Evaluation of Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition on Nutritional Status at Home (NutriPratiC)

October 10, 2018 updated by: University Hospital, Grenoble

Evaluation of the Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition (and Their Caregivers) on Nutritional Status at Home

At hospital, short term actions are used (adaptation of meals, oral supplementation…) to fight malnutrition. Oral supplementation can have a positive impact on weight gain. But actions should continue at home, particularly to maintain autonomy for elderly. The hypothesis is that practical workshop about enrichment and interest of foods can help malnourished patients to change their eating habits. The main goal of this study is to evaluate the effects of this workshop on improving nutritional status, measured by Mini Nutritional Assessment

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a mono center cohort study of a 4-months follow-up on elderly patients after hospitalization.

Nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit at 4 months at home. These parameters will be studied in two groups : nutritional workshop vs usual dietary counseling

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU de Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • malnourished patients or at risk of malnutrition
  • coming back home after hospitalization
  • affiliated to a social security system
  • having given free, informed written consent

Exclusion Criteria:

  • Mini Mental Score <18
  • Incapacitated adults and psychiatric inpatients
  • Diet indication requiring strict salt restriction
  • Severe swallowing difficulties
  • Patients with artificial nutrition (enteral or parenteral)
  • Impossibility to measure weight at home
  • Severe digestive or intestinal malabsorption
  • Iterative nausea and vomiting
  • Patients with rapidly progressive diseases (life expectancy less than 6 months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
The control group will receive usual dietary counseling for enrichment.
Other: dietary counseling
Patients received individualized nutritional counseling encouraging them for enrichment
Other: workshop group
The workshop group will have informations about interest of foods. They will enrich a meal with foods which can easily be added without cooking.
Other: dietary counseling
Patients received individualized nutritional counseling encouraging them for enrichment
Other: nutritional workshop with enrichment during a meal
Patients received in group nutritional informations for enrichment and are encouraged to try enrichment together during a meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of nutritional status
Time Frame: 4 months
global Mini Nutritional Assessment
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the workshop on nutritional items of Mini Nutritional Assessment
Time Frame: 4 months
specific nutritional items of Mini Nutritional Assessment
4 months
Maintaining or improving weight
Time Frame: 4 months
Weight is determined with a Seca floor scale
4 months
Improving ingesta qualitatively and quantitatively
Time Frame: 4 months
Ingesta are determined with a 24h-recall questionnaire
4 months
Representations and motivations on eating habits
Time Frame: 4 months
Representations and motivations on eating habits are determined with a questionnaire with Likert responses
4 months
Rate returns to the hospital and not programmed planned
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC14.177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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