ELDRELYNUPOBANCT04696068
Nutritional Status in Patients Over 65 Years of Age and Meal Presentation
An observational study of ELDRELY, run by University Hospital, Caen.
Trial summary
The prevalence of undernutrition in hospitals is estimated between 30 and 40% and up to 50% in the elderly. The consequences of undernutrition are significant: complications, delayed healing, higher risk of infections, pressure ulcers, lengthening of the length of stay, higher readmission rate, increased mortality… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- ELDRELY
- What is being tested?
- Porcelain plates
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 15 Feb 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Each patient admitted to the internal medicine department will be included in the study, if he/she meets the inclusion criteria and does not present a excusion criterion.
Who may be able to join
- Patient 65 years of age or older
- Patient not having objected to his participation in the study
- Patient affiliated to a social security scheme
- French-speaking patient
Who cannot join
- Patient receiving a diet with double portions (a side dish of vegetables and a side of starches)
- Patient receiving a diet not including a main course at dinner
- Patient receiving cold meals
- Patient receiving a controlled residue or fiber diet
- Patient receiving a diet with a modified texture: chopped, milled, mixed, semi-liquid or liquid
- Patient for whom weight cannot be measured
Show all 11Show fewer
- Patient receiving partial or exclusive artificial nutrition (enteral or parenteral)
- Patient with a foreseeable length of stay of less than 6 days
- Patient with cognitive impairment
- Patient in accommodation in the care unit (risk of rapid transfer to the original department)
- For the second phase: patient who participated in the first phase of the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact on the Nutritional Status of Serving the Main Course on Porcelain Plates as a Replacement for Plastic Trays in Patients Over 65 Years of Age
The prevalence of undernutrition in hospitals is estimated between 30 and 40% and up to 50% in the elderly. The consequences of undernutrition are significant: complications, delayed healing, higher risk of infections, pressure ulcers, lengthening of the length of stay, higher readmission rate, increased mortality, reduced quality of life, etc. In addition, the cost of hospital malnutrition is high for the health system. As a result, undernutrition is one of the axes of action of the french National Health Nutrition Program 2019-2023 (PNNS4). It can appear during hospitalization or be pre-existing and worsen during hospitalization. It is due to an unfavorable balance between expenditure and energy intake. One of the causes is incomplete consumption of meals served in hospital. Studies have shown that the appearance of the meal is a hindrance to patients feeding.
At the Caen Normandie University Hospital, meals have been served to patients in plastic trays for thirteen years. The presentation of the meals is a significant factor in not consuming meals in the hospital. In addition to the problem of the presentation of meals, plastic trays pose ergonomic problems: their height hinders the cutting and the gripping of food, which is difficult for patients with gripping problems; they can also be difficult to open for these same patients. They also pose environmental problems: the waste generated is not currently recycled.
Read more
The investigators hypothesize that presenting the main course on porcelain plates would reduce undernutrition and limit food waste.
The investigators therefore propose a study with the aim of:
- Compare the assessment of the perception of dietary intakes of patients receiving dishes presented on porcelain plates (experimental group) with that of patients receiving dishes in plastic trays (current system - control group) on D6 ± 1 day;
- Compare the evolution of indicators of nutritional status or risk in elderly patients receiving meals presented in porcelain plates (experimental group) compared to those receiving meals presented in plastic trays (control group);
- Evaluate food intake and food waste in each of the two groups;
- Compare patient satisfaction with meals in the two groups.
- Conditions
- ELDRELY
- Being tested
- Porcelain plates
- Keywords
- malnutrition, aged, meal presentation, SEFI®, prealbumin
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcelain platesOther
The patients will receive the same food in another presentation : porcelain plates instead of plastic trays
| Study group | Role | What they receive |
|---|---|---|
| Control | The patients included in this group will receive meals with the usual presentation (plastic trays) during six days. Their data will be collected at day 1 and day 6. | |
| Experimental | The patients included in this group will receive the main course in porcelain plates during six days. Their data will be collected at day 1 and day 6. Receives: Other: Porcelain plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of food intake
Evaluation of food intake between the two groups on day 6 ± 1 using the SEFI® tool: scale from 0 ("I don't eat anything at all") to 10 ("I eat normally") or visual evaluation portions consumed
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start30 Sep 2022 (estimated)
- Primary completion15 Feb 2023 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ELDRELYStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myriam SCELLES, Mrs, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696068
- Sponsor's protocol ID
- 2020-A02315-34
- Acronym
- NUPOBA
- Status last verified
- Jul 2022
- First submitted
- 4 Jan 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Navarro DA, Boaz M, Krause I, Elis A, Chernov K, Giabra M, Levy M, Giboreau A, Kosak S, Mouhieddine M, Singer P. Improved meal presentation increases food intake and decreases readmission rate in hospitalized patients. Clin Nutr. 2016 Oct;35(5):1153-8. doi: 10.1016/j.clnu.2015.09.012. Epub 2015 Oct 9.
PubMed 26627844Hansen KV, Froiland CT, Testad I. Porcelain for All - a nursing home study. Int J Health Care Qual Assur. 2018 Aug 13;31(7):662-675. doi: 10.1108/IJHCQA-10-2016-0160.
PubMed 30354892Hiesmayr M, Schindler K, Pernicka E, Schuh C, Schoeniger-Hekele A, Bauer P, Laviano A, Lovell AD, Mouhieddine M, Schuetz T, Schneider SM, Singer P, Pichard C, Howard P, Jonkers C, Grecu I, Ljungqvist O; NutritionDay Audit Team. Decreased food intake is a risk factor for mortality in hospitalised patients: the NutritionDay survey 2006. Clin Nutr. 2009 Oct;28(5):484-91. doi: 10.1016/j.clnu.2009.05.013. Epub 2009 Jul 1.
PubMed 19573957Thibault R, Goujon N, Le Gallic E, Clairand R, Sebille V, Vibert J, Schneider SM, Darmaun D. Use of 10-point analogue scales to estimate dietary intake: a prospective study in patients nutritionally at-risk. Clin Nutr. 2009 Apr;28(2):134-40. doi: 10.1016/j.clnu.2009.01.003. Epub 2009 Feb 14.
PubMed 19223093
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Nutritional Status of Serving the Main Course on Porcelain Plates as a Replacement for Plastic Trays in Patients Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT04696068
- Acronym / sponsor ID
- NUPOBA / 2020-A02315-34
- Conditions
- ELDRELY
- Keywords
- malnutrition, aged, meal presentation, SEFI®, prealbumin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 6 Jan 2021 (actual)
- 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.
The prevalence of undernutrition in hospitals is estimated between 30 and 40% and up to 50% in the elderly. The consequences of undernutrition are significant: complications, delayed healing, higher risk of infections, pressure ulcers, lengthening of the length of stay, higher readmission rate, increased mortality, reduced quality of life, etc. In addition, the cost of hospital malnutrition is high for the health system. As a result, undernutrition is one of the axes of action of the french National Health Nutrition Program 2019-2023 (PNNS4). It can appear during hospitalization or be pre-existing and worsen during hospitalization. It is due to an unfavorable balance between expenditure and energy intake. One of the causes is incomplete consumption of meals served in hospital. Studies have shown that the appearance of the meal is a hindrance to patients feeding.
At the Caen Normandie University Hospital, meals have been served to patients in plastic trays for thirteen years. The presentation of the meals is a significant factor in not consuming meals in the hospital. In addition to the problem of the presentation of meals, plastic trays pose ergonomic problems: their height hinders the cutting and the gripping of food, which is difficult for patients with gripping problems; they can also be difficult to open for these same patients. They also pose environmental problems: the waste generated is not currently recycled.
The investigators hypothesize that presenting the main course on porcelain plates would reduce undernutrition and limit food waste.
The investigators therefore propose a study with the aim of:
- Compare the assessment of the perception of dietary intakes of patients receiving dishes presented on porcelain plates (experimental group) with that of patients receiving dishes in plastic trays (current system - control group) on D6 ± 1 day;
- Compare the evolution of indicators of nutritional status or risk in elderly patients receiving meals presented in porcelain plates (experimental group) compared to those receiving meals presented in plastic trays (control group);
- Evaluate food intake and food waste in each of the two groups;
- Compare patient satisfaction with meals in the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –The patients included in this group will receive meals with the usual presentation (plastic trays) during six days. Their data will be collected at day 1 and day 6. |
| Experimental | – | Other: Porcelain platesThe patients included in this group will receive the main course in porcelain plates during six days. Their data will be collected at day 1 and day 6. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Each patient admitted to the internal medicine department will be included in the study, if he/she meets the inclusion criteria and does not present a excusion criterion.
Key inclusion criteria (4 listed)
- Patient 65 years of age or older
- Patient not having objected to his participation in the study
- Patient affiliated to a social security scheme
- French-speaking patient
Key exclusion criteria (11 listed)
- Patient receiving a diet with double portions (a side dish of vegetables and a side of starches)
- Patient receiving a diet not including a main course at dinner
- Patient receiving cold meals
- Patient receiving a controlled residue or fiber diet
- Patient receiving a diet with a modified texture: chopped, milled, mixed, semi-liquid or liquid
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 |
|---|---|---|
| Porcelain platesThe patients will receive the same food in another presentation : porcelain plates instead of plastic trays | Other | Experimental |
Primary outcome
Assessment of food intake
Time frame: 6 days
Evaluation of food intake between the two groups on day 6 ± 1 using the SEFI® tool: scale from 0 ("I don't eat anything at all") to 10 ("I eat normally") or visual evaluation portions consumed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 26627844Navarro DA, Boaz M, Krause I, Elis A, Chernov K, Giabra M, Levy M, Giboreau A, Kosak S, Mouhieddine M, Singer P. Improved meal presentation increases food intake and decreases readmission rate in hospitalized patients. Clin Nutr. 2016 Oct;35(5):1153-8. doi: 10.1016/j.clnu.2015.09.012. Epub 2015 Oct 9.
- Background: PubMed 30354892Hansen KV, Froiland CT, Testad I. Porcelain for All - a nursing home study. Int J Health Care Qual Assur. 2018 Aug 13;31(7):662-675. doi: 10.1108/IJHCQA-10-2016-0160.
- Background: PubMed 19573957Hiesmayr M, Schindler K, Pernicka E, Schuh C, Schoeniger-Hekele A, Bauer P, Laviano A, Lovell AD, Mouhieddine M, Schuetz T, Schneider SM, Singer P, Pichard C, Howard P, Jonkers C, Grecu I, Ljungqvist O; NutritionDay Audit Team. Decreased food intake is a risk factor for mortality in hospitalised patients: the NutritionDay survey 2006. Clin Nutr. 2009 Oct;28(5):484-91. doi: 10.1016/j.clnu.2009.05.013. Epub 2009 Jul 1.
- Background: PubMed 19223093Thibault R, Goujon N, Le Gallic E, Clairand R, Sebille V, Vibert J, Schneider SM, Darmaun D. Use of 10-point analogue scales to estimate dietary intake: a prospective study in patients nutritionally at-risk. Clin Nutr. 2009 Apr;28(2):134-40. doi: 10.1016/j.clnu.2009.01.003. Epub 2009 Feb 14.
- Individual participant dataSharing planned: No
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.
Myriam SCELLES, Mrs principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
An observational study of ELDRELY, run by University Hospital, Caen.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myriam SCELLES, Mrs (+33231063023, scelles-m@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of food intake (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696068, which also lists 4 linked publications.
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 24 Aug 2022.