MalnutritionCNO_ALIMSNCT03588169
Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study
An observational study of Malnutrition and Oral Nutritional Supplementation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Oral Nutritional Supplementation
- What is being tested?
- semi-structured interviews
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2019to 28 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised in the endocrinology, digestive surgery, pneumology and geriatrics departments of the Dijon University Hospital, with a prescription for ONS
Who may be able to join
- patient who has given oral consent
- over 18 years
- orally fed
- with a prescription for ONS
- speaks and understands French
- hospital stay longer than 4 days
Who cannot join
- adult under tutelage
- pregnant or breastfeeding women
- cognitive disorders
- patient does not speak or understand French
Trial locations and contacts
1 site in 1 country.
About this study
Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.
The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.
- Conditions
- Malnutrition, Oral Nutritional Supplementation
- Being tested
- semi-structured interviews
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsDietary supplement
About 30 minutes and touching on the following subjects:
- perception of hospital meals
- patient representation of ONS
- taking ONS and feelings about it
| Study group | Role | What they receive |
|---|---|---|
| patients hospitalized at the Dijon University Hospital | Patients hospitalized in the endocrinology, digestive surgery, pneumology and geriatric units of the Dijon University Hospital with a prescription for ONS Receives: Dietary Supplement: semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured individual interviews
Measured: 1 day on inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start14 Jan 2019
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
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
- NCT03588169
- Sponsor's protocol ID
- BRINDISI 2018 CNO_ALIMS
- Acronym
- CNO_ALIMS
- Status last verified
- Oct 2019
- First submitted
- 4 Jul 2018
- Last updated
- 16 Oct 2019
- 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 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study
- ClinicalTrials.gov ID
- NCT03588169
- Acronym / sponsor ID
- CNO_ALIMS / BRINDISI 2018 CNO_ALIMS
- Conditions
- Malnutrition, Oral Nutritional Supplementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 17 Jul 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.
Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.
The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients hospitalized at the Dijon University Hospital | – | Dietary Supplement: semi-structured interviewsPatients hospitalized in the endocrinology, digestive surgery, pneumology and geriatric units of the Dijon University Hospital with a prescription for ONS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in the endocrinology, digestive surgery, pneumology and geriatrics departments of the Dijon University Hospital, with a prescription for ONS
Key inclusion criteria (6 listed)
- patient who has given oral consent
- over 18 years
- orally fed
- with a prescription for ONS
- speaks and understands French
Key exclusion criteria (4 listed)
- adult under tutelage
- pregnant or breastfeeding women
- cognitive disorders
- patient does not speak or understand French
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 |
|---|---|---|
| semi-structured interviewsAbout 30 minutes and touching on the following subjects: * perception of hospital meals * patient representation of ONS * taking ONS and feelings about it | Dietary supplement | patients hospitalized at the Dijon University Hospital |
Primary outcome
Semi-structured individual interviews
Time frame: 1 day on inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Malnutrition and Oral Nutritional Supplementation, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 16 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured individual interviews (time frame: 1 day on inclusion). 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 16 Oct 2019.