Clinical trial NCT02796521: Evaluation of Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition on Nutritional Status at Home
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
Overall status: TERMINATED
Phase: NA
Conditions: Malnutrition
Keywords: malnutrition
aging
diet therapy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 12
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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)

Primary outcomes:
measure: Improvement of nutritional status
timeFrame: 4 months
Secondary outcomes:
measure: Effect of the workshop on nutritional items of Mini Nutritional Assessment
timeFrame: 4 months
measure: Maintaining or improving weight
timeFrame: 4 months
measure: Improving ingesta qualitatively and quantitatively
timeFrame: 4 months
measure: Representations and motivations on eating habits
timeFrame: 4 months
measure: Rate returns to the hospital and not programmed planned
timeFrame: 4 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
Study officials:
References:
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.
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.
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.
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.
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.
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.