Five, Plus Nuts and Beans for Kidneys
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 100 |
| Updated: | 8/29/2018 |
| Start Date: | December 4, 2017 |
| End Date: | September 22, 2021 |
| Contact: | Jasmine Mensah, BA |
| Email: | jmensah2@jhmi.edu |
| Phone: | 410-614-4137 |
Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease
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.
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.
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.
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.
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%), or use of insulin.
- Patients with a serum potassium >4.6 milliequivalent (mEq) /L45
- Urine ACR ≥ 1,000 mg/g
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