Nutritional Status in Patients Over 65 Years of Age and Meal Presentation (NUPOBA)

August 23, 2022 updated by: University Hospital, Caen

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
The patients will receive the same food in another presentation : porcelain plates instead of plastic trays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Myriam SCELLES, Mrs, University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2022

Primary Completion (Anticipated)

February 15, 2023

Study Completion (Anticipated)

February 15, 2023

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A02315-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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