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

NCT02329613 | Completed

• 2 other identifiers: LOCAL/2014/BH-012014-A00509-38
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Institutionalization

Outcome Measures

Primary Outcomes (3)

• Total caloric ration for each dish

  6 months

• Meal compliance for 3 days

  6 months

• Ingested caloric intake

  6 months

Secondary Outcomes (45)

• 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

Study Arms (2)

Standard evening meal

ACTIVE COMPARATOR

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

Other: Standard evening meals.

Improved evening meal

EXPERIMENTAL

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

Interventions

Standard evening meals. OTHER

Patients will receive usual evening meals.

Standard evening meal

Improved evening meal 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.

Improved evening meal

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The subject is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, 30029, France

Location

Study Officials

• Sabine Rouvière, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

• Béatrice Hébert, Nurse

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2016-04

Locations

FR (1)