Dietetics Education Focused on Malnutrition Prevention (NUTRICOEUR)

November 19, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
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
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
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
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
EuroQol five dimensions questionnaire (EQ-5D)
Time Frame: 6 months after randomization
6 months after randomization
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time Frame: 6 months after randomization
6 months after randomization
Questionnaire "burden of diet"
Time Frame: 6 months after randomization
6 months after randomization
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
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
The unplanned hospitalizations frequency for cardiac decompensation
Time Frame: 6 months after randomization
6 months after randomization
Death (cardiac cause included)
Time Frame: 8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Véronique BENEDYGA, Nutritionist, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K140703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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