Five, Plus Nuts and Beans for Kidneys

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299816
• Other study ID #: IRB00122943
• Secondary ID: 1U01MD010550-01
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: December 8, 2021

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 8, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	East Baltimore Medical Campus	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Urinary Albumin Excretion From Baseline to 1 Month	Urine samples will be collected for ACR (albumin-to-creatinine ratio).	Baseline, 1 month
Other	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
Primary	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	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
Secondary	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)
Secondary	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)