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

Impact of the Introduction of a New Qualitative Composition of the Evening Meal on the Feeding Behavior of Institutionalized Residents of a Long-term Care Unit: a Randomized, Single Center Study

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.

Study Overview

• Status: Completed
• Conditions: Institutionalization
• Intervention / Treatment: Other: Standard evening meals.; Other: Improved evening meal

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 71 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard evening meal; Patients randomized to this arm will receive standard evening meals. Intervention: Standard evening meals.	Other: Standard evening meals.; Patients will receive usual evening meals.
Experimental: Improved evening meal; Patients randomized to this arm will receive improved evening meals. Improved meals will include enriched soup (with starches, butter, cheese or sour cream), a semi-liquid dairy dessert, fruit or a fruit dessert. Intervention: Improved evening meal	Other: Improved evening meal; Patients will receive improved evening meals. Improved meals will include enriched soup (with starches, butter, cheese or sour cream), a semi-liquid dairy dessert, fruit or a fruit dessert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total caloric ration for each dish	6 months
Meal compliance for 3 days	6 months
Ingested caloric intake	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total caloric ration for each dish	Baseline (days -7 to 0)
Total caloric ration for each dish	Month 1
Total caloric ration for each dish	Month 2
Total caloric ration for each dish	Month 3
Total caloric ration for each dish	Month 4
Total caloric ration for each dish	Month 5
Meal compliance for 3 days	Baseline (days -7 to 0)
Meal compliance for 3 days	Month 1
Meal compliance for 3 days	Month 2
Meal compliance for 3 days	Month 3
Meal compliance for 3 days	Month 4
Meal compliance for 3 days	Month 5
Ingested caloric intake	Baseline (days -7 to 0)
Ingested caloric intake	Month 1
Ingested caloric intake	Month 2
Ingested caloric intake	Month 3
Ingested caloric intake	Month 4
Ingested caloric intake	Month 5
Weight (kg)	Baseline (days -7 to 0)
Weight (kg)	Month 1
Weight (kg)	Month 2
Weight (kg)	Month 3
Weight (kg)	Month 4
Weight (kg)	Month 5
Weight (kg)	Month 6
Serum prealbumin	Baseline (days -7 to 0)
Serum prealbumin	Month 3
Serum prealbumin	Month 6
Serum albumin	Baseline (days -7 to 0)
Serum albumin	Month 3
Serum albumin	Month 6
Serum C reactive protein	Baseline (days -7 to 0)
Serum C reactive protein	Month 3
Serum C reactive protein	Month 6
Glycated hemoglobin (HbA1C) for diabetic patients	Baseline (days -7 to 0)
Glycated hemoglobin (HbA1C) for diabetic patients	Month 3
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 1
Capillary fasting blood glucose for diabetic patients	Month 2
Capillary fasting blood glucose for diabetic patients	Month 3
Capillary fasting blood glucose for diabetic patients	Month 4
Capillary fasting blood glucose for diabetic patients	Month 5
Capillary fasting blood glucose for diabetic patients	Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Sabine Rouvière, MD, Centre Hospitalier Universitaire de Nîmes; Study Director: Béatrice Hébert, Nurse, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2014/BH-01; 2014-A00509-38 (Other Identifier: RCB number)