<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/NCT01689844</url>
  </required_header>
  <id_info>
    <org_study_id>NA00051935</org_study_id>
    <secondary_id>P50CA148087-01</secondary_id>
    <nct_id>NCT01689844</nct_id>
  </id_info>
  <brief_title>Randomized Trial of Tailored Dietary Advice to Lower Blood Pressure</brief_title>
  <acronym>FivePlus</acronym>
  <official_title>Five Plus Nuts and Beans Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Five Plus Nuts &amp; Beans Study is a randomized, controlled trial to compare two strategies&#xD;
      for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into&#xD;
      practice for 120 African American participants who are on stable doses of antihypertensive&#xD;
      medications. The first arm of our study offers minimal DASH-oriented dietary advice along&#xD;
      with a food credit at a local supermarket where they make their own decision of what to eat.&#xD;
      The second arm consists of a single one-hour session with a nutrition expert who provides&#xD;
      choices and places an on-line order from a community grocery store (Santoni's Market) with&#xD;
      targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in&#xD;
      blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine&#xD;
      potassium excretion, and self-report consumption of fruits and vegetables during the same&#xD;
      period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unhealthy diets have many social determinants; however, there is a markedly lower&#xD;
      availability of components of the DASH diet-recommended foods (such as fresh fruits and&#xD;
      vegetables, skim milk and whole grain foods) in predominantly African-American and&#xD;
      lower-income neighborhoods compared with Caucasian and higher-income neighborhoods. Unhealthy&#xD;
      dietary consumption patterns contribute, in part, to hypertension through deficiencies in&#xD;
      potassium, magnesium and vitamin C - all micronutrients with independent blood&#xD;
      pressure-lowering effects. Furthermore, use of thiazide-based antihypertensive therapy often&#xD;
      worsens deficiencies through increased urinary excretion. Strategies that take into account&#xD;
      the multi-level nature of the problem of poor nutrition among low income African Americans&#xD;
      are needed to improve adherence to dietary recommendations and reverse micronutrient&#xD;
      deficiencies in hypertensive adults. The Five Plus Nuts &amp; Beans Study is a randomized,&#xD;
      controlled trial to compare two strategies for translating the results of the DASH (Dietary&#xD;
      Approaches to Stop Hypertension) Study into practice for 120 African American participants&#xD;
      who are on stable doses of antihypertensive medications. The first arm of our study offers&#xD;
      minimal DASH-oriented dietary advice along with a food credit at a local supermarket where&#xD;
      they make their own decision of what to eat. The second arm consists of a single one-hour&#xD;
      session with a nutrition expert who provides choices and places an on-line order from a&#xD;
      community grocery store (Santoni's Market) with targeted purchases of fruits, vegetables,&#xD;
      nuts and beans. Following the initial contact, there is a weekly call with the coordinator&#xD;
      for a $30 per week food delivery. Food orders are delivered for pick-up weekly by&#xD;
      participants at a Baltimore Public Library in participant's neighborhood. Our primary outcome&#xD;
      is change in blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid,&#xD;
      urine potassium excretion, and self-report consumption of fruits and vegetables during the&#xD;
      same period. After completion of the active phase of the trial, we will follow blood&#xD;
      pressures in the electronic medical record for one year to assess long-term effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>8-wks follow-up</time_frame>
    <description>Daytime systolic blood pressure determined by OMRON 907-xl blood pressure monitoring, will be the primary outcome measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose, lipids and uric acid; urine K and Na excretion</measure>
    <time_frame>8-wks follow-up</time_frame>
    <description>Fasting blood collections will occur in the morning after an overnight fast.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>High Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Behavioral, DASH Plus - Dietary advice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive DASH diet advice and guided ordering of fruits, vegetables, nuts and beans that are high in potassium from a local supermarket.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DASH - C</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>DASH C Group will receive brief DASH diet advice and will be able to make non- guided purchases of food products from the local supermarket.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DASH Plus</intervention_name>
    <description>DASH diet advice and guided shopping for high postassium foods at a local supermarket</description>
    <arm_group_label>Behavioral, DASH Plus - Dietary advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DASH - C</intervention_name>
    <description>Brief DASH dietary advice, No shopping guidance at the local supermarket.</description>
    <arm_group_label>DASH - C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be age 21 or older,&#xD;
&#xD;
          -  have a diagnosis of hypertension or pre-hypertension&#xD;
&#xD;
          -  under regular care with their physician, and&#xD;
&#xD;
          -  compliant with medications.&#xD;
&#xD;
          -  systolic blood pressure of 120-140 mmHg and/or&#xD;
&#xD;
          -  a diastolic blood pressure of 80-90 mmHg (average of two visits)&#xD;
&#xD;
          -  on stable doses of antihypertensive medications for a minimum of two months prior to&#xD;
             randomization, (and for the duration of the study).&#xD;
&#xD;
          -  be able to follow all trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiovascular event within 6 months,&#xD;
&#xD;
          -  chronic disease that might interfere with trial participation (e.g. chronic kidney&#xD;
             disease (estimated GFR &lt; 60 cc/min),&#xD;
&#xD;
          -  unwillingness or inability to adopt a DASH-like diet, and&#xD;
&#xD;
          -  consumption of more than 14 alcoholic drinks per week,&#xD;
&#xD;
          -  poorly controlled diabetes (Hemoglobin A1c &gt;9%),&#xD;
&#xD;
          -  use of insulin,&#xD;
&#xD;
          -  use of mineral supplements or an unwillingness to stop supplements one month prior to&#xD;
             randomization and refrain from the supplements during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edgar R Miller III, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Community Physicians, East Baltimore Medical Center</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>August 2016</verification_date>
  <study_first_submitted>April 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>August 30, 2016</last_update_submitted>
  <last_update_submitted_qc>August 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Edgar R. Miller, III</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>controlled high blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01689844
org study id: NA00051935
secondary id: P50CA148087-01
nct id: NCT01689844
lead sponsor: 
collaborator: 
has dmc: Yes
The Five Plus Nuts & Beans Study is a randomized, controlled trial to compare two strategies
      for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into
      practice for 120 African American participants who are on stable doses of antihypertensive
      medications. The first arm of our study offers minimal DASH-oriented dietary advice along
      with a food credit at a local supermarket where they make their own decision of what to eat.
      The second arm consists of a single one-hour session with a nutrition expert who provides
      choices and places an on-line order from a community grocery store (Santoni's Market) with
      targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in
      blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine
      potassium excretion, and self-report consumption of fruits and vegetables during the same
      period.
Unhealthy diets have many social determinants; however, there is a markedly lower
      availability of components of the DASH diet-recommended foods (such as fresh fruits and
      vegetables, skim milk and whole grain foods) in predominantly African-American and
      lower-income neighborhoods compared with Caucasian and higher-income neighborhoods. Unhealthy
      dietary consumption patterns contribute, in part, to hypertension through deficiencies in
      potassium, magnesium and vitamin C - all micronutrients with independent blood
      pressure-lowering effects. Furthermore, use of thiazide-based antihypertensive therapy often
      worsens deficiencies through increased urinary excretion. Strategies that take into account
      the multi-level nature of the problem of poor nutrition among low income African Americans
      are needed to improve adherence to dietary recommendations and reverse micronutrient
      deficiencies in hypertensive adults. The Five Plus Nuts & Beans Study is a randomized,
      controlled trial to compare two strategies for translating the results of the DASH (Dietary
      Approaches to Stop Hypertension) Study into practice for 120 African American participants
      who are on stable doses of antihypertensive medications. The first arm of our study offers
      minimal DASH-oriented dietary advice along with a food credit at a local supermarket where
      they make their own decision of what to eat. The second arm consists of a single one-hour
      session with a nutrition expert who provides choices and places an on-line order from a
      community grocery store (Santoni's Market) with targeted purchases of fruits, vegetables,
      nuts and beans. Following the initial contact, there is a weekly call with the coordinator
      for a $30 per week food delivery. Food orders are delivered for pick-up weekly by
      participants at a Baltimore Public Library in participant's neighborhood. Our primary outcome
      is change in blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid,
      urine potassium excretion, and self-report consumption of fruits and vegetables during the
      same period. After completion of the active phase of the trial, we will follow blood
      pressures in the electronic medical record for one year to assess long-term effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Blood Pressure
time frame: 8-wks follow-up
description: Daytime systolic blood pressure determined by OMRON 907-xl blood pressure monitoring, will be the primary outcome measurement
measure: Fasting glucose, lipids and uric acid; urine K and Na excretion
time frame: 8-wks follow-up
description: Fasting blood collections will occur in the morning after an overnight fast.
arm group label: Behavioral, DASH Plus - Dietary advice
arm group type: Active Comparator
description: This group will receive DASH diet advice and guided ordering of fruits, vegetables, nuts and beans that are high in potassium from a local supermarket.
arm group label: DASH - C
arm group type: Other
description: DASH C Group will receive brief DASH diet advice and will be able to make non- guided purchases of food products from the local supermarket.
intervention type: Behavioral
intervention name: DASH Plus
description: DASH diet advice and guided shopping for high postassium foods at a local supermarket
arm group label: Behavioral, DASH Plus - Dietary advice
intervention type: Behavioral
intervention name: DASH - C
description: Brief DASH dietary advice, No shopping guidance at the local supermarket.
arm group label: DASH - C
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Edgar R Miller III, MD, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Edgar R. Miller, III
investigator title: Principal Investigator
mesh term: Hypertension