Engaging Elderly People Living in Institutions in Eating Situations (ENGAGE)

February 10, 2022 updated by: Centre Hospitalier Universitaire Dijon

Several recent studies have revealed a significant under-consumption of food in hospitals and nursing homes. For instance, at the Dijon University Hospital, 8 out of 10 patients consume less than 80% of the meals served. This has two consequences: an increase in the risk of malnutrition (some patients leave the hospital in such a poor nutritional state that they must be re-hospitalized within six months) and significant food waste. At the heart of this problem, the taste of the food is the subject of frequent and recurrent complaints from users. Although the food industry widely uses sensory methods to adapt its products to the taste of consumers, these methods are rarely used by the organizations that provide meals to care institutions.

The objective is to establish "taste commissions" in the daily practice in institutions for the elderly (hospital, nursing home), in order to improve the organoleptic quality of the meals served according to the expectations and preferences of the users. The principle of this system is to allow the users to taste the dishes produced by the kitchen of the establishment and to transmit these evaluations to the cooks so that they can rework the recipes according to the users' feedback.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hospitalized patients:

  • Person hospitalized in one of the following departments: the endocrinology-diabetology department, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as the rehabilitation department, which are departments with an average length of stay sufficient to perform the study
  • Person aged ≥ 50 years (this choice was made because more than 60% of the hospitalized population is currently over 50 years old)
  • Person having given their oral agreement
  • Person with an oral diet and eating without assistance
  • Person with a normal texture diet
  • For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE > 21).

Residents in nursing home (EHPAD):

  • Person residing in EHPAD
  • Person aged ≥ 65 years
  • Person having given oral consent
  • Person who is orally fed and self-feeding
  • Person with a normal texture diet
  • For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE > 21).

Facility staff for SWOT interviews:

  • Person who has worked at the facility where the taste commissions were implemented at least 3 months previously.
  • Person who gave oral consent
  • Person between the ages of 18 and 60

Exclusion Criteria:

  • Person at the end of life
  • Person with an eating disorder
  • Person with a significant chronic psychiatric disorder (psychosis, manic-depression).
  • Person requiring enteral or parenteral nutrition.
  • Person in a period of exclusion from a previous 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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Patients

Hospital Patients:

- Person hospitalized in one of the following departments: endocrinology-diabetology, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as in the rehabilitation department
Other: Taste Commission

Evaluation of the daily meal once a week:

Introduction on the different sensory dimensions of the food, hedonic rating for each component, indicate what pleases/what could be improved in the recipe.

Other: Evaluation of the taste commissions

At 0, 3, 6 months:

  • Food intake measurement, satisfaction measurement, and food waste measurement performed on 2 days (same week but not necessarily consecutive)
  • Assessment of nutritional status using the Mini-Nutritional Assessment (MNA)
Other: Institutional staff
Person working in the establishment where the taste commissions have been in place for at least 3 months
Other: Entretien SWOT
Individual semi-guided face-to-face interview with an experimenter. They will allow us to identify the positive and negative effects of the taste commissions in the establishment as well as the levers and difficulties encountered during the implementation of the taste commissions. These interviews will be recorded using an audio device (dictaphone). Their content will then be transcribed in full.
Other: Residents
Patients residing in nursing home
Other: Taste Commission

Evaluation of the daily meal once a week:

Introduction on the different sensory dimensions of the food, hedonic rating for each component, indicate what pleases/what could be improved in the recipe.

Other: Evaluation of the taste commissions

At 0, 3, 6 months:

  • Food intake measurement, satisfaction measurement, and food waste measurement performed on 2 days (same week but not necessarily consecutive)
  • Assessment of nutritional status using the Mini-Nutritional Assessment (MNA)
Other: Entretien SWOT
Individual semi-guided face-to-face interview with an experimenter. They will allow us to identify the positive and negative effects of the taste commissions in the establishment as well as the levers and difficulties encountered during the implementation of the taste commissions. These interviews will be recorded using an audio device (dictaphone). Their content will then be transcribed in full.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
weight of consumed ingesta
Time Frame: Change from Baseline to 6 months
Change from Baseline to 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Dijon

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAN WYMELBEKE I-SITE 2017

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.

Clinical Trials on Under-consumption of Food

Clinical Trials on Taste Commission

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings