Five, Plus Nuts and Beans for Kidneys

NCT03299816 | Completed Results DMC

• 2 other identifiers: IRB001229431U01MD010550-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Hypertension

Keywords

Chronic Kidney Disease; Hypertension; Albuminuria; African Americans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Systolic Blood Pressure From Baseline to 4 Months

  Baseline,4 months

• Change in Systolic Blood Pressure From Baseline to 12 Months

  Baseline, end of study (approximately 12 months)

• Change in Urinary Albumin Excretion From Baseline to 12 Months

  Baseline, end of study (approximately 12 months)

Other Outcomes (2)

• Change in Urinary Albumin Excretion From Baseline to 1 Month

  Baseline, 1 month

• Change in Systolic Blood Pressure From Baseline to 1 Month

  Baseline, 1 month

Study Arms (2)

Self-Shopping DASH group (S-DASH)

ACTIVE COMPARATOR

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)

Coaching DASH group (C-DASH)

EXPERIMENTAL

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)

Interventions

Coaching DASH group (C-DASH) BEHAVIORAL

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.

Also known as: Coaching DASH diet advice group (C-DASH)

Coaching DASH group (C-DASH)

Self-Shopping DASH group (S-DASH) BEHAVIORAL

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.

Also known as: Self-Shopping DASH diet advice Group (S-DASH)

Self-Shopping DASH group (S-DASH)

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

East Baltimore Medical Campus

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Albuminuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Limitations and Caveats

The COVID-19 pandemic restricted in-person research activities for \~6 months, which impacted trial conduct in two ways: (1) 8 of the participants randomized at the onset of the pandemic did not return when restrictions on in person research were lifted. They were excluded from the final sample size. (2) Upon resuming in-person activities, the protocol was modified to Phase 1 only for the 33 participants who were randomized in 2021, so that the trial could be completed within the funding period.

Results Point of Contact

• Title: Deidra C. Crews, MD, ScM
• Organization: Johns Hopkins University School of Medicine

dcrews1@jhmi.edu

410-502-0518

Study Officials

• Deidra Crews, MD, ScM

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, randomized controlled trial with two parallel arms.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 3, 2017
• Study Start: February 22, 2018
• Primary Completion: November 22, 2021
• Study Completion: December 8, 2021
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after one year after final data collection.
• Access Criteria: Will release de-identified information per request via Johns Hopkins agreement.

Locations

US (1)