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

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ClinicalTrials.gov Identifier: NCT02796521
Recruitment Status : Terminated (no more budget for personal to enrol participants)
First Posted : June 10, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Malnutrition Other: dietary counseling Other: nutritional workshop with enrichment during a meal Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of the Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition (and Their Caregivers) on Nutritional Status at Home
Study Start Date : March 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
control group
The control group will receive usual dietary counseling for enrichment.
Other: dietary counseling
Patients received individualized nutritional counseling encouraging them for enrichment

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.




Primary Outcome Measures :
  1. Improvement of nutritional status [ Time Frame: 4 months ]
    global Mini Nutritional Assessment


Secondary Outcome Measures :
  1. Effect of the workshop on nutritional items of Mini Nutritional Assessment [ Time Frame: 4 months ]
    specific nutritional items of Mini Nutritional Assessment

  2. Maintaining or improving weight [ Time Frame: 4 months ]
    Weight is determined with a Seca floor scale

  3. Improving ingesta qualitatively and quantitatively [ Time Frame: 4 months ]
    Ingesta are determined with a 24h-recall questionnaire

  4. Representations and motivations on eating habits [ Time Frame: 4 months ]
    Representations and motivations on eating habits are determined with a questionnaire with Likert responses

  5. Rate returns to the hospital and not programmed planned [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02796521


Locations
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France
CHU de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02796521     History of Changes
Other Study ID Numbers: 38RC14.177
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
malnutrition
aging
diet therapy

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders