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Dietetics Education Focused on Malnutrition Prevention (NUTRICOEUR)

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ClinicalTrials.gov Identifier: NCT02892747
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The intervention tested in this research project aims to reduce the unplanned hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic education program. This new program provides concrete solutions to patients by offering balanced menu ideas, adapted to their tastes and social-cultural habits, and a panel of recipes easy to make, inexpensive and tasty (despite the lack of salt). This new educational program should improve the dietary behavior of patients and reinforce the importance of dietary guidance in support of the CHF.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure (CHF) Behavioral: Educational Program Not Applicable

Detailed Description:

Context: The Chronic Heart Failure (CHF) is a major public health problem in terms of frequency, mortality and costs. The care integrates a low-salt diet to reduce fluid retention and cardiac decompensation. A large observational study (ODIN) shows the effectiveness of the Patient's Therapeutic Education program (PTE which provides learning management sodium intake by the intervention of a dietician, I-CARE) on reducing mortality. But prognosis of CHF remains serious leading to many hospitalizations. The nutritional status of patients with CHF is threatened by inadequate energy intake in connection with the low sodium diet and the rest energetic cost (REC). Malnutrition increases the risk of hospitalization because it causes an immune deficiency responsible for infections, bones weakness and impaired cognitive function.

Hypotheses: The investigators postulate that an educational diet focusing on prevention of malnutrition would reduce morbidity and improve quality of life for patients with CHF. For this, the investigators propose a new educational method: adding a personalized program monitoring energy and protein intake in addition to managing sodium intake, notably by offering personalized menu ideas and recipes.

Main objective: Demonstrate that a dietetic education program involving the prevention of malnutrition and managing sodium intake is more effective than the usual dietetic education (based only on management of sodium intake) on the frequency of unplanned hospitalizations (all causes ) at 6 months in CHF patients.

Secondary Objectives: Demonstrate the superiority of the dietetic education program involving the prevention of malnutrition and managing sodium intake over the usual dietetic education, by improving the nutritional status, the quality of life, the survival, the adherence to dietary recommendations and the reduction of hospitalizations for cardiac decompensation, the burden associated with low sodium diet and the costs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Dietetics Education Focused on Prevention of Malnutrition, on Reducing Morbidity and Improving Life Quality of Patients With Chronic Heart Failure (CHF): A Randomized Controlled Multicenter Clinical Trial
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Educational Program for prevention of malnutrition
In addition to the usual nutritional assessment, the patients in the experimental arm benefit of a personalized educational program for prevention of malnutrition. This program aims to monitor energy and protein intake in addition to managing sodium intake, notably by offering personalized menu ideas and recipes.
Behavioral: Educational Program
No Intervention: Control
In the control arm, patients are followed-up by the cardiologist and the nutritionist, and did not benefit of the personalized educational program for prevention of malnutrition.



Primary Outcome Measures :
  1. The number, duration, reason of hospitalization will be reported in a tracking booklet that will be given to the patient the day of his/her inclusion [ Time Frame: 6 months after randomization ]

Secondary Outcome Measures :
  1. Sodium intake will be evaluated by dietary survey on 24-hour recall and also by a rich-salt food frequency questionnaire [ Time Frame: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]
  2. Protein supply (g / day) will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire. [ Time Frame: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]
  3. Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall and also by a food frequency questionnaire. [ Time Frame: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]
  4. EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: 6 months after randomization ]
  5. Minnesota Living With Heart Failure Questionnaire (MLHFQ) [ Time Frame: 6 months after randomization ]
  6. Questionnaire "burden of diet" [ Time Frame: 6 months after randomization ]
  7. The compliance of dietary recommendations will be assessed by a tracking booklet in which food dietary recommendations will be reported [ Time Frame: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]
  8. The unplanned hospitalizations frequency for cardiac decompensation [ Time Frame: 6 months after randomization ]
  9. Death (cardiac cause included) [ Time Frame: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years old and over.
  • Patients with Chronic Heart Failure regardless of its severity stage: stage I to IV according to the New York Heart Association Classification (NYHC), and its age.
  • Patients having at least a cardiac failure on the last two years.
  • BMI ≥ 18,5 (≥ 21 if Age ≥ 70 years).
  • Patients with a prescription of dietary salt restriction, regardless of the amount of salt recommended.
  • Patients benefiting from the Patient Therapeutic Education Program (ICARE) focusing on managing sodium intake.
  • Patients informed of the study, and have given their oral non opposition.
  • Patients insured by a social security.

Exclusion Criteria:

  • Severe comorbidity (outside the CHF) affecting the prognosis at 3 months
  • Living in nursing homes or in housing home where it is difficult to manage their feed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892747


Contacts
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Contact: Véronique BENEDYGA, Nutritionist (0)1 49 81 22 32 ext +33 veronique.benedyga@aphp.fr

Locations
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France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Laetitia GREGOIRE    (0)1 49 81 41 64 ext +33    Laetitia.gregoire@aphp.fr   
Contact: Aroua ZRIBI    (0)1 49 81 47 87 ext +33    aroua.zribi@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Véronique BENEDYGA, Nutritionist Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02892747     History of Changes
Other Study ID Numbers: K140703
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic Heart Failure (CHF)
Dietetics education
Malnutrition
Additional relevant MeSH terms:
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Heart Failure
Malnutrition
Heart Diseases
Cardiovascular Diseases
Nutrition Disorders