MalnutritionARC2NCT02626078
Assessment of Food Practices by Residents in Nursing Homes
An observational study of Malnutrition, run by Hospices Civils de Lyon at 8 sites in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- observation and interview of residents
- How many people
- 46 participants
- Where
- 8 sitesFrance
- Study dates
- 16 Apr 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The protocol will include 110 subjects recruited in nursing home in which they reside
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Les Volubilis
Décines-Charpieu, 69153
Les Cristallines
Lyon, 69003
Les Amandines
Lyon, 69005
La Vérandine
Lyon, 69008
Castellane
Rillieux-la-Pape, 69140
Les Alizés
Saint-Priest, 69802
Les Althéas
Vaulx-en-Velin, 69120
Les Acanthes
Vaulx-en-Velin, 69515
About this study
Official title: 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.
- Conditions
- Malnutrition
- Being tested
- observation and interview of residents
- Keywords
- Malnutrition, Food practices, Elderly, Nursing Home, Aging, Nutritional status, Quality of life
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation and interview of residentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| observation and interview of residents | residents will be observed over lunch and an interview will be held with each resident after lunch Receives: Other: observation and interview of residents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during lunch, an average of 30 minutes
Secondary outcomes (4)
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.
Measured: 24 hours
Nutritional status
The mini nutritional assessment (MNA) will be completed for grading the nutritional state of the residents.
Measured: during the 30 minutes of the interview
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
Measured: during lunch, an average of 30 minutes
health assessment of the resident at inclusion
a clinical examination will be made by the doctor
Measured: at the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start16 Apr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626078
- Sponsor's protocol ID
- 69HCL14_0433
- Acronym
- ARC2
- Status last verified
- Aug 2017
- First submitted
- 26 Nov 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Food Practices by Residents in Nursing Homes, Study of Relationship Between Food Intake and Nutritional Status.
- ClinicalTrials.gov ID
- NCT02626078
- Acronym / sponsor ID
- ARC2 / 69HCL14_0433
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Food practices, Elderly, Nursing Home, Aging, Nutritional status, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Apr 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation and interview of residents | – | Other: observation and interview of residentsresidents will be observed over lunch and an interview will be held with each resident after lunch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The protocol will include 110 subjects recruited in nursing home in which they reside
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation and interview of residentsResidents 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. | Other | observation and interview of residents |
Primary outcome
Assessment score of food practices
Time frame: 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.
4 secondary outcomes
Food intake (semi- quantitative estimation of the calorie and protein intakes).
Time frame: 24 hours
Nutritional status
Time frame: during the 30 minutes of the interview
study the interactions developed during the meal between the subject and his entourage
Time frame: during lunch, an average of 30 minutes
health assessment of the resident at inclusion
Time frame: at the inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Hospices Civils de Lyon at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment score of food practices (time frame: during lunch, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.