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.
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
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Virginie VAN WYMELBEKE, +33 380293155, virginie.vanwymelbeke@chu-dijon.fr
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.
- Conditions
- Elderly People, Breakfast
- 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.
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.
- First posted24 Sep 2018
- Study start5 Apr 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Give Back the Pleasure of Eating to the Dependent elderly_observational Study
- ClinicalTrials.gov ID
- NCT03681587
- Acronym / sponsor ID
- Petit-dejeuner / VVW 2017 Petit-dejeuner
- Conditions
- Elderly People, Breakfast
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly people residing in a retirement home
Key inclusion criteria (4 listed)
- persons over 75 years of age
- person residing in a retirement home
- orally fed person
- person who speaks and understands French
Key exclusion criteria (3 listed)
- person not affiliated to a social security scheme
- person requiring enteral or parenteral feeding
- dying person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control situationStandard 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. | Other | – |
| Experimental situationSalty/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. | Other | – |
Primary outcome
Change from Baseline of Ingesta weight at 2 months
Time frame: Month 0, 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.