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Efficacy of the Implementation of a Food and Nutritional Support Strategy Adapted to Dependent Elderly Subjects (RENES+)

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ClinicalTrials.gov Identifier: NCT02866474
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

Malnutrition particularly affects people who delegate the preparation of their meals with 46% of persons living at home and using a meals-on-wheels service, or those in old people's homes (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in independent persons (Aupalesens Survey). This proportion, which is particularly high, is essentially due to the absence or insufficient level of individual monitoring of the nutritional status of these "dependent" populations despite the different recommendations. EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data collection in 2012); in parallel, few professionals are really trained in the needs of the elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional follow-up is proposed (Guide 2012).

Symmetrically, the constant search to control costs in western healthcare systems has led managers to systematically reduce care costs, in particular those that are not directly related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In the collective catering services, there is, for example, a systematic effort to reduce daily "costs/materials", without measuring the global cost related to the efficacy of care.

The present work is part of the RENESSENS project: these studies will be conducted in two elderly populations, one living at home and receiving meals on wheels daily and a regular visit of a dietician, who will propose individual nutritional follow-up and the second living in an old people's home (EHPAD) that will benefit from the improved management of its catering service (good culinary practices, including specific training for personnel and meals adapted to the needs of residents). The principal aim of these two studies will be common and will be to evaluate the efficacy of this specific type of management of meals and nutrition compared with a reference meals-on-wheels service and a reference EHPAD.


Condition or disease Intervention/treatment Phase
Nutrition Elderly Dietary Supplement: population living at home with meals on wheels Dietary Supplement: population living in an EHPAD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Efficacy of the Implementation of a Food and Nutritional Support Strategy Adapted to Dependent Elderly Subjects: Controlled Trial.
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
- Puteaux or Paris for elderly persons Dietary Supplement: population living at home with meals on wheels
-Two EHPAD in Lyon for elderly persons living Dietary Supplement: population living in an EHPAD



Primary Outcome Measures :
  1. Evaluation of the nutritional status via the evolution of the Mini Nutritional Assessment (MNA) score including the evolution of weight [ Time Frame: Change with regard to Day 0, at three months , at six months ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • persons or their persons of trust who have given oral consent
  • Age ≥ 65 years
  • Persons living at home using a meals on wheels service every day or living in an old people's home (EHPAD)

Exclusion Criteria:

  • Persons without national health insurance cover
  • Persons requiring enteral or parenteral nutrition
  • Persons in an exclusion period for a previous study

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): NCT02866474


Contacts
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Contact: Patrick Manckoundia 03.80.29.39. 70 ext +33 patrick.manckoundia@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Not yet recruiting
Dijon, France, 21079
Contact: Patrick MANCKOUNDIA    03.80.29.39. 70 ext +33    patrick.manckoundia@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02866474     History of Changes
Other Study ID Numbers: VVW ancillaireANR 2014
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: July 2016