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/NCT05979519</url>
    </required_header>
    <id_info>
      <org_study_id>86500</org_study_id>
      <nct_id>NCT05979519</nct_id>
    </id_info>
    <brief_title>Fresh Carts for Mom's to Improve Food Security and Glucose Management</brief_title>
    <official_title>Fresh Carts for Mom's to Improve Food Security and Glucose Management</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>
        This study will look at the benefit of decreasing food insecurity and improving glucose&#xD;
        control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type&#xD;
        2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery&#xD;
        prescription with delivery through Instacart at the start of the study or after 12 weeks or&#xD;
        frozen medically tailored meals delivered from Door Dash. Researchers will compare the&#xD;
        grocery prescription program, MTM (medically tailored meals), relative to standard of care to&#xD;
        see if the impact on these food as medicine programs can improve glucose control over&#xD;
        12-weeks as compared to standard of care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who&#xD;
        report food insecurity using the Hunger Vital Signs Screener will be recruited to participate&#xD;
        in a comparative study across two urban communities. One arm will receive a grocery&#xD;
        prescription program from Instacart Health to be spent on eligible healthy food items based&#xD;
        on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered&#xD;
        to their door each week. The meals are based on diabetes guidelines and are culturally&#xD;
        appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville,&#xD;
        Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be&#xD;
        recruited initially from a registered nurse who works at the clinic sites. The study team&#xD;
        will then enroll participants after eligibility screening and conduct further onboarding into&#xD;
        the food as medicine package based on locations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage Change in fasting blood glucose</measure>
      <time_frame>baseline and post intervention, approximately 12 weeks</time_frame>
      <description>Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.</description>
    </primary_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>
    <secondary_outcome>
      <measure>Change in self efficacy</measure>
      <time_frame>baseline and post intervention, approximately 12 weeks</time_frame>
      <description>The self efficacy scale for diabetes measures the confidence in managing diabetes. Scores range from 1 to 10 with a higher score indicating greater confidence in managing diabetes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood pressure</measure>
      <time_frame>baseline and post intervention, approximately 12 weeks</time_frame>
      <description>Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
    <condition>Type 2 Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Grocery Prescription Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Medical Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the delayed control group will receive their usual care through their healthcare provider and then participate in Fresh Funds or MTM after the initial 12-weeks of intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MTM (medically tailored frozen meals)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Fresh Funds for Mom's</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.&#xD;
  Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then 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>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard Medical care</intervention_name>
      <description>Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks or be provided the medically tailored meals for 12 weeks.</description>
      <arm_group_label>Standard Medical Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Medically Tailored Frozen Meals</intervention_name>
      <description>Participants will enroll in the MTM program. Once enrolled participants will receive 10 frozen meals delivered by Door Dash to their home each week for 12 weeks.</description>
      <arm_group_label>MTM (medically tailored frozen meals)</arm_group_label>
      <other_name>MTM; Food As Medicine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of gestational diabetes or type 2 diabetes&#xD;
  &#xD;
            -  answer affirmative to one of two questions on the Hunger Vital Signs&#xD;
  &#xD;
            -  viable pregnancy&#xD;
  &#xD;
            -  lives in a service area of Instacart delivery&#xD;
  &#xD;
            -  has a phone or computer which allows ordering food for delivery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Does not speak English&#xD;
  &#xD;
            -  Does not have a phone, tablet, or computer to order groceries for Instacart&#xD;
  &#xD;
            -  Plans to move within the next 3 months&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 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>
      <facility>
        <name>U of L Health</name>
        <address>
          <city>Louisville</city>
          <state>Kentucky</state>
          <zip>40202</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lauren Sells</last_name>
        <phone>502-588-4720</phone>
        <email>lauren.sells@uoflhealth.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 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>Pregnancy</keyword>
    <keyword>Food Insecurity</keyword>
    <keyword>Food As Medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes, Gestational</mesh_term>
      <mesh_term>Pregnancy in Diabetics</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05979519
  org study id: 86500
  nct id: NCT05979519
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will look at the benefit of decreasing food insecurity and improving glucose
        control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type
        2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery
        prescription with delivery through Instacart at the start of the study or after 12 weeks or
        frozen medically tailored meals delivered from Door Dash. Researchers will compare the
        grocery prescription program, MTM (medically tailored meals), relative to standard of care to
        see if the impact on these food as medicine programs can improve glucose control over
        12-weeks as compared to standard of care.
  Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who
        report food insecurity using the Hunger Vital Signs Screener will be recruited to participate
        in a comparative study across two urban communities. One arm will receive a grocery
        prescription program from Instacart Health to be spent on eligible healthy food items based
        on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered
        to their door each week. The meals are based on diabetes guidelines and are culturally
        appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville,
        Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be
        recruited initially from a registered nurse who works at the clinic sites. The study team
        will then enroll participants after eligibility screening and conduct further onboarding into
        the food as medicine package based on locations.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Percentage Change in fasting blood glucose
  time frame: baseline and post intervention, approximately 12 weeks
  description: Fasting blood glucose obtained baseline and post intervention (prior to delivery) 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.
  measure: Change in self efficacy
  time frame: baseline and post intervention, approximately 12 weeks
  description: The self efficacy scale for diabetes measures the confidence in managing diabetes. Scores range from 1 to 10 with a higher score indicating greater confidence in managing diabetes.
  measure: Change in blood pressure
  time frame: baseline and post intervention, approximately 12 weeks
  description: Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
  arm group label: Grocery Prescription Program
  arm group type: Experimental
  description: Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
  arm group label: Standard Medical Care
  arm group type: Active Comparator
  description: the delayed control group will receive their usual care through their healthcare provider and then participate in Fresh Funds or MTM after the initial 12-weeks of intervention.
  arm group label: MTM (medically tailored frozen meals)
  arm group type: Experimental
  description: Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
  intervention type: Behavioral
  intervention name: Fresh Funds for Mom's
  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.
  Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then 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
  intervention type: Behavioral
  intervention name: Standard Medical care
  description: Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks or be provided the medically tailored meals for 12 weeks.
  arm group label: Standard Medical Care
  intervention type: Behavioral
  intervention name: Medically Tailored Frozen Meals
  description: Participants will enroll in the MTM program. Once enrolled participants will receive 10 frozen meals delivered by Door Dash to their home each week for 12 weeks.
  arm group label: MTM (medically tailored frozen meals)
  other name: MTM; Food As Medicine
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 55 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: 
  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: Diabetes, Gestational
  mesh term: Pregnancy in Diabetics
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No