Elderly PeoplePAMPILLENCT03650686
Validity, Reliability and Feasibility of an Automated Photographic Measurement/Assessment of Food Intake in the Hospitalized Elderly
An observational study of Elderly People and Food Intake Measurement, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Malnutrition affects 50% to 70% of hospitalized elderly people, and is all the more worrying in the elderly because of its clinical impact. A measurement of food consumption is essential to recognize needs, monitor the nutritional status of the elderly in hospital and implement specific therapeutic action such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elderly People, Food Intake Measurement
- What is being tested?
- Food weighing (gold standard), Automated photographic method (method to be evaluated) and Semi-quantitative method (routine method)
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2018to Dec 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: Elderly persons hospitalised in geriatric rehabilitation follow-up care and in acute geriatric units
Who may be able to join
- patient who has given oral consent to participate
- adult patient
- inpatient geriatric rehabilitation follow-up care (SSRG) and acute geriatric units
- patient eating alone or with help
Who cannot join
- patient with enteral or parenteral nutrition
- patient not affiliated to a social security scheme
- end-of-life patient or palliative care
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Corinne BUISSON, +33 380293776, corinne.buisson@chu-dijon.fr
About this study
Malnutrition affects 50% to 70% of hospitalized elderly people, and is all the more worrying in the elderly because of its clinical impact. A measurement of food consumption is essential to recognize needs, monitor the nutritional status of the elderly in hospital and implement specific therapeutic action such as supplements or an increase in energy-protein to combat malnutrition or the risk of malnourishment. Unfortunately, this measure is rarely done effectively in practice, keeping the patient in nutritional deficit, contributing to a risk of increased morbidity and mortality.
Although weighing food intake is the reference method, it is a routine burden for healthcare teams. To overcome these constraints in hospital environments, intake is estimated by food readings over three consecutive days using a semi-quantitative method. It should be noted that this method remains complex, imprecise and reserved only for the most malnourished patients. In recent years, the development of photographic methods has become an interesting alternative to the measurement by weight. Based on photographs taken before and after the meal in order to deduce what is actually ingested, these methods obtain results comparable to the weighing method, though there is still a number of limitations (need for human intervention, constraint to have standardized menus in weight and lack of nutritional management adapted to patients). To overcome these limitations, an automated photographic method based on modern techniques for automatic processing of 2D and 3D images coupled with techniques derived from artificial intelligence has recently been developed in the investigator's unit, but has not yet been validated.
The originality and innovation of this project lies in the automated analysis of the photos taken and the conversion into percentage of remaining food thanks to the design of algorithms for image preprocessing and neural classification by a 2D and 3D software (patent pending).
- Conditions
- Elderly People, Food Intake Measurement
- Being tested
- Food weighing (gold standard), Automated photographic method (method to be evaluated), Semi-quantitative method (routine method)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food weighing (gold standard)Other
Method which consists in weighing precisely the main dish at the beginning and then end of meal using a SOEHNLE scale (+/- 1g).
Automated photographic method (method to be evaluated)Other
The nursing staff will position the tray for automatic picture taking before and after the meal. Taking a photograph of the entire tray will allow the patient's identity to be identified by his meal card which will then be coded for analysis and the plate will be targeted at the time of the nutritional analysis by the software. This method will automatically provide the percentage of each main dish food consumed using an advanced image processing algorithm and an optimized artificial intelligence system that will recognize the food before and after consumption. Automatic processing and transfer will enable food intake to be collected.
Semi-quantitative method (routine method)Other
Staff will indicate whether 1, ¾, ½, ¼ or 0 (corresponding to 100%, 75%, 50% 25% or 0) of the food in the main course has been consumed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Average percentage quantification of ingesta
Measured: Over 3 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start3 May 2018
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 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
- NCT03650686
- Sponsor's protocol ID
- Buisson PHRIP 2017 PAMPILLE
- Acronym
- PAMPILLE
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability and Feasibility of an Automated Photographic Measurement/Assessment of Food Intake in the Hospitalized Elderly
- ClinicalTrials.gov ID
- NCT03650686
- Acronym / sponsor ID
- PAMPILLE / Buisson PHRIP 2017 PAMPILLE
- Conditions
- Elderly People, Food Intake Measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Aug 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.
Malnutrition affects 50% to 70% of hospitalized elderly people, and is all the more worrying in the elderly because of its clinical impact. A measurement of food consumption is essential to recognize needs, monitor the nutritional status of the elderly in hospital and implement specific therapeutic action such as supplements or an increase in energy-protein to combat malnutrition or the risk of malnourishment. Unfortunately, this measure is rarely done effectively in practice, keeping the patient in nutritional deficit, contributing to a risk of increased morbidity and mortality.
Although weighing food intake is the reference method, it is a routine burden for healthcare teams. To overcome these constraints in hospital environments, intake is estimated by food readings over three consecutive days using a semi-quantitative method. It should be noted that this method remains complex, imprecise and reserved only for the most malnourished patients. In recent years, the development of photographic methods has become an interesting alternative to the measurement by weight. Based on photographs taken before and after the meal in order to deduce what is actually ingested, these methods obtain results comparable to the weighing method, though there is still a number of limitations (need for human intervention, constraint to have standardized menus in weight and lack of nutritional management adapted to patients). To overcome these limitations, an automated photographic method based on modern techniques for automatic processing of 2D and 3D images coupled with techniques derived from artificial intelligence has recently been developed in the investigator's unit, but has not yet been validated.
The originality and innovation of this project lies in the automated analysis of the photos taken and the conversion into percentage of remaining food thanks to the design of algorithms for image preprocessing and neural classification by a 2D and 3D software (patent pending).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly persons hospitalised in geriatric rehabilitation follow-up care and in acute geriatric units
Key inclusion criteria (4 listed)
- patient who has given oral consent to participate
- adult patient
- inpatient geriatric rehabilitation follow-up care (SSRG) and acute geriatric units
- patient eating alone or with help
Key exclusion criteria (3 listed)
- patient with enteral or parenteral nutrition
- patient not affiliated to a social security scheme
- end-of-life patient or palliative care
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 |
|---|---|---|
| Food weighing (gold standard)Method which consists in weighing precisely the main dish at the beginning and then end of meal using a SOEHNLE scale (+/- 1g). | Other | – |
| Automated photographic method (method to be evaluated)The nursing staff will position the tray for automatic picture taking before and after the meal. Taking a photograph of the entire tray will allow the patient's identity to be identified by his meal card which will then be coded for analysis and the plate will be targeted at the time of the nutritional analysis by the software. This method will automatically provide the percentage of each main dish food consumed using an advanced image processing algorithm and an optimized artificial intelligence system that will recognize the food before and after consumption. Automatic processing and transfer will enable food intake to be collected. | Other | – |
| Semi-quantitative method (routine method)Staff will indicate whether 1, ¾, ½, ¼ or 0 (corresponding to 100%, 75%, 50% 25% or 0) of the food in the main course has been consumed. | Other | – |
Primary outcome
Average percentage quantification of ingesta
Time frame: Over 3 consecutive days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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 Food Intake Measurement, 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 29 Aug 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 Corinne BUISSON (+33 380293776, corinne.buisson@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average percentage quantification of ingesta (time frame: Over 3 consecutive days). 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 29 Aug 2018.