NCT02626078

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

November 26, 2015

Last Update Submit

August 18, 2017

Conditions

Keywords

MalnutritionFood practicesElderlyNursing HomeAgingNutritional statusQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Food intake (semi- quantitative estimation of the calorie and protein intakes).

    24 hours

  • Nutritional status

    during the 30 minutes of the interview

  • study the interactions developed during the meal between the subject and his entourage

    during lunch, an average of 30 minutes

  • health assessment of the resident at inclusion

    at the inclusion visit

Study Arms (1)

observation and interview of residents

residents will be observed over lunch and an interview will be held with each resident after lunch

Other: observation and interview of residents

Interventions

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.

observation and interview of residents

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The protocol will include 110 subjects recruited in nursing home in which they reside

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Les Volubilis

Décines-Charpieu, 69153, France

Location

Les Cristallines

Lyon, 69003, France

Location

Les Amandines

Lyon, 69005, France

Location

La Vérandine

Lyon, 69008, France

Location

Castellane

Rillieux-la-Pape, 69140, France

Location

Les Alizés

Saint-Priest, 69802, France

Location

Les Althéas

Vaulx-en-Velin, 69120, France

Location

Les Acanthes

Vaulx-en-Velin, 69515, France

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Observation

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 10, 2015

Study Start

April 16, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations