Dietetics Education Focused on Malnutrition Prevention

NCT02892747 | Unknown

• 1 other identifier: K140703
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure (CHF)

Keywords

Chronic Heart Failure (CHF); Dietetics education; Malnutrition

Outcome Measures

Primary Outcomes (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

  6 months after randomization

Secondary Outcomes (9)

• Sodium intake will be evaluated by dietary survey on 24-hour recall and also by a rich-salt food frequency questionnaire

  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.

  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.

  8th day, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months

• EuroQol five dimensions questionnaire (EQ-5D)

  6 months after randomization

• Minnesota Living With Heart Failure Questionnaire (MLHFQ)

  6 months after randomization

Study Arms (2)

Educational Program for prevention of malnutrition

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Educational Program BEHAVIORAL

Educational Program for prevention of malnutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

Related Publications (5)

• Nicol SM, Carroll DL, Homeyer CM, Zamagni CM. The identification of malnutrition in heart failure patients. Eur J Cardiovasc Nurs. 2002 Jun;1(2):139-47. doi: 10.1016/s1474-5151(02)00005-1.

  PMID: 14622767 BACKGROUND

• Arcand J, Floras V, Ahmed M, Al-Hesayen A, Ivanov J, Allard JP, Newton GE. Nutritional inadequacies in patients with stable heart failure. J Am Diet Assoc. 2009 Nov;109(11):1909-13. doi: 10.1016/j.jada.2009.08.011.

  PMID: 19857633 BACKGROUND

• Curtis JP, Selter JG, Wang Y, Rathore SS, Jovin IS, Jadbabaie F, Kosiborod M, Portnay EL, Sokol SI, Bader F, Krumholz HM. The obesity paradox: body mass index and outcomes in patients with heart failure. Arch Intern Med. 2005 Jan 10;165(1):55-61. doi: 10.1001/archinte.165.1.55.

  PMID: 15642875 BACKGROUND

• Beck CA, Shah S. Research on health-related quality of life and cardiac conditions. Home Healthc Nurse. 2012 Jan;30(1):54-60. doi: 10.1097/NHH.0b013e31823aa740.

  PMID: 22173621 BACKGROUND

• Ferrante D, Varini S, Macchia A, Soifer S, Badra R, Nul D, Grancelli H, Doval H; GESICA Investigators. Long-term results after a telephone intervention in chronic heart failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) follow-up. J Am Coll Cardiol. 2010 Jul 27;56(5):372-8. doi: 10.1016/j.jacc.2010.03.049.

  PMID: 20650358 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Véronique BENEDYGA, Nutritionist

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique BENEDYGA, Nutritionist

CONTACT

(0)1 49 81 22 32; veronique.benedyga@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

FR (1)