Malnutrition Clinical Trial
— NutriPratiCOfficial title:
Evaluation of the Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition (and Their Caregivers) on Nutritional Status at Home
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 |
Verified date | May 2016 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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) |
Country | Name | City | State |
---|---|---|---|
France | CHU de Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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
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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