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

NCT02796521 | Terminated

• 1 other identifier: 38RC14.177
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Malnutrition

Keywords

malnutrition; aging; diet therapy

Outcome Measures

Primary Outcomes (1)

• Improvement of nutritional status

  global Mini Nutritional Assessment

  4 months

Secondary Outcomes (5)

• Effect of the workshop on nutritional items of Mini Nutritional Assessment

  4 months

• Maintaining or improving weight

  4 months

• Improving ingesta qualitatively and quantitatively

  4 months

• Representations and motivations on eating habits

  4 months

• Rate returns to the hospital and not programmed planned

  4 months

Study Arms (2)

control group

OTHER

The control group will receive usual dietary counseling for enrichment.

Other: dietary counseling

workshop group

OTHER

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; Other: nutritional workshop with enrichment during a meal

Interventions

dietary counseling OTHER

Patients received individualized nutritional counseling encouraging them for enrichment

control group; workshop group

nutritional workshop with enrichment during a meal OTHER

Patients received in group nutritional informations for enrichment and are encouraged to try enrichment together during a meal.

workshop group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• malnourished patients or at risk of malnutrition
• coming back home after hospitalization
• affiliated to a social security system
• having given free, informed written consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU de Grenoble

Grenoble, 38043, France

Location

Related Publications (6)

• 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.

  PMID: 15380901 BACKGROUND

• 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.

  PMID: 10950235 BACKGROUND

• 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.

  PMID: 12765661 BACKGROUND

• 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.

  PMID: 19925613 BACKGROUND

• 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.

  PMID: 17275141 BACKGROUND

• 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.

  PMID: 15684319 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 10, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 15, 2018

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)