NCT04696068

Brief 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, 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

August 24, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

January 4, 2021

Last Update Submit

August 23, 2022

Conditions

Keywords

malnutritionagedmeal presentationSEFI®prealbumin

Outcome Measures

Primary Outcomes (1)

  • 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

    6 days

Study Arms (2)

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.

Other: Porcelain plates

Interventions

The patients will receive the same food in another presentation : porcelain plates instead of plastic trays

Experimental

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 26627844BACKGROUND
  • Hansen 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.

    PMID: 30354892BACKGROUND
  • Hiesmayr 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.

    PMID: 19573957BACKGROUND
  • Thibault 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.

    PMID: 19223093BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Myriam SCELLES, Mrs

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myriam SCELLES, Mrs

CONTACT

Elodie MORILLAND LECOQ, Mrs

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

September 30, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

August 24, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share