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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02626078
Other study ID # 69HCL14_0433
Secondary ID
Status Completed
Phase N/A
First received November 26, 2015
Last updated August 18, 2017
Start date April 16, 2015
Est. completion date March 2016

Study information

Verified date August 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observation and interview of residents
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.

Locations

Country Name City State
France Les Volubilis Décines Charpieu
France La Vérandine Lyon
France Les Amandines Lyon
France Les Cristallines Lyon
France Castellane Rillieux la Pape
France Les Alizés Saint Priest
France Les Acanthes Vaulx en Velin
France Les Althéas Vaulx-en-Velin

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment score of food practices 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
Secondary Food intake (semi- quantitative estimation of the calorie and protein intakes). 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
Secondary Nutritional status The mini nutritional assessment (MNA) will be completed for grading the nutritional state of the residents. during the 30 minutes of the interview
Secondary study the interactions developed during the meal between the subject and his entourage 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
Secondary health assessment of the resident at inclusion a clinical examination will be made by the doctor at the inclusion visit
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