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

NCT ID: NCT02329613

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Institutionalization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard evening meal

Patients randomized to this arm will receive standard evening meals.

Intervention: Standard evening meals.

Group Type ACTIVE_COMPARATOR

Standard evening meals.

Intervention Type OTHER

Patients will receive usual evening meals.

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

Group Type EXPERIMENTAL

Improved evening meal

Intervention Type OTHER

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.

Interventions

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Standard evening meals.

Patients will receive usual evening meals.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Rouvière, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Béatrice Hébert, Nurse

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00509-38

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/BH-01

Identifier Type: -

Identifier Source: org_study_id

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