Improvement of Nutritional Status in Elderly Residents of Long-term Facilities (Nutrident)

Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)

Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven.

The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders
• Intervention / Treatment: Other: Dentary; Other: Nutrition; Other: Dentary + Nutrition

Detailed Description

Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design.

The "Dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.

The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Boulogne Billancourt, Ile de France, France, 92100
      • Centre gérontologie Les Abondances
    • Clichy, Ile de France, France, 92
      • Institut ROGUET
    • Colombes, Ile de France, France, 92700
      • AP-HP, Louis Mourier Hospital
    • Paris, Ile de France, France, 75018
      • Hôpital Bretonneau
    • Puteaux, Ile de France, France, 92
      • Hôpital de Puteaux
    • Sevran, Ile de France, France, 93
      • AP-HP, Hôpital René Muret-Bigottini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay

Exclusion Criteria:

• refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; usual care
Experimental: Dentary; Intervention: trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.	Other: Dentary; cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
Experimental: Nutrition; control of the administration of dietary prescriptions, incitement to eat.	Other: Nutrition; control of the administration of dietary prescriptions, incitement to eat.
Experimental: Dentary + nutrition; cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed) associated with control of the administration of dietary prescriptions, incitement to eat.	Other: Dentary + Nutrition; trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. associated with control of the administration of dietary prescriptions, incitement to eat.; Other Names: Dentary and Nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
comparison of GNRI mean-score between arms	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Philippe Charru, MD, Assistance Publique - Hôpitaux de Paris; Study Chair: Marysette FOLLIGUET, DDS, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: April 1, 2009
• First Posted (Estimate): April 2, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: nutritional status; elderly; long-term facilities
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: AOM07055; K070103 (Other Identifier: APHP); 2008-A00039-46 (Other Identifier: IDRCB)