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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873717
First Posted: April 2, 2009
Last Update Posted: July 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention
Nutrition Disorders Other: Dentary Other: Nutrition Other: Dentary + Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • comparison of GNRI mean-score between arms [ Time Frame: 1 year ]

Enrollment: 114
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Dentary and Nutrition
No Intervention: Control
usual care

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873717


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00873717     History of Changes
Other Study ID Numbers: AOM07055
K070103 ( Other Identifier: APHP )
2008-A00039-46 ( Other Identifier: IDRCB )
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: July 26, 2012
Last Verified: April 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
elderly
long-term facilities
nutritional status

Additional relevant MeSH terms:
Nutrition Disorders