Clinical trial NCT02329613: Introduction of an Enriched Evening Meal on the Feeding Behavior of Institutionalized Residents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Institutionalization
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 48
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Total caloric ration for each dish
timeFrame: 6 months
measure: Meal compliance for 3 days
timeFrame: 6 months
measure: Ingested caloric intake
timeFrame: 6 months
Secondary outcomes:
measure: Total caloric ration for each dish
timeFrame: Baseline (days -7 to 0)
measure: Total caloric ration for each dish
timeFrame: Month 1
measure: Total caloric ration for each dish
timeFrame: Month 2
measure: Total caloric ration for each dish
timeFrame: Month 3
measure: Total caloric ration for each dish
timeFrame: Month 4
measure: Total caloric ration for each dish
timeFrame: Month 5
measure: Meal compliance for 3 days
timeFrame: Baseline (days -7 to 0)
measure: Meal compliance for 3 days
timeFrame: Month 1
measure: Meal compliance for 3 days
timeFrame: Month 2
measure: Meal compliance for 3 days
timeFrame: Month 3
measure: Meal compliance for 3 days
timeFrame: Month 4
measure: Meal compliance for 3 days
timeFrame: Month 5
measure: Ingested caloric intake
timeFrame: Baseline (days -7 to 0)
measure: Ingested caloric intake
timeFrame: Month 1
measure: Ingested caloric intake
timeFrame: Month 2
measure: Ingested caloric intake
timeFrame: Month 3
measure: Ingested caloric intake
timeFrame: Month 4
measure: Ingested caloric intake
timeFrame: Month 5
measure: Weight (kg)
timeFrame: Baseline (days -7 to 0)
measure: Weight (kg)
timeFrame: Month 1
measure: Weight (kg)
timeFrame: Month 2
measure: Weight (kg)
timeFrame: Month 3
measure: Weight (kg)
timeFrame: Month 4
measure: Weight (kg)
timeFrame: Month 5
measure: Weight (kg)
timeFrame: Month 6
measure: Serum prealbumin
timeFrame: Baseline (days -7 to 0)
measure: Serum prealbumin
timeFrame: Month 3
measure: Serum prealbumin
timeFrame: Month 6
measure: Serum albumin
timeFrame: Baseline (days -7 to 0)
measure: Serum albumin
timeFrame: Month 3
measure: Serum albumin
timeFrame: Month 6
measure: Serum C reactive protein
timeFrame: Baseline (days -7 to 0)
measure: Serum C reactive protein
timeFrame: Month 3
measure: Serum C reactive protein
timeFrame: Month 6
measure: Glycated hemoglobin (HbA1C) for diabetic patients
timeFrame: Baseline (days -7 to 0)
measure: Glycated hemoglobin (HbA1C) for diabetic patients
timeFrame: Month 3
measure: Glycated hemoglobin (HbA1C) for diabetic patients
timeFrame: Month 6
measure: Presence/absence of comorbidities
timeFrame: Month 6
measure: Mortality
timeFrame: Month 6
measure: Capillary fasting blood glucose for diabetic patients
timeFrame: Month 1
measure: Capillary fasting blood glucose for diabetic patients
timeFrame: Month 2
measure: Capillary fasting blood glucose for diabetic patients
timeFrame: Month 3
measure: Capillary fasting blood glucose for diabetic patients
timeFrame: Month 4
measure: Capillary fasting blood glucose for diabetic patients
timeFrame: Month 5
measure: Capillary fasting blood glucose for diabetic patients
timeFrame: Month 6
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Sabine Rouvière, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Béatrice Hébert, Nurse
role: STUDY_DIRECTOR
References: