<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299816</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00122943</org_study_id>
    <secondary_id>1U01MD010550-01</secondary_id>
    <nct_id>NCT03299816</nct_id>
  </id_info>
  <brief_title>Five, Plus Nuts and Beans for Kidneys</brief_title>
  <official_title>Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled&#xD;
      trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to&#xD;
      adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of&#xD;
      fruits, vegetables, nuts and beans tailored to personal choices and availability in&#xD;
      neighborhood stores, will reduce kidney damage in African Americans with hypertension and&#xD;
      chronic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will test the effectiveness of dietary advice delivered by a study coach and&#xD;
      assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by&#xD;
      a local grocer to a community location for reducing urinary albumin excretion among African&#xD;
      Americans with hypertension and chronic kidney disease. Participants will be recruited from&#xD;
      primary care clinics in Baltimore, MD.&#xD;
&#xD;
      150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney&#xD;
      disease based on the presence of albuminuria will be randomly assigned to one of two arms for&#xD;
      12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will&#xD;
      consist of minimal guidance from the study team and a weekly allowance of $30 dollars to&#xD;
      purchase food and drinks of their choosing from a local grocer. During Phase 1, the second&#xD;
      arm of the study will receive dietary guidance from the study coach and assistance with&#xD;
      ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In&#xD;
      Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm&#xD;
      will receive telephonic visits and dietary advice from the study coach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2018</start_date>
  <completion_date type="Actual">December 8, 2021</completion_date>
  <primary_completion_date type="Actual">November 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single center, randomized controlled trial with two parallel arms.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Urinary Albumin Excretion From Baseline to 4 Months</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure From Baseline to 4 Months</measure>
    <time_frame>Baseline,4 months</time_frame>
    <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure From Baseline to 12 Months</measure>
    <time_frame>Baseline, end of study (approximately 12 months)</time_frame>
    <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Urinary Albumin Excretion From Baseline to 12 Months</measure>
    <time_frame>Baseline, end of study (approximately 12 months)</time_frame>
    <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Urinary Albumin Excretion From Baseline to 1 Month</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Systolic Blood Pressure From Baseline to 1 Month</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Self-Shopping DASH group (S-DASH)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coaching DASH group (C-DASH)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coaching DASH group (C-DASH)</intervention_name>
    <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.</description>
    <arm_group_label>Coaching DASH group (C-DASH)</arm_group_label>
    <other_name>Coaching DASH diet advice group (C-DASH)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Shopping DASH group (S-DASH)</intervention_name>
    <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.</description>
    <arm_group_label>Self-Shopping DASH group (S-DASH)</arm_group_label>
    <other_name>Self-Shopping DASH diet advice Group (S-DASH)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified African American race&#xD;
&#xD;
          -  Age 21 years or older&#xD;
&#xD;
          -  Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of&#xD;
             ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59&#xD;
             ml/min/1.73m2.&#xD;
&#xD;
          -  Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or&#xD;
             Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months).&#xD;
&#xD;
          -  Must have a systolic blood pressure of &lt;=160 mmHg and a diastolic blood pressure of&#xD;
             &lt;=100 mmHg (average of two visits)&#xD;
&#xD;
          -  Be on stable doses of antihypertensive medications for a minimum of two months prior&#xD;
             to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular (CV) event within 6 months&#xD;
&#xD;
          -  Chronic disease that might interfere with trial participation (e.g. stage 4 or 5&#xD;
             Chronic Kidney Disease, Estimated Glomerular Filtration Rate &lt;30 ml/min/1.73m2)&#xD;
&#xD;
          -  Unwillingness or inability to adopt a DASH-like diet&#xD;
&#xD;
          -  Consumes over 14 alcoholic drinks per week&#xD;
&#xD;
          -  Poorly controlled diabetes (Hemoglobin A1c &gt;9%).&#xD;
&#xD;
          -  Patients with a serum potassium &gt;4.6 milliequivalent (mEq) /L45&#xD;
&#xD;
          -  Urine ACR ≥ 1,000 mg/g&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deidra Crews, MD, ScM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>East Baltimore Medical Campus</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>May 30, 2023</results_first_submitted>
  <results_first_submitted_qc>May 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2023</results_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Albuminuria</keyword>
  <keyword>African Americans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Plan to share the Statistical Analysis Plan and Study Protocol.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be available after one year after final data collection.</ipd_time_frame>
