DASH Diet in Heart Failure Outpatients (DASH-HF)

DASH Diet in Heart Failure Pilot Study - Integration and Effectiveness of Medical Nutrition Therapy Counseling on DASH Diet in the Management of Heart Failure Patients in an Academic Outpatient Cardiology Clinic

The purpose of this study is to refine the classification of the effectiveness of the DASH diet for outpatient heart failure (HF) management, using behavioral, clinical, and laboratory correlative science approaches.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: DASH diet

Detailed Description

The overall objective of this pilot study is to refine the classification of the effectiveness of the DASH diet for outpatient HF management using behavioral, clinical, and laboratory correlative science approaches. The investigators will integrate the use and evaluation of DASH diet nutrition education in a clinical population using a pragmatic study approach. The investigators will assess dietary behavior change. The investigators will assess the medical effectiveness of the DASH diet to improve patient symptomology and clinical biomarkers. Exploratory investigations will involve metabolomics analyses of plasma samples for biomarker discovery of clinical phenotypes in HF patients, to characterize metabolic profiles related to dietary exposure.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francene Steinberg, PhD; Phone Number: 530 752 0160; Email: fmsteinberg@ucdavis.edu
• Study Contact Backup: Name: Brooke Wickman, MS; Email: bewickman@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Health Center - Cardiology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Heart Failure diagnosis
• Guideline directed medical therapy optimization on stable regimen at least 30 days

Exclusion Criteria:

• BMI < 18/5 kg/m squared
• cardiac cachexia
• end-stage renal disease or dialysis
• acute inflammatory condition
• uncontrolled arrhythmias or ischemia
• status post heart transplant or implanted left ventricular assist device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dietary Intervention Arm; Subjects will receive the active intervention of nutrition education and medical nutrition therapy counseling for dietary and behavioral lifestyle changes. The focus will be on DASH diet implementation and adherence for management of heart failure. The subjects will have 4 study visits with a Registered Dietitian over 6 months (visits at 1, 2, 3, and 6 months). Outcome measures will be assessed at baseline, 3 and 6 months.

Behavioral: DASH diet; Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	Dietary intake assessed by nutrient analysis of food records	Dietary intake at baseline
Dietary intake	Dietary intake assessed by nutrient analysis of food records	Dietary intake at 3 months
Dietary intake	Dietary intake assessed by nutrient analysis of food records	Dietary intake at 6 months
Diet score	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.	Dietary intake at baseline
Diet score	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.	Dietary intake at 3 months
Diet score	Dietary intake assessed by calculation of DASH diet score (Dietary Approaches to Stop Hypertension diet score). Minimum to Maximum values: 8-40 Higher scores mean better outcome and diet composition.	Dietary intake at 6 months
Blood Pressure	Blood Pressure assessed with systolic and diastolic pressure	Systolic and diastolic Blood Pressure at baseline
Blood Pressure	Blood Pressure assessed with systolic and diastolic pressure	Systolic and diastolic Blood Pressure at 3 months
Blood Pressure	Blood Pressure assessed with systolic and diastolic pressure	Systolic and diastolic Blood Pressure at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure clinical marker	proBNP will be assessed as a marker of severity of heart failure	proBNP at baseline
Heart Failure clinical marker	proBNP will be assessed as a marker of severity of heart failure	proBNP at 3 months
Heart Failure clinical marker	proBNP will be assessed as a marker of severity of heart failure	proBNP at 6 months
Patient report of HF symptoms	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.	KCCQ at baseline
Patient report of HF symptoms	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.	KCCQ at 3 months
Patient report of HF symptoms	Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.	KCCQ at 6 months
Patient report of eating habit self efficacy	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.	Eating Habits at Baseline
Patient report of eating habit self efficacy	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.	Eating Habits at 3 months
Patient report of eating habit self efficacy	Eating Habits Questionnaire will assess patient report of self efficacy for behavior change around DASH diet eating habits. Minimum to Maximum values:27-135. Higher value is better outcome.	Eating Habits at 6 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: American College of Cardiology
• Investigators: Principal Investigator: Francene Steinberg, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1770356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No