Five, Plus Nuts and Beans for Kidneys

Johns Hopkins University

Status: Completed

Conditions: Chronic Kidney Disease; Hypertension

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03299816

IRB00122943

1U01MD010550-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Self-Shopping DASH group (S-DASH)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Shopping DASH group (S-DASH)

Coaching DASH group (C-DASH)

Experimental group

Description:

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.

Treatment:

Behavioral: Coaching DASH group (C-DASH)