NCT03650686

Brief 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 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

August 27, 2018

Last Update Submit

August 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average percentage quantification of ingesta

    Over 3 consecutive days

Interventions

Method which consists in weighing precisely the main dish at the beginning and then end of meal using a SOEHNLE scale (+/- 1g).

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly persons hospitalised in geriatric rehabilitation follow-up care and in acute geriatric units

You may qualify if:

  • 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

You may not qualify if:

  • patient with enteral or parenteral nutrition
  • patient not affiliated to a social security scheme
  • end-of-life patient or palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

May 3, 2018

Primary Completion

May 1, 2019

Study Completion

December 1, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations