MalnutritionNutriPratiCNCT02796521
Evaluation of Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition on Nutritional Status at Home
A study testing dietary counseling and nutritional workshop with enrichment during a meal in people with Malnutrition, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- dietary counseling and nutritional workshop with enrichment during a meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- malnourished patients or at risk of malnutrition
- coming back home after hospitalization
- affiliated to a social security system
- having given free, informed written consent
Who cannot join
- 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
Show all 9Show fewer
- Severe digestive or intestinal malabsorption
- Iterative nausea and vomiting
- Patients with rapidly progressive diseases (life expectancy less than 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Malnutrition
- Being tested
- dietary counseling, nutritional workshop with enrichment during a meal
- Keywords
- malnutrition, aging, diet therapy
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary counselingOther
Patients received individualized nutritional counseling encouraging them for enrichment
nutritional workshop with enrichment during a mealOther
Patients received in group nutritional informations for enrichment and are encouraged to try enrichment together during a meal.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | The control group will receive usual dietary counseling for enrichment. Receives: 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. Receives: Other: dietary counseling; Other: nutritional workshop with enrichment during a meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of nutritional status
global Mini Nutritional Assessment
Measured: 4 months
Secondary outcomes (5)
Effect of the workshop on nutritional items of Mini Nutritional Assessment
specific nutritional items of Mini Nutritional Assessment
Measured: 4 months
Maintaining or improving weight
Weight is determined with a Seca floor scale
Measured: 4 months
Improving ingesta qualitatively and quantitatively
Ingesta are determined with a 24h-recall questionnaire
Measured: 4 months
Representations and motivations on eating habits
Representations and motivations on eating habits are determined with a questionnaire with Likert responses
Measured: 4 months
Rate returns to the hospital and not programmed planned
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: no more budget for personal to enrol participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796521
- Sponsor's protocol ID
- 38RC14.177
- Acronym
- NutriPratiC
- Status last verified
- May 2016
- First submitted
- 1 Jun 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 15380901Boumendjel 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 10950235Correia 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 12765661McMurdo 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 19925613Persson 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 17275141Ravasco 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02796521
- Acronym / sponsor ID
- NutriPratiC / 38RC14.177
- Conditions
- Malnutrition
- Keywords
- malnutrition, aging, diet therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more budget for personal to enrol participants
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: dietary counselingThe control group will receive usual dietary counseling for enrichment. |
| workshop group | Other | Other: dietary counseling, Other: nutritional workshop with enrichment during a mealThe workshop group will have informations about interest of foods. They will enrich a meal with foods which can easily be added without cooking. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- malnourished patients or at risk of malnutrition
- coming back home after hospitalization
- affiliated to a social security system
- having given free, informed written consent
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary counselingPatients received individualized nutritional counseling encouraging them for enrichment | Other | control group, workshop group |
| nutritional workshop with enrichment during a mealPatients received in group nutritional informations for enrichment and are encouraged to try enrichment together during a meal. | Other | workshop group |
Primary outcome
Improvement of nutritional status
Time frame: 4 months
global Mini Nutritional Assessment
5 secondary outcomes
Effect of the workshop on nutritional items of Mini Nutritional Assessment
Time frame: 4 months
Maintaining or improving weight
Time frame: 4 months
Improving ingesta qualitatively and quantitatively
Time frame: 4 months
Representations and motivations on eating habits
Time frame: 4 months
Rate returns to the hospital and not programmed planned
Time frame: 4 months
Results and safety
The study was stopped early (reason given: no more budget for personal to enrol participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 15380901Arnaud-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.
- Background: PubMed 10950235Boumendjel 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.
- Background: PubMed 12765661Correia 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.
- Background: PubMed 19925613McMurdo 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.
- Background: PubMed 17275141Persson 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.
- Background: PubMed 15684319Ravasco 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.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Online Prehabilitation for Patients Awaiting Liver Transplantation
Cirrhosis, Liver, Liver Transplant Surgery
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary counseling and nutritional workshop with enrichment during a meal in people with Malnutrition, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no more budget for personal to enrol participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of nutritional status (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796521, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.