NCT02866474

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Last Updated

February 12, 2024

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

August 10, 2016

Last Update Submit

February 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the nutritional status via the evolution of the Mini Nutritional Assessment (MNA) score including the evolution of weight

    Change with regard to Day 0, at three months , at six months

Study Arms (2)

- Puteaux or Paris for elderly persons

OTHER
Dietary Supplement: population living at home with meals on wheels

-Two EHPAD in Lyon for elderly persons living

OTHER
Dietary Supplement: population living in an EHPAD

Interventions

- Puteaux or Paris for elderly persons
-Two EHPAD in Lyon for elderly persons living

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Persons without national health insurance cover
  • Persons requiring enteral or parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

Food Services

Intervention Hierarchy (Ancestors)

Food IndustryIndustryTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 15, 2016

Study Start

November 9, 2015

Primary Completion

March 7, 2018

Last Updated

February 12, 2024

Record last verified: 2018-06

Locations