<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/NCT03832166</url>
  </required_header>
  <id_info>
    <org_study_id>1R21DK113440-01A1</org_study_id>
    <nct_id>NCT03832166</nct_id>
  </id_info>
  <brief_title>Reducing Chronic Kidney Disease Burden in an Underserved Population</brief_title>
  <official_title>A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&amp;V Intervention to Improve F&amp;V Intake and CKD Outcomes in 140 AA Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</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>
      To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene&#xD;
      with individuals at high risk of CKD progression to ESRD that could be implemented in other&#xD;
      high risk communities and health care systems. This novel study will evaluate the feasibility&#xD;
      and preliminary efficacy of providing F&amp;V to individuals identified at high risk study for&#xD;
      CKD and ESRD through community health screenings. Further, it will evaluate whether providing&#xD;
      education as to how to prepare F&amp;V for consumption, the latter being done for all F&amp;V&#xD;
      recipients in PI's preliminary published studies but its efficacy was not specifically&#xD;
      tested, increases F&amp;V intake and thereby reduces CKD progression risk as well as related&#xD;
      clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Fruits and Veggies for Health&quot; is a prospective, randomized two group study to evaluate a&#xD;
      community-engaged screening, identification, and F&amp;V intervention to improve CKD outcomes in&#xD;
      140 AA adults (greater than 18 years). Participants will be randomized to a 1) F&amp;V only (F&amp;V&#xD;
      Only), or 2) F&amp;V plus a nutrition/cooking program (F&amp;V + Cook).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">July 14, 2020</completion_date>
  <primary_completion_date type="Actual">June 13, 2020</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>Prospective, randomized two group study</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Primary surrogate marker of eGFR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Measure of renal damage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Track changes in fruit and vegetable intake via ASA24 food diary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in dietary fat intake at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Track changes in fat (g) intake via ASA24 food diary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in caloric intake at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Track changes in total caloric(kcal) intake via ASA24 food diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Blood glucose at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months</measure>
    <time_frame>Baseline; 6 weeks; 6 months</time_frame>
    <description>Measure body mass index(lb/inches squared) to assess CVD risk</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>CKD</condition>
  <condition>ESRD</condition>
  <arm_group>
    <arm_group_label>Fruits and Vegetables Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive a prescribed amount of free fruits and vegetables (F &amp; V) for 6 weeks through pick-up at a farm stand, or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&amp;V at farm stands for an additional 18 weeks with minimal contact</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fruits and Vegetables and Cook</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the prescribed amount of free F&amp;V, participants will receive 6 weekly, group nutrition and cooking education classes based on &quot;The Happy Kitchen&quot; curriculum. Participants will also receive free ingredients to complete the recipe from each weekly session at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fruits and Vegetables</intervention_name>
    <description>Fruits and vegetables delivery, once/week for 24 weeks</description>
    <arm_group_label>Fruits and Vegetables Only</arm_group_label>
    <arm_group_label>Fruits and Vegetables and Cook</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cooking</intervention_name>
    <description>Nutrition education and cooking instruction class, one class/week for 6 weeks</description>
    <arm_group_label>Fruits and Vegetables and Cook</arm_group_label>
    <other_name>The Happy Kitchen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate in 6 month F&amp;V study&#xD;
&#xD;
          -  Positive urine dipstick.&#xD;
&#xD;
          -  African American (self declared) race&#xD;
&#xD;
          -  Access to internet via personal computer or mobile device&#xD;
&#xD;
          -  Ability to read and write in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative urine dipstick&#xD;
&#xD;
          -  Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)&#xD;
&#xD;
          -  Have received or need kidney transplant&#xD;
&#xD;
          -  Pregnant or plan to become pregnant in the next 6 months&#xD;
&#xD;
          -  Baseline urine potassium &gt; 60 mEq/g creatinine&#xD;
&#xD;
          -  Nephrotic proteinuria demonstrated on urine ACR measurement&#xD;
&#xD;
          -  Lacking access to the internet via personal computer or mobile device&#xD;
&#xD;
          -  Unable to read or write in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald Wesson, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor RI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Carithers TC, Talegawkar SA, Rowser ML, Henry OR, Dubbert PM, Bogle ML, Taylor HA Jr, Tucker KL. Validity and calibration of food frequency questionnaires used with African-American adults in the Jackson Heart Study. J Am Diet Assoc. 2009 Jul;109(7):1184-1193. doi: 10.1016/j.jada.2009.04.005.</citation>
    <PMID>19559135</PMID>
  </reference>
  <reference>
    <citation>Subar AF. Developing dietary assessment tools. J Am Diet Assoc. 2004 May;104(5):769-70. doi: 10.1016/j.jada.2004.02.007. No abstract available.</citation>
    <PMID>15127062</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>November 25, 2020</last_update_submitted>
  <last_update_submitted_qc>November 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CKD</keyword>
  <keyword>Low Income</keyword>
  <keyword>Diet</keyword>
  <keyword>Fruits and Vegetables</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 mths of outcome publication</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03832166/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>October 17, 2022</submitted>
    <returned>November 9, 2022</returned>
  </pending_results>
  <!-- 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/NCT03832166
org study id: 1R21DK113440-01A1
nct id: NCT03832166
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene
      with individuals at high risk of CKD progression to ESRD that could be implemented in other
      high risk communities and health care systems. This novel study will evaluate the feasibility
      and preliminary efficacy of providing F&V to individuals identified at high risk study for
      CKD and ESRD through community health screenings. Further, it will evaluate whether providing
      education as to how to prepare F&V for consumption, the latter being done for all F&V
      recipients in PI's preliminary published studies but its efficacy was not specifically
      tested, increases F&V intake and thereby reduces CKD progression risk as well as related
      clinical outcomes.
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a
      community-engaged screening, identification, and F&V intervention to improve CKD outcomes in
      140 AA adults (greater than 18 years). Participants will be randomized to a 1) F&V only (F&V
      Only), or 2) F&V plus a nutrition/cooking program (F&V + Cook).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized two group study
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Primary surrogate marker of eGFR
measure: Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Measure of renal damage
measure: Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Track changes in fruit and vegetable intake via ASA24 food diary
measure: Changes from baseline in dietary fat intake at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Track changes in fat (g) intake via ASA24 food diary
measure: Changes from baseline in caloric intake at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Track changes in total caloric(kcal) intake via ASA24 food diary
measure: Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)
measure: Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk
measure: Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk
measure: Changes from baseline in Blood glucose at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk
measure: Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
time frame: Baseline; 6 weeks; 6 months
description: Measure body mass index(lb/inches squared) to assess CVD risk
arm group label: Fruits and Vegetables Only
arm group type: Experimental
description: This group will receive a prescribed amount of free fruits and vegetables (F & V) for 6 weeks through pick-up at a farm stand, or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 18 weeks with minimal contact
arm group label: Fruits and Vegetables and Cook
arm group type: Experimental
description: In addition to the prescribed amount of free F&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum. Participants will also receive free ingredients to complete the recipe from each weekly session at home.
intervention type: Other
intervention name: Fruits and Vegetables
description: Fruits and vegetables delivery, once/week for 24 weeks
arm group label: Fruits and Vegetables Only
arm group label: Fruits and Vegetables and Cook
intervention type: Other
intervention name: Cooking
description: Nutrition education and cooking instruction class, one class/week for 6 weeks
arm group label: Fruits and Vegetables and Cook
other name: The Happy Kitchen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Donald Wesson, MD, MBA
role: Principal Investigator
affiliation: Baylor RI
facility: 
country: United States
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citation: Deci EL, Eghrari H, Patrick BC, Leone DR. Facilitating internalization: the self-determination theory perspective. J Pers. 1994 Mar;62(1):119-42. doi: 10.1111/j.1467-6494.1994.tb00797.x.
PMID: 8169757
citation: Carithers TC, Talegawkar SA, Rowser ML, Henry OR, Dubbert PM, Bogle ML, Taylor HA Jr, Tucker KL. Validity and calibration of food frequency questionnaires used with African-American adults in the Jackson Heart Study. J Am Diet Assoc. 2009 Jul;109(7):1184-1193. doi: 10.1016/j.jada.2009.04.005.
PMID: 19559135
citation: Subar AF. Developing dietary assessment tools. J Am Diet Assoc. 2004 May;104(5):769-70. doi: 10.1016/j.jada.2004.02.007. No abstract available.
PMID: 15127062
responsible party type: Sponsor
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 mths of outcome publication
provided document: 
submitted: October 17, 2022
returned: November 9, 2022