CClinicalTrials.gg
TerminatedNCT02796521NutriPratiCUpdated Oct 15, 2018

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

An interventional study of dietary counseling and nutritional workshop with enrichment during a meal in Malnutrition, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Other

Why this study was terminated
no more budget for personal to enrol participants
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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

Read the 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

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Conditions studied

  • Malnutrition

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Keywords

  • malnutrition
  • aging
  • diet therapy
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 12 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Other
    control group

    The control group will receive usual dietary counseling for enrichment.

    Other: dietary counseling

  • Other
    workshop group

    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

  • Otherdietary counseling

    Patients received individualized nutritional counseling encouraging them for enrichment

  • Othernutritional workshop with enrichment during a meal

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

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What researchers measure

Primary outcomes

  1. Improvement of nutritional status

    global Mini Nutritional Assessment

    Time frame: 4 months

Secondary outcomes

  1. Effect of the workshop on nutritional items of Mini Nutritional Assessment

    specific nutritional items of Mini Nutritional Assessment

    Time frame: 4 months

  2. Maintaining or improving weight

    Weight is determined with a Seca floor scale

    Time frame: 4 months

  3. Improving ingesta qualitatively and quantitatively

    Ingesta are determined with a 24h-recall questionnaire

    Time frame: 4 months

  4. Representations and motivations on eating habits

    Representations and motivations on eating habits are determined with a questionnaire with Likert responses

    Time frame: 4 months

  5. Rate returns to the hospital and not programmed planned

    Time frame: 4 months

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Study locations

1 site
  • CHU de Grenoble
    Grenoble, 38043, France
08

References and documents

Publications

  • 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. PubMed 15380901 ↗
  • 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. PubMed 10950235 ↗
  • 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. PubMed 12765661 ↗
  • 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. PubMed 19925613 ↗
  • 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. PubMed 17275141 ↗
  • 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. PubMed 15684319 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02796521
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Jun 10, 2016
Start date
Mar 2015
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Oct 15, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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