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
概览
- 阶段
- 不适用
- 干预措施
- DASH diet
- 疾病 / 适应症
- Heart Failure
- 发起方
- University of California, Davis
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Dietary intake
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •Heart Failure diagnosis
- •Guideline directed medical therapy optimization on stable regimen at least 30 days
排除标准
- •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
研究组 & 干预措施
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.
干预措施: DASH diet
结局指标
主要结局
Dietary intake
时间窗: Dietary intake at 6 months
Dietary intake assessed by nutrient analysis of food records
Blood Pressure
时间窗: Systolic and diastolic Blood Pressure at 6 months
Blood Pressure assessed with systolic and diastolic pressure
Diet score
时间窗: 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.
Dietary intake
时间窗: Dietary intake at baseline
Dietary intake assessed by nutrient analysis of food records
Dietary intake
时间窗: Dietary intake at 3 months
Dietary intake assessed by nutrient analysis of food records
Diet score
时间窗: 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
时间窗: 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.
Blood Pressure
时间窗: Systolic and diastolic Blood Pressure at baseline
Blood Pressure assessed with systolic and diastolic pressure
Blood Pressure
时间窗: Systolic and diastolic Blood Pressure at 3 months
Blood Pressure assessed with systolic and diastolic pressure
次要结局
- Patient report of HF symptoms(KCCQ at 6 months)
- Heart Failure clinical marker(proBNP at 6 months)
- Patient report of eating habit self efficacy(Eating Habits at 6 months)
- Heart Failure clinical marker(proBNP at baseline)
- Heart Failure clinical marker(proBNP at 3 months)
- Patient report of HF symptoms(KCCQ at baseline)
- Patient report of HF symptoms(KCCQ at 3 months)
- Patient report of eating habit self efficacy(Eating Habits at Baseline)
- Patient report of eating habit self efficacy(Eating Habits at 3 months)