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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04696068
Other study ID # 2020-A02315-34
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 30, 2022
Est. completion date February 15, 2023

Study information

Verified date July 2022
Source University Hospital, Caen
Contact Myriam SCELLES, Mrs
Phone +33231063023
Email scelles-m@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The prevalence of undernutrition in hospitals is estimated between 30 and 40% and up to 50% in the elderly. The consequences of undernutrition are significant: complications, delayed healing, higher risk of infections, pressure ulcers, lengthening of the length of stay, higher readmission rate, increased mortality, reduced quality of life, etc. In addition, the cost of hospital malnutrition is high for the health system. As a result, undernutrition is one of the axes of action of the french National Health Nutrition Program 2019-2023 (PNNS4). It can appear during hospitalization or be pre-existing and worsen during hospitalization. It is due to an unfavorable balance between expenditure and energy intake. One of the causes is incomplete consumption of meals served in hospital. Studies have shown that the appearance of the meal is a hindrance to patients feeding. At the Caen Normandie University Hospital, meals have been served to patients in plastic trays for thirteen years. The presentation of the meals is a significant factor in not consuming meals in the hospital. In addition to the problem of the presentation of meals, plastic trays pose ergonomic problems: their height hinders the cutting and the gripping of food, which is difficult for patients with gripping problems; they can also be difficult to open for these same patients. They also pose environmental problems: the waste generated is not currently recycled. The investigators hypothesize that presenting the main course on porcelain plates would reduce undernutrition and limit food waste. The investigators therefore propose a study with the aim of: - Compare the assessment of the perception of dietary intakes of patients receiving dishes presented on porcelain plates (experimental group) with that of patients receiving dishes in plastic trays (current system - control group) on D6 ± 1 day; - Compare the evolution of indicators of nutritional status or risk in elderly patients receiving meals presented in porcelain plates (experimental group) compared to those receiving meals presented in plastic trays (control group); - Evaluate food intake and food waste in each of the two groups; - Compare patient satisfaction with meals in the two groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date February 15, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patient 65 years of age or older - Patient not having objected to his participation in the study - Patient affiliated to a social security scheme - French-speaking patient Exclusion Criteria: - Patient receiving a diet with double portions (a side dish of vegetables and a side of starches) - Patient receiving a diet not including a main course at dinner - Patient receiving cold meals - Patient receiving a controlled residue or fiber diet - Patient receiving a diet with a modified texture: chopped, milled, mixed, semi-liquid or liquid - Patient for whom weight cannot be measured - Patient receiving partial or exclusive artificial nutrition (enteral or parenteral) - Patient with a foreseeable length of stay of less than 6 days - Patient with cognitive impairment - Patient in accommodation in the care unit (risk of rapid transfer to the original department) - For the second phase: patient who participated in the first phase of the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Porcelain plates
The patients will receive the same food in another presentation : porcelain plates instead of plastic trays

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

References & Publications (4)

Hansen KV, Frøiland CT, Testad I. Porcelain for All - a nursing home study. Int J Health Care Qual Assur. 2018 Aug 13;31(7):662-675. doi: 10.1108/IJHCQA-10-2016-0160. — View Citation

Hiesmayr M, Schindler K, Pernicka E, Schuh C, Schoeniger-Hekele A, Bauer P, Laviano A, Lovell AD, Mouhieddine M, Schuetz T, Schneider SM, Singer P, Pichard C, Howard P, Jonkers C, Grecu I, Ljungqvist O; NutritionDay Audit Team. Decreased food intake is a risk factor for mortality in hospitalised patients: the NutritionDay survey 2006. Clin Nutr. 2009 Oct;28(5):484-91. doi: 10.1016/j.clnu.2009.05.013. Epub 2009 Jul 1. — View Citation

Navarro DA, Boaz M, Krause I, Elis A, Chernov K, Giabra M, Levy M, Giboreau A, Kosak S, Mouhieddine M, Singer P. Improved meal presentation increases food intake and decreases readmission rate in hospitalized patients. Clin Nutr. 2016 Oct;35(5):1153-8. doi: 10.1016/j.clnu.2015.09.012. Epub 2015 Oct 9. — View Citation

Thibault R, Goujon N, Le Gallic E, Clairand R, Sébille V, Vibert J, Schneider SM, Darmaun D. Use of 10-point analogue scales to estimate dietary intake: a prospective study in patients nutritionally at-risk. Clin Nutr. 2009 Apr;28(2):134-40. doi: 10.1016/j.clnu.2009.01.003. Epub 2009 Feb 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of food intake Evaluation of food intake between the two groups on day 6 ± 1 using the SEFI® tool: scale from 0 ("I don't eat anything at all") to 10 ("I eat normally") or visual evaluation portions consumed 6 days
See also
  Status Clinical Trial Phase
Completed NCT05579457 - Physical Performance Levels and Social Participation in Elderly Living In Urban and Rural Areas