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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Institutionalization

Treatments: Other: Standard evening meals.; Other: Improved evening meal

Study type: Interventional

Funder types: Other

Identifiers

NCT02329613

LOCAL/2014/BH-01

2014-A00509-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Standard evening meal

Active Comparator group

Description:

Patients randomized to this arm will receive standard evening meals. Intervention: Standard evening meals.

Treatment:

Other: Standard evening meals.

Improved evening meal

Experimental group

Description:

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

Treatment:

Other: Improved evening meal