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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Institutionalization

Intervention / Treatment
-----------------
* Other: Standard evening meals.
* Other: Improved evening meal


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard evening meal<br>Patients randomized to this arm will receive standard evening meals. Intervention: Standard evening meals. | Other: Standard evening meals.<br>* Patients will receive usual evening meals.<br>|
| Experimental: Improved evening meal<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |