Introduction of an Enriched Evening Meal on the Feeding Behavior of Institutionalized Residents

Not Applicable

Completed

• Conditions: Institutionalization

• Registration Number: NCT02329613
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study was to evaluate and compare 6-month calorie intakes between a group of patients receiving a standard dinner and a group of patients whose evening meal is "improved"; compliance will be assessed on a food card with 5 levels of consumption: no (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per month for 6 months and will, from the total calorie intake of each dish, estimate calorie intake ingested per day on all meals of the day.

Detailed Description

The secondary objectives of this study are to evaluate the two groups for the following:

A. The difference between 0 and 6 months in: the patient's weight, calorie intake, serum prealbumin, albumin and CRP, blood sugar for diabetic patients.

B. Monthly evolution over 6 months: calorie intake, the patient's weight. C. The quarterly trend over 6 months: serum prealbumin, albumin and CRP, blood sugar for diabetic patients.

D. Comorbidities and mortality. E. the risk of morning hypoglycaemia for diabetic patients.

Study Timeline

• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Study Start: 2015-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• The subject or his/her representative must be given free and informed consent and must have signed the consent
• The subject must be affiliated with or beneficiary of a health insurance plan
• The subject has lived for at least 3 months in the institution
• The subject is fed by mouth only

Exclusion Criteria

• The subject is participating in another study
• The subject is in an exclusion period determined by a previous study
• The subject or his/her legal representative refuses to sign the consent
• It is not possible to correctly inform the subject or his/her representative

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total caloric ration for each dish	6 months
Meal compliance for 3 days	6 months
Ingested caloric intake	6 months

Secondary Outcome Measures

Name	Time	Method
Serum prealbumin	Month 6
Total caloric ration for each dish	Month 5
Serum albumin	Month 6
Ingested caloric intake	Month 5
Serum C reactive protein	Month 6
Meal compliance for 3 days	Month 5
Weight (kg)	Month 6
Glycated hemoglobin (HbA1C) for diabetic patients	Month 6
Presence/absence of comorbidities	Month 6
Mortality	Month 6
Capillary fasting blood glucose for diabetic patients	Month 6

Trial Locations

Locations (1)

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier; 🇫🇷 Nîmes, France