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

Primary Purpose

Malnutrition

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dietary counseling
nutritional workshop with enrichment during a meal
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition focused on measuring malnutrition, aging, diet therapy

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

control group

workshop group

Arm Description

The control group will receive usual dietary counseling for enrichment.

The workshop group will have informations about interest of foods. They will enrich a meal with foods which can easily be added without cooking.

Outcomes

Primary Outcome Measures

Improvement of nutritional status
global Mini Nutritional Assessment

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2016
Last Updated
October 10, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02796521
Brief Title
Evaluation of Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition on Nutritional Status at Home
Acronym
NutriPratiC
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
no more budget for personal to enrol participants
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
malnutrition, aging, diet therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
The control group will receive usual dietary counseling for enrichment.
Arm Title
workshop group
Arm Type
Other
Arm Description
The workshop group will have informations about interest of foods. They will enrich a meal with foods which can easily be added without cooking.
Intervention Type
Other
Intervention Name(s)
dietary counseling
Intervention Description
Patients received individualized nutritional counseling encouraging them for enrichment
Intervention Type
Other
Intervention Name(s)
nutritional workshop with enrichment during a meal
Intervention Description
Patients received in group nutritional informations for enrichment and are encouraged to try enrichment together during a meal.
Primary Outcome Measure Information:
Title
Improvement of nutritional status
Description
global Mini Nutritional Assessment
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Effect of the workshop on nutritional items of Mini Nutritional Assessment
Description
specific nutritional items of Mini Nutritional Assessment
Time Frame
4 months
Title
Maintaining or improving weight
Description
Weight is determined with a Seca floor scale
Time Frame
4 months
Title
Improving ingesta qualitatively and quantitatively
Description
Ingesta are determined with a 24h-recall questionnaire
Time Frame
4 months
Title
Representations and motivations on eating habits
Description
Representations and motivations on eating habits are determined with a questionnaire with Likert responses
Time Frame
4 months
Title
Rate returns to the hospital and not programmed planned
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15380901
Citation
Arnaud-Battandier F, Malvy D, Jeandel C, Schmitt C, Aussage P, Beaufrere B, Cynober L. Use of oral supplements in malnourished elderly patients living in the community: a pharmaco-economic study. Clin Nutr. 2004 Oct;23(5):1096-103. doi: 10.1016/j.clnu.2004.02.007.
Results Reference
background
PubMed Identifier
10950235
Citation
Boumendjel N, Herrmann F, Girod V, Sieber C, Rapin CH. Refrigerator content and hospital admission in old people. Lancet. 2000 Aug 12;356(9229):563. doi: 10.1016/S0140-6736(00)02583-6.
Results Reference
background
PubMed Identifier
12765661
Citation
Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.
Results Reference
background
PubMed Identifier
19925613
Citation
McMurdo ME, Price RJ, Shields M, Potter J, Stott DJ. Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial. J Am Geriatr Soc. 2009 Dec;57(12):2239-45. doi: 10.1111/j.1532-5415.2009.02568.x. Epub 2009 Nov 17.
Results Reference
background
PubMed Identifier
17275141
Citation
Persson M, Hytter-Landahl A, Brismar K, Cederholm T. Nutritional supplementation and dietary advice in geriatric patients at risk of malnutrition. Clin Nutr. 2007 Apr;26(2):216-24. doi: 10.1016/j.clnu.2006.12.002. Epub 2007 Feb 1.
Results Reference
background
PubMed Identifier
15684319
Citation
Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. doi: 10.1200/JCO.2005.02.054. Epub 2005 Jan 31.
Results Reference
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Evaluation of Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition on Nutritional Status at Home

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