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Five, Plus Nuts and Beans for Kidneys

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ClinicalTrials.gov Identifier: NCT03299816
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : July 17, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hypertension Behavioral: Coaching DASH group (C-DASH) Behavioral: Self-Shopping DASH group (S-DASH) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, randomized controlled trial with two parallel arms.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Coaching DASH diet advice group (C-DASH)




Primary Outcome Measures :
  1. Change in Albuminuria from Baseline to 1 month [ Time Frame: Baseline, 1 month ]
    Urine samples will be collected for ACR (albumin-to-creatinine ratio). Albuminuria is defined as an ACR ≥30 mg/g.

  2. Change in Albuminuria from Baseline to 4 months [ Time Frame: Baseline, 4 months ]
    Urine samples will be collected for ACR (albumin-to-creatinine ratio). Albuminuria is defined as an ACR ≥30 mg/g.

  3. Change in Albuminuria from Baseline to end of study [ Time Frame: Baseline, end of study (approximately 12 months) ]
    Urine samples will be collected for ACR (albumin-to-creatinine ratio). Albuminuria is defined as an ACR ≥30 mg/g.


Secondary Outcome Measures :
  1. Change in Systolic Blood Pressure [ Time Frame: Baseline, 1 month ]
    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

  2. Change in Systolic Blood Pressure [ Time Frame: Baseline,4 months ]
    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

  3. Change in Systolic Blood Pressure [ Time Frame: Baseline, end of study (approximately 12 months) ]
    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299816


Contacts
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Contact: Chiazam Omenyi, BS 410-614-4137 comenyi1@jhmi.edu

Locations
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United States, Maryland
East Baltimore Medical Campus Recruiting
Baltimore, Maryland, United States, 21202
Contact: Chiazam Omenyi, BS    410-614-4137    comenyi1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Deidra Crews, MD, ScM Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03299816    
Other Study ID Numbers: IRB00122943
1U01MD010550-01 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share the Statistical Analysis Plan and Study Protocol.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Chronic Kidney Disease
Hypertension
Albuminuria
African Americans
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency