Five, Plus Nuts and Beans for Kidneys

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Disease
• Intervention / Treatment: Behavioral: Self-Shopping DASH group (S-DASH); Behavioral: Coaching DASH group (C-DASH)

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • East Baltimore Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Self-Shopping DASH group (S-DASH); Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.; Other Names: Self-Shopping DASH diet advice Group (S-DASH)
Experimental: 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.	Behavioral: Coaching DASH group (C-DASH); Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.; Other Names: Coaching DASH diet advice group (C-DASH)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Urinary Albumin Excretion From Baseline to 1 Month	Urine samples will be collected for ACR (albumin-to-creatinine ratio).	Baseline, 1 month
Change in Systolic Blood Pressure From Baseline to 1 Month	Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl	Baseline, 1 month

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Deidra Crews, MD, ScM, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): November 22, 2021
• Study Completion (Actual): December 8, 2021

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Chronic Kidney Disease; African Americans; Albuminuria
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRB00122943; 1U01MD010550-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share the Statistical Analysis Plan and Study Protocol.
• IPD Sharing Time Frame: Data will be available after one year after final data collection.
• IPD Sharing Access Criteria: Will release de-identified information per request via Johns Hopkins agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No