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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02796521
Other study ID # 38RC14.177
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date February 2017

Study information

Verified date May 2016
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

At hospital, short term actions are used (adaptation of meals, oral supplementationā€¦) 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


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


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
dietary counseling
Patients received individualized nutritional counseling encouraging them for enrichment
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.

Locations

Country Name City State
France CHU de Grenoble Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (6)

Arnaud-Battandier F, Malvy D, Jeandel C, Schmitt C, Aussage P, Beaufrère 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Feb 1. — View 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. Epub 2005 Jan 31. — View Citation

Outcome

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