    <ipd_access_criteria>Will release de-identified information per request via Johns Hopkins agreement.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03299816/Prot_SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Coaching DASH Group (C-DASH)</title>
          <description>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.&#xD;
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.</description>
        </group>
        <group group_id="P2">
          <title>Self-Shopping DASH Group (S-DASH)</title>
          <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.&#xD;
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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase 1: 4-month Intervention Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 2: 12-month Follow-up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52">The number of eligible C-DASH participants included 53 who were randomized prior to 2021, minus 1 who dropped out during Phase 1. Seventeen C-DASH participants who were randomized in 2021 were invited to participate in Phase 1 only and were not included in Phase 2 of this study.</participants>
                <participants group_id="P2" count="56">The number of eligible S-DASH participants included 56 who were randomized prior to 2021. Sixteen S-DASH participants who were randomized in 2021 were invited to participate in Phase 1 only and were not included in Phase 2 of this study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Coaching DASH Group (C-DASH)</title>
          <description>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.&#xD;
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.</description>
        </group>
        <group group_id="B2">
          <title>Self-Shopping DASH Group (S-DASH)</title>
          <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.&#xD;
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.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="142"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.7" spread="13.7"/>
                    <measurement group_id="B2" value="62.7" spread="11.7"/>
                    <measurement group_id="B3" value="61.1" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Urinary albumin-to-creatine (ACR)</title>
          <units>mg/g</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="99.8" lower_limit="49.0" upper_limit="234.5"/>
                    <measurement group_id="B2" value="98.8" lower_limit="47.3" upper_limit="236.5"/>
                    <measurement group_id="B3" value="99.5" lower_limit="4.08" upper_limit="234.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128.1" spread="14.4"/>
                    <measurement group_id="B2" value="130.8" spread="12.8"/>
                    <measurement group_id="B3" value="129.4" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.3" spread="10.6"/>
                    <measurement group_id="B2" value="74.4" spread="11.2"/>
                    <measurement group_id="B3" value="73.3" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes (Self-report)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urinary albumin-to-creatine ratio category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;30 mg/g</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30 to &lt;300 mg/g</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=300 mg/g</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Urinary Albumin Excretion From Baseline to 4 Months</title>
        <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
        <time_frame>Baseline, 4 months</time_frame>
        <population>For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study and 2 were lost to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Coaching DASH Group (C-DASH)</title>
            <description>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.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Self-Shopping DASH Group (S-DASH)</title>
            <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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Urinary Albumin Excretion From Baseline to 4 Months</title>
          <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
          <population>For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study and 2 were lost to follow-up.</population>
          <units>mg/g</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.6" spread="12.0"/>
                    <measurement group_id="O2" value="-5.6" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt;0.05</p_value_desc>
            <method>Mixed effects regression</method>
            <method_desc>Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure From Baseline to 4 Months</title>
        <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
        <time_frame>Baseline,4 months</time_frame>
        <population>For C-DASH, 4 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 1 was due to measurement error. For S-DASH, 5 participants were excluded: 4 were due to measurement error, and 1 due to an out-of-range baseline reading.</population>
        <group_list>
          <group group_id="O1">
            <title>Coaching DASH Group (C-DASH)</title>
            <description>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.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Self-Shopping DASH Group (S-DASH)</title>
            <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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure From Baseline to 4 Months</title>
          <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
          <population>For C-DASH, 4 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 1 was due to measurement error. For S-DASH, 5 participants were excluded: 4 were due to measurement error, and 1 due to an out-of-range baseline reading.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="1.8"/>
                    <measurement group_id="O2" value="0.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.36</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt;0.05</p_value_desc>
