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Elderly PeoplePetit-dejeunerNCT03681587

How to Give Back the Pleasure of Eating to the Dependent Elderly

An observational study of Elderly People and Breakfast, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Many public health recommendations and policies aim to combat malnutrition in the elderly. It must be noted that levels of malnutrition are high in the elderly with more than 70% of the dependent population at home or in institutions and 30 to 70% of elderly people in hospitals. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Elderly People, Breakfast
What is being tested?
Experimental situation
How many people
50 participants
Where
1 siteFrance
Study dates
5 Apr 2018to Dec 2018
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: elderly people residing in a retirement home

Who may be able to join

  • persons over 75 years of age
  • person residing in a retirement home
  • orally fed person
  • person who speaks and understands French

Who cannot join

  • person not affiliated to a social security scheme
  • person requiring enteral or parenteral feeding
  • dying person

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Chu Dijon Bourogne

    Dijon, 21000

    Virginie VAN WYMELBEKE, +33 380293155, virginie.vanwymelbeke@chu-dijon.fr

    Recruiting

Other trials in France

About this study

Official title: How to Give Back the Pleasure of Eating to the Dependent elderly_observational Study

Many public health recommendations and policies aim to combat malnutrition in the elderly. It must be noted that levels of malnutrition are high in the elderly with more than 70% of the dependent population at home or in institutions and 30 to 70% of elderly people in hospitals.

In hospitals, the collective catering system and the "medicalisation" of meals (diets, medicines, etc.) force patients to change their eating habits, and they are often faced with a lack of choice and a less pleasurable experience. These organizational constraints are particularly harmful for elderly patients who tend to be malnourished or at risk of malnutrition and who are often polypathological and polymedicated.

Read more

If eating is one of the only pleasures sometimes left to this fragile population, breakfast is one of the most appreciated meals of the day (after a fasting time >10h). It tends to follow the habits acquired at home and is mostly oriented towards sweet foods. However, it is not known whether different and more varied choices could change dietary directions and intakes.

Offering sweet and savoury foods can upset medical prescriptions, cultural habits and can go against what remains a patient need: the pleasure of eating.

Although some work in the medico-social field has been successfully carried out and has reported changes in dietary behaviour in a choice situation (buffet type) at breakfast, scientific studies have not yet been done in a retirement home environment. The objective of this project is to emphasize the sensory pleasure and commensality of breakfast. During this buffet meal, sweet and savoury foods will be offered. The idea is to detect if the variety will naturally direct individual choices towards the savory and/or sweet flavours and if it encourages an increase in caloric and protein intakes. Several studies have shown that sensory changes in the elderly can lead to changes in behaviour and food preferences. The decrease in the pleasure only accentuates the causes of malnutrition. Moreover, preconceived ideas reinforce the association between the elderly and a preference for sweet foods. However, no study has shown that the elderly find less pleasure in savory than sweet foods, especially at breakfast.

The research will be organized as follows:

Phase 1: follow-up of breakfast consumption by food weighing. This is a prospective study that will be carried out at Dijon University Hospital within the retirement home.

The consumption of each meal will be measured the day of the breakfast with savory and sweet options, and then two days after in usual conditions in the individual's room. The distribution, service and consumption methods will be consistent with the habits of the units where the investigation is taking place.

For each resident, food consumption will be recorded three times, at one month intervals over 2 non-consecutive days.

Phase 2: observations at breakfast time Pleasure evaluation - Feasibility - commensality - conviviality A SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis will be conducted for each type of environment and meals offered. This analysis will be done using established grids and semi-directive interviews with resource persons who are working in the field (the professionals involved), and with research support units. The professionals will be asked to complete various scales, of the Likert type, before and after the breakfasts included in the study.

Being tested
Control situation, Experimental situation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control situationOther

    Standard breakfast usually offered "monotonous control condition" at the retirement home: the time of distribution, the duration of ingestion and the composition will be habitual. This meal and subsequent meals will be measured over 3 consecutive days with observation periods at breakfast time in order to identify the variables of pleasure, feasibility, commensality and conviviality in 2 situations: alone in the room or with others in the dining room.

  • Experimental situationOther

    Salty/sweet breakfast "varied experimental situation": the time of distribution and the duration of mealtime will be open and the composition will be varied with sweet/savory foods. This meal and subsequent meals will be measured over 3 consecutive days with observation periods at breakfast time in order to identify the variables of pleasure, feasibility, commensality and conviviality in 2 situations: alone or in the room or with others in the dining room.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline of Ingesta weight at 2 months

    Measured: Month 0, 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2018
  2. Study start5 Apr 2018
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03681587
Sponsor's protocol ID
VVW 2017 Petit-dejeuner
Acronym
Petit-dejeuner
Status last verified
Sep 2018
First submitted
27 Aug 2018
Last updated
24 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Elderly People and Breakfast, run by Centre Hospitalier Universitaire Dijon at 1 site 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 4 inclusion and 3 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Virginie VAN WYMELBEKE (+33 380293155, virginie.vanwymelbeke@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline of Ingesta weight at 2 months (time frame: Month 0, 1 and 2). 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 24 Sep 2018.

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