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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03681587
Other study ID # VVW 2017 Petit-dejeuner
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2018
Est. completion date December 2018

Study information

Verified date September 2018
Source Centre Hospitalier Universitaire Dijon
Contact Virginie VAN WYMELBEKE
Phone +33 380293155
Email virginie.vanwymelbeke@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- persons over 75 years of age

- person residing in a retirement home

- orally fed person

- person who speaks and understands French

Exclusion Criteria:

- person not affiliated to a social security scheme

- person requiring enteral or parenteral feeding

- dying person

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control situation
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 situation
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.

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline of Ingesta weight at 2 months Month 0, 1 and 2
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