            <method>Mixed effects regression</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure From Baseline to 12 Months</title>
        <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
        <time_frame>Baseline, end of study (approximately 12 months)</time_frame>
        <population>For C-DASH, 9 participants were excluded from analysis: 1 withdrew from Phase 2 of the study, 3 were lost to follow-up, 1 due to measurement error, 1 moved out of state, and 3 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 12 participants were excluded: 4 were lost to follow-up, 5 due to measurement error, and 3 were restricted from in-person data collection due to the pandemic.</population>
        <group_list>
          <group group_id="O1">
            <title>Coaching DASH Group (C-DASH)</title>
            <description>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.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Self-Shopping DASH Group (S-DASH)</title>
            <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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure From Baseline to 12 Months</title>
          <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
          <population>For C-DASH, 9 participants were excluded from analysis: 1 withdrew from Phase 2 of the study, 3 were lost to follow-up, 1 due to measurement error, 1 moved out of state, and 3 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 12 participants were excluded: 4 were lost to follow-up, 5 due to measurement error, and 3 were restricted from in-person data collection due to the pandemic.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="2.3"/>
                    <measurement group_id="O2" value="-1.6" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.33</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt;0.05</p_value_desc>
            <method>Mixed effects regression</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Urinary Albumin Excretion From Baseline to 12 Months</title>
        <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
        <time_frame>Baseline, end of study (approximately 12 months)</time_frame>
        <population>For C-DASH, 7 participants were excluded from analysis: 1 withdrew during Phase 2 of the study, 2 were lost to follow-up, and 4 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 8 participants were excluded: 3 were lost to follow-up, 1 sample was lost due to lab error, and 4 were restricted due to the pandemic.</population>
        <group_list>
          <group group_id="O1">
            <title>Coaching DASH Group (C-DASH)</title>
            <description>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.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Self-Shopping DASH Group (S-DASH)</title>
            <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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Urinary Albumin Excretion From Baseline to 12 Months</title>
          <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
          <population>For C-DASH, 7 participants were excluded from analysis: 1 withdrew during Phase 2 of the study, 2 were lost to follow-up, and 4 were restricted from providing in-person data collection due to the COVID-19 pandemic. For S-DASH, 8 participants were excluded: 3 were lost to follow-up, 1 sample was lost due to lab error, and 4 were restricted due to the pandemic.</population>
          <units>mg/g</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.5" spread="14.1"/>
                    <measurement group_id="O2" value="-1.4" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.61</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt;0.05</p_value_desc>
            <method>Mixed effects regression</method>
            <method_desc>Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Urinary Albumin Excretion From Baseline to 1 Month</title>
        <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
        <time_frame>Baseline, 1 month</time_frame>
        <population>For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study, and 2 were lost to follow-up. For S-DASH, 1 participant was excluded from analysis due to an invalid urine sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Coaching DASH Group (C-DASH)</title>
            <description>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.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Self-Shopping DASH Group (S-DASH)</title>
            <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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Urinary Albumin Excretion From Baseline to 1 Month</title>
          <description>Urine samples will be collected for ACR (albumin-to-creatinine ratio).</description>
          <population>For C-DASH, 3 participants were excluded from analysis: 1 withdrew from the study, and 2 were lost to follow-up. For S-DASH, 1 participant was excluded from analysis due to an invalid urine sample.</population>
          <units>mg/g</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.8" spread="10.1"/>
                    <measurement group_id="O2" value="-19.6" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.73</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt;0.05</p_value_desc>
            <method>Mixed effects regression</method>
            <method_desc>Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Systolic Blood Pressure From Baseline to 1 Month</title>
        <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
        <time_frame>Baseline, 1 month</time_frame>
        <population>For C-DASH, 7 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 4 were due to measurement error. For S-DASH, 4 participants were excluded: 3 were due to measurement error, and 1 due to an out-of-range at baseline reading.</population>
        <group_list>
          <group group_id="O1">
            <title>Coaching DASH Group (C-DASH)</title>
            <description>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.&#xD;
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.</description>
          </group>
          <group group_id="O2">
            <title>Self-Shopping DASH Group (S-DASH)</title>
            <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.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure From Baseline to 1 Month</title>
          <description>Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl</description>
          <population>For C-DASH, 7 participants were excluded from analysis: 1 withdrew from the study, 2 were lost to follow-up, and 4 were due to measurement error. For S-DASH, 4 participants were excluded: 3 were due to measurement error, and 1 due to an out-of-range at baseline reading.</population>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="1.6"/>
                    <measurement group_id="O2" value="-0.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.75</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt;0.05</p_value_desc>
            <method>Mixed effects regression</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The first 108 randomized participants: 1 year; The remaining 33 randomized participants: 4 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Coaching DASH Group (C-DASH)</title>
          <description>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.&#xD;
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.</description>
        </group>
        <group group_id="E2">
          <title>Self-Shopping DASH Group (S-DASH)</title>
          <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.&#xD;
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.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus with ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chest pain, unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Angioneurotic edema</sub_title>
                <description>due to lisinopril</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Motor Vehicle Accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Thrombotic microangiopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Mechanical complication of ventricular intracranial (communicating) shunt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney failure</sub_title>
                <description>possibly due to Lisinopril</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Moderate persistent asthma with (acute) exacerbation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac Catheterization</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction, unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm and dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Non-ST elevation myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Type 2 Subsequent non-ST elevation myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive Urgency</sub_title>
                <description>BP &gt;= 160/100</description>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <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.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Deidra C. Crews, MD, ScM</name_or_title>
      <organization>Johns Hopkins University School of Medicine</organization>
      <phone>410-502-0518</phone>
      <email>dcrews1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299816
org study id: IRB00122943
secondary id: 1U01MD010550-01
nct id: NCT03299816
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single center, randomized controlled trial with two parallel arms.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Urinary Albumin Excretion From Baseline to 4 Months
time frame: Baseline, 4 months
description: Urine samples will be collected for ACR (albumin-to-creatinine ratio).
measure: Change in Systolic Blood Pressure From Baseline to 4 Months
time frame: Baseline,4 months
description: Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
measure: Change in Systolic Blood Pressure From Baseline to 12 Months
time frame: Baseline, end of study (approximately 12 months)
description: Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
measure: Change in Urinary Albumin Excretion From Baseline to 12 Months
time frame: Baseline, end of study (approximately 12 months)
description: Urine samples will be collected for ACR (albumin-to-creatinine ratio).
measure: Change in Urinary Albumin Excretion From Baseline to 1 Month
time frame: Baseline, 1 month
description: Urine samples will be collected for ACR (albumin-to-creatinine ratio).
measure: Change in Systolic Blood Pressure From Baseline to 1 Month
time frame: Baseline, 1 month
description: Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl
arm group label: Self-Shopping DASH group (S-DASH)
arm group type: Active Comparator
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.
arm group label: Coaching DASH group (C-DASH)
arm group type: Experimental
description: 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 type: Behavioral
intervention name: Coaching DASH group (C-DASH)
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.
arm group label: Coaching DASH group (C-DASH)
other name: Coaching DASH diet advice group (C-DASH)
intervention type: Behavioral
intervention name: Self-Shopping DASH group (S-DASH)
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.
arm group label: Self-Shopping DASH group (S-DASH)
other name: Self-Shopping DASH diet advice Group (S-DASH)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: No
last name: Deidra Crews, MD, ScM
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Hypertension
sharing ipd: Yes
ipd description: Plan to share the Statistical Analysis Plan and Study Protocol.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be available after one year after final data collection.
ipd access criteria: Will release de-identified information per request via Johns Hopkins agreement.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
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.
point of contact: 