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Five, Plus Nuts and Beans for Kidneys

Primary Purpose

Chronic Kidney Disease, Hypertension

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Coaching DASH group (C-DASH)

Self-Shopping DASH group (S-DASH)

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Hypertension, Albuminuria, African Americans

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

East Baltimore Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Self-Shopping DASH group (S-DASH)

Coaching DASH group (C-DASH)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Urinary Albumin Excretion From Baseline to 4 Months

Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Secondary Outcome Measures

Change in Systolic Blood Pressure From Baseline to 4 Months

Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

Change in Systolic Blood Pressure From Baseline to 12 Months

Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

Change in Urinary Albumin Excretion From Baseline to 12 Months

Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Full Information

NCT ID

NCT03299816

First Posted

September 18, 2017

Last Updated

May 30, 2023

Sponsor

Johns Hopkins University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT03299816

Brief Title

Five, Plus Nuts and Beans for Kidneys

Official Title

Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 22, 2018 (Actual)

Primary Completion Date

November 22, 2021 (Actual)

Study Completion Date

December 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Hypertension

Keywords

Chronic Kidney Disease, Hypertension, Albuminuria, African Americans

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single center, randomized controlled trial with two parallel arms.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-Shopping DASH group (S-DASH)

Arm Type

Active Comparator

Arm Description

Arm Title

Coaching DASH group (C-DASH)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Coaching DASH group (C-DASH)

Other Intervention Name(s)

Coaching DASH diet advice group (C-DASH)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Self-Shopping DASH group (S-DASH)

Other Intervention Name(s)

Self-Shopping DASH diet advice Group (S-DASH)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Urinary Albumin Excretion From Baseline to 4 Months

Description

Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Time Frame

Baseline, 4 months

Secondary Outcome Measure Information:

Title

Change in Systolic Blood Pressure From Baseline to 4 Months

Description

Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

Time Frame

Baseline,4 months

Title

Change in Systolic Blood Pressure From Baseline to 12 Months

Description

Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

Time Frame

Baseline, end of study (approximately 12 months)

Title

Change in Urinary Albumin Excretion From Baseline to 12 Months

Description

Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Time Frame

Baseline, end of study (approximately 12 months)

Other Pre-specified Outcome Measures:

Title

Change in Urinary Albumin Excretion From Baseline to 1 Month

Description

Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Time Frame

Baseline, 1 month

Title

Change in Systolic Blood Pressure From Baseline to 1 Month

Description

Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

Time Frame

Baseline, 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deidra Crews, MD, ScM

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

East Baltimore Medical Campus

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Five, Plus Nuts and Beans for Kidneys

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