Five, Plus Nuts and Beans for Kidneys

Not Applicable

Completed

Interventions: Behavioral: Coaching DASH group (C-DASH)
Behavioral: Self-Shopping DASH group (S-DASH)

Brief Summary: This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.

Detailed Description: This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD.

150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.

Recruitment & Eligibility

Inclusion Criteria

Self-identified African American race
Age 21 years or older
Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59 ml/min/1.73m2.
Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months).
Must have a systolic blood pressure of <=160 mmHg and a diastolic blood pressure of <=100 mmHg (average of two visits)
Be on stable doses of antihypertensive medications for a minimum of two months prior to randomization.

Exclusion Criteria

Cardiovascular (CV) event within 6 months
Chronic disease that might interfere with trial participation (e.g. stage 4 or 5 Chronic Kidney Disease, Estimated Glomerular Filtration Rate <30 ml/min/1.73m2)
Unwillingness or inability to adopt a DASH-like diet
Consumes over 14 alcoholic drinks per week
Poorly controlled diabetes (Hemoglobin A1c >9%).
Patients with a serum potassium >4.6 milliequivalent (mEq) /L45
Urine ACR ≥ 1,000 mg/g

Arm && Interventions

Group	Intervention	Description
Coaching DASH group (C-DASH)	Coaching DASH group (C-DASH)	The C-DASH group intervention will be a patient-tailored program, delivered by a study coach that is trained by a dietitian, which emphasizes key self-management behaviors - diet and self-monitoring. This group will receive advice from the study coach and purchase $30 worth of fresh fruits, vegetables, nuts and beans that are high in potassium on a weekly basis for the first four months.
Self-Shopping DASH group (S-DASH)	Self-Shopping DASH group (S-DASH)	The Self-Shopping DASH group will receive printed patient-centered materials on the DASH diet and chronic kidney disease. Participants will also receive $30/week allowance for the purchase of food and drinks of their choosing from a local grocer (Klein's ShopRite stores of Maryland) during the first four months. During the remainder of the study (months 5-12), the participants in this group will be asked to continue to follow the dietary advice provided but will not receive the food allowance.

Primary Outcome Measures

Name	Time	Method
Change in Urinary Albumin Excretion From Baseline to 4 Months	Baseline, 4 months	Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Secondary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure From Baseline to 4 Months	Baseline,4 months	Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Change in Systolic Blood Pressure From Baseline to 12 Months	Baseline, end of study (approximately 12 months)	Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
Change in Urinary Albumin Excretion From Baseline to 12 Months	Baseline, end of study (approximately 12 months)	Urine samples will be collected for ACR (albumin-to-creatinine ratio).