eating in community will be completed
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during lunch, an average of 30 minutes
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health assessment of the resident at inclusion
Prazo: at the inclusion visit
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a clinical examination will be made by the doctor
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at the inclusion visit
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 69HCL14_0433
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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-
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