Improvement of Nutritional Status in Elderly Residents of Long-term Facilities

Nutrition Disorders Clinical Trial

— Nutrident  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873717
• Other study ID #: AOM07055
• Secondary ID: K0701032008-A000
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: July 25, 2012
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nutrition Disorders

Intervention

Other:
• Dentary
cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
• Nutrition
control of the administration of dietary prescriptions, incitement to eat.
• 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.

Locations

Country	Name	City	State
France	Centre gérontologie Les Abondances	Boulogne Billancourt	Ile de France
France	Institut ROGUET	Clichy	Ile de France
France	AP-HP, Louis Mourier Hospital	Colombes	Ile de France
France	Hôpital Bretonneau	Paris	Ile de France
France	Hôpital de Puteaux	Puteaux	Ile de France
France	AP-HP, Hôpital René Muret-Bigottini	Sevran	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of GNRI mean-score between arms		1 year	No