DASH-HF: DASH Diet in Heart Failure Outpatients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Dietary intake [Dietary intake at baseline]
Dietary intake assessed by nutrient analysis of food records
- Dietary intake [Dietary intake at 3 months]
Dietary intake assessed by nutrient analysis of food records
- Dietary intake [Dietary intake at 6 months]
Dietary intake assessed by nutrient analysis of food records
- Diet score [Dietary intake at baseline]
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.
- Diet score [Dietary intake at 3 months]
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.
- Diet score [Dietary intake at 6 months]
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.
- Blood Pressure [Systolic and diastolic Blood Pressure at baseline]
Blood Pressure assessed with systolic and diastolic pressure
- Blood Pressure [Systolic and diastolic Blood Pressure at 3 months]
Blood Pressure assessed with systolic and diastolic pressure
- Blood Pressure [Systolic and diastolic Blood Pressure at 6 months]
Blood Pressure assessed with systolic and diastolic pressure
Secondary Outcome Measures
- Heart Failure clinical marker [proBNP at baseline]
proBNP will be assessed as a marker of severity of heart failure
- Heart Failure clinical marker [proBNP at 3 months]
proBNP will be assessed as a marker of severity of heart failure
- Heart Failure clinical marker [proBNP at 6 months]
proBNP will be assessed as a marker of severity of heart failure
- Patient report of HF symptoms [KCCQ at baseline]
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
- Patient report of HF symptoms [KCCQ at 3 months]
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
- Patient report of HF symptoms [KCCQ at 6 months]
Kansas City Cardiomyopathy Questionnaire (KCCQ) will assess patient report of symptoms. Minimum to Maximum values: 0-100. Higher scores represent better outcome.
- Patient report of eating habit self efficacy [Eating Habits at Baseline]
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.
- Patient report of eating habit self efficacy [Eating Habits at 3 months]
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.
- Patient report of eating habit self efficacy [Eating Habits at 6 months]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UC Davis Health Center - Cardiology Department | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
- American College of Cardiology
Investigators
- Principal Investigator: Francene Steinberg, PhD, University of California, Davis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1770356