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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

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE October 3, 2017
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE February 22, 2018
Estimated Primary Completion Date September 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • Change in Systolic Blood Pressure [ Time Frame: Baseline, 1 month ]
    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
  • Change in Systolic Blood Pressure [ Time Frame: Baseline,4 months ]
    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Five, Plus Nuts and Beans for Kidneys
Official Title  ICMJE Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Chronic Kidney Disease
  • Hypertension
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Self-Shopping DASH 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.
    Intervention: Behavioral: Coaching DASH group (C-DASH)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 22, 2021
Estimated Primary Completion Date September 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chiazam Omenyi, BS 410-614-4137 comenyi1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03299816
Other Study ID Numbers  ICMJE IRB00122943
1U01MD010550-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Plan to share the Statistical Analysis Plan and Study Protocol.
Supporting Materials: Study Protocol
Supporting Materials: 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.
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Deidra Crews, MD, ScM Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP