xml: <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/NCT06033664</url>
    </required_header>
    <id_info>
      <org_study_id>88696</org_study_id>
      <nct_id>NCT06033664</nct_id>
    </id_info>
    <brief_title>Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes</brief_title>
    <official_title>Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alison Gustafson</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Instacart Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Kentucky Association of Health Plans</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Kentucky</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to evaluate the effectiveness of a grocery prescription program&#xD;
        in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will&#xD;
        enroll in Instacart Fresh Funds program. Once enrolled each week participants will select&#xD;
        foods that are eligible in the Fresh Funds Program to be delivered to their home for 12&#xD;
        weeks. Participants will also participate in a survey at the beginning of the study and at&#xD;
        the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)</measure>
      <time_frame>baseline and post intervention, approximately 12 weeks</time_frame>
      <description>HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in blood pressure</measure>
      <time_frame>baseline and post intervention, approximately 12 weeks</time_frame>
      <description>Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in food insecurity</measure>
      <time_frame>baseline and post intervention, approximately 12 weeks</time_frame>
      <description>The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Type 2 Diabetes Mellitus</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Grocery Prescription Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive the Fresh Funds through Instacart</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Fresh Funds</intervention_name>
      <description>Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.</description>
      <arm_group_label>Grocery Prescription Program</arm_group_label>
      <other_name>Grocery Prescription Program; Food As Medicine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Type 2 Diabetes Mellitus, hemoglobin A1c = 7.0% and = 12.0% in last 12&#xD;
               months, or diagnosis of hypertension&#xD;
  &#xD;
            -  Experiencing food insecurity as indicated by 2-item Hunger Vital Sign&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  No plans to move from the area for at least 1 year&#xD;
  &#xD;
            -  Willing and able to accept text messages&#xD;
  &#xD;
            -  Free living to the extent that participant has control over dietary intake&#xD;
  &#xD;
            -  Willing and able to provide written informed consent and participate in all study&#xD;
               activities.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant in diabetes, nutrition, or weight research intervention in last 12 months&#xD;
  &#xD;
            -  Another member of the household is already enrolled in this study&#xD;
  &#xD;
            -  Considering bariatric surgery in the next year or prior bariatric surgery&#xD;
  &#xD;
            -  Lack of safe, stable residence and ability to store meals&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alison Gustafson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alison Gustafson, PhD</last_name>
      <phone>859-257-1309</phone>
      <email>alison.gustafson@uky.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Kentucky</name>
        <address>
          <city>Lexington</city>
          <state>Kentucky</state>
          <zip>40506</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alison Gustafson, PhD</last_name>
        <phone>859-257-1309</phone>
        <email>alison.gustafson@uky.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Alison Gustafson</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Food Insecurity</keyword>
    <keyword>Food as Medicine</keyword>
    <keyword>Medicaid Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033664
  org study id: 88696
  nct id: NCT06033664
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the effectiveness of a grocery prescription program
        in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will
        enroll in Instacart Fresh Funds program. Once enrolled each week participants will select
        foods that are eligible in the Fresh Funds Program to be delivered to their home for 12
        weeks. Participants will also participate in a survey at the beginning of the study and at
        the end of the study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)
  time frame: baseline and post intervention, approximately 12 weeks
  description: HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.
  measure: Change in blood pressure
  time frame: baseline and post intervention, approximately 12 weeks
  description: Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart.
  measure: Change in food insecurity
  time frame: baseline and post intervention, approximately 12 weeks
  description: The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity.
  arm group label: Grocery Prescription Program
  arm group type: Experimental
  description: Participants will receive the Fresh Funds through Instacart
  intervention type: Behavioral
  intervention name: Fresh Funds
  description: Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.
  arm group label: Grocery Prescription Program
  other name: Grocery Prescription Program; Food As Medicine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Alison Gustafson, PhD
  role: Principal Investigator
  affiliation: University of Kentucky
  last name: Alison Gustafson, PhD
  phone: 859-257-1309
  email: alison.gustafson@uky.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Alison Gustafson
  investigator title: Professor
  mesh term: Hypertension
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2