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| Name | Class |
|---|---|
| American College of Cardiology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Intervention Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH diet | Behavioral | Nutrition education and counseling on DASH diet, behavioral and lifestyle modifications |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francene Steinberg, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health Center - Cardiology Department | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Single arm pragmatic trial with pre- and post- assessments
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| 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 |
| 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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |