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/NCT06019624</url>
    </required_header>
    <id_info>
      <org_study_id>2023-14791</org_study_id>
      <nct_id>NCT06019624</nct_id>
    </id_info>
    <brief_title>Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes</brief_title>
    <official_title>Fresh Takes!: An Evaluation of the Impact of Receiving Fresh Food Boxes on Dietary Intake, Food Insecurity, and Diabetic Control for Individuals With Diabetes or Prediabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Montefiore Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Department of Agriculture (USDA)</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Montefiore Medical Center</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>
        Fresh Takes! is a targeted food distribution and nutrition education program offered by&#xD;
        Montefiore Bronx Health Collective, a Federally Qualified Health Center located in the South&#xD;
        Bronx. The goal of Fresh Takes! is to help reduce food insecurity and prevent progressions to&#xD;
        overt diabetes in patients with prediabetes and to help patients with overt diabetes achieve&#xD;
        better diabetic control. To that end, participants receive bimonthly fresh food boxes and&#xD;
        nutritional support and education over the course of a six-month program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Diabetes affects approximately one in 10 individuals in the United States and is associated&#xD;
        with cardiovascular disease, nerve and retinal damage, and kidney disease. In 2019, it was&#xD;
        reported to be the 7th leading cause of death nationally. Unfortunately, diabetes&#xD;
        disproportionally affects people of color, those of heavier weight, and those with lower&#xD;
        incomes. All of these characteristics are common in residents of the communities served by&#xD;
        Montefiore Bronx Health Collective (BHC). Enrolling patients in care at BHC with prediabetes&#xD;
        or overt diabetes into Fresh Takes! has the potential to improve short term outcomes and&#xD;
        reduce the risk of developing diabetes-associated comorbidities for a highly vulnerable&#xD;
        population. The 6-month program has three major components: 1) receipt of a fresh food box&#xD;
        twice each month, 2) group nutrition education provided at the time of bimonthly food pickup,&#xD;
        and 3) individualized support by a dietician. One of the unique aspects of Fresh Takes! is&#xD;
        the provision of a fresh food box to participants. Healthier dietary patterns have been found&#xD;
        to be associated with significantly lower risk of developing diabetes and better glycemic&#xD;
        control among individuals with diabetes. Yet, little research to date has been conducted on&#xD;
        the impact of providing fresh fruits and vegetables on diabetic control for individuals with&#xD;
        diabetes or prediabetes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in HbA1c levels</measure>
      <time_frame>From baseline up to 12 months after program completion, up to 18 months total</time_frame>
      <description>Change in HbA1C levels will be evaluated from preintervention to postintervention. Participants' baseline HbA1c values will be abstracted from medical records. The HbA1c value obtained during clinical care closest to the time of enrollment will serve as the baseline value. The HBA1C reading obtained during clinical care closest to the end date of the program will be used as the follow up measure. Elevated HbA1c levels are a significant risk factor in many disease conditions. Better glycemic control leads to more favorable outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Food Security</measure>
      <time_frame>From baseline up to 12 months after program completion, up to 18 months total</time_frame>
      <description>Change in food security from preintervention to postintervention as measured by the USDA Six-item Short Form of the Food Security Survey. Participant responses are coded as described on the short form and the sum of affirmative responses to the six questions in the module represents the raw score on the scale with a possible scoring range of 0-6 with higher scores being indicative of greater food insecurity. Specifically, an overall score from 0-1 represents high food security; an overall score from 2-4 represents low food security; and an overall score from 5-6 represents very low food security.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Fruit and Vegetable Intake</measure>
      <time_frame>6 months</time_frame>
      <description>Change in fruit and vegetable intake form pre- to post-intervention as measured by Fruit and Vegetable module of the Dietary Screener Questionnaire (DSQ-FV). The DSQ-FV consists of 10 questions that queries participants regarding their intake of fruits and vegetables. Responses to the questions are converted to an estimated daily average per participant. Higher fruit and vegetable intake is associated with better glycemic control and better overall health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of diabetes-related primary health care visits</measure>
      <time_frame>Up to 12 months after program completion, up to 18 months total</time_frame>
      <description>The number of diabetes-related primary health care visits will be recorded to determine if individuals enrolled in Fresh Takes! have fewer excess visits related to diabetes pre- as compared to post-intervention. Diabetes-related visits will be determined from the electronic medical record (EMR) Diabetes-related visits will be pulled from the Electronic Medical Record (EMR) and defined as visits that have an associated ICD code indicating care for diabetes in the 6 months prior to enrollment. Excess care for this study is defined as having more than one visit for diabetes care in a 6-month period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Emergency Room Utilization</measure>
      <time_frame>From baseline up to 12 months after program completion, up to 18 months total</time_frame>
      <description>Change in emergency room (ER) utilization will be assessed by the number of emergency room visits to determine if individuals enrolled in Fresh Takes! have fewer emergency room visits related to diabetes pre- as compared to post-intervention. Changes in ER use will be analyzed based on surveys and number of ER visits pulled from the EMR for the 6 months prior to enrollment in Fresh Takes! compared to the number of ER visits for participants in the 6 months following program completion.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Diabetes</condition>
    <condition>PreDiabetes</condition>
    <condition>Food Insecurity</condition>
    <arm_group>
      <arm_group_label>Cohort 1 Receipt of Food Box</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 Receipt of Food Box</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3 Receipt of Food Box</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4 Receipt of Food Box</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Fresh Takes!</intervention_name>
      <description>Receipt of a fresh produce box, nutritional education and support in a 6 month program</description>
      <arm_group_label>Cohort 1 Receipt of Food Box</arm_group_label>
      <arm_group_label>Cohort 2 Receipt of Food Box</arm_group_label>
      <arm_group_label>Cohort 3 Receipt of Food Box</arm_group_label>
      <arm_group_label>Cohort 4 Receipt of Food Box</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-75 years of age&#xD;
  &#xD;
            -  Be a patient of BHC&#xD;
  &#xD;
            -  Experienced food insecurity in the previous year&#xD;
  &#xD;
          Identified as:&#xD;
  &#xD;
            1. having diabetes based on an ICD diagnosis code in the Electronic Medical Record (EMR)&#xD;
               or having a less than ideal HbA1c level, defined as &gt;6.4% within the preceding 12&#xD;
               months OR&#xD;
  &#xD;
            2. having prediabetes based on an ICD diagnosis code in the EMR or by having a HbA1c&#xD;
               level between 5.7% - 6.4% in the preceding 12 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Barbara Hackley, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Montefiore Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rubayat Qadeer, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Montefiore Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Barbara Hackley, PhD</last_name>
      <phone>2032603599</phone>
      <email>bhackley@montefiore.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fadhylla Saballos, MPH</last_name>
      <phone>7189910605</phone>
      <email>fsaballo@montefiore.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Montefiore Bronx Health Collective</name>
        <address>
          <city>Bronx</city>
          <state>New York</state>
          <zip>10459</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Barbara Hackley, PHD</last_name>
        <phone>203-260-3599</phone>
        <email>bhackley@montefiore.org</email>
      </contact>
      <contact_backup>
        <last_name>Fadhylla fsaballo@montefiore.org, MPH</last_name>
        <phone>7189910605</phone>
        <email>fsaballo@montefiore.org</email>
      </contact_backup>
      <investigator>
        <last_name>Fadhylla Saballos, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rubayat Qadeer, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Barbara Hackley, PHD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabetes</keyword>
    <keyword>PreDiabetes</keyword>
    <keyword>Food Insecurity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
      <mesh_term>Glucose Intolerance</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No data to be shared with other researchers</ipd_description>
    </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/NCT06019624
  org study id: 2023-14791
  nct id: NCT06019624
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Fresh Takes! is a targeted food distribution and nutrition education program offered by
        Montefiore Bronx Health Collective, a Federally Qualified Health Center located in the South
        Bronx. The goal of Fresh Takes! is to help reduce food insecurity and prevent progressions to
        overt diabetes in patients with prediabetes and to help patients with overt diabetes achieve
        better diabetic control. To that end, participants receive bimonthly fresh food boxes and
        nutritional support and education over the course of a six-month program.
  Diabetes affects approximately one in 10 individuals in the United States and is associated
        with cardiovascular disease, nerve and retinal damage, and kidney disease. In 2019, it was
        reported to be the 7th leading cause of death nationally. Unfortunately, diabetes
        disproportionally affects people of color, those of heavier weight, and those with lower
        incomes. All of these characteristics are common in residents of the communities served by
        Montefiore Bronx Health Collective (BHC). Enrolling patients in care at BHC with prediabetes
        or overt diabetes into Fresh Takes! has the potential to improve short term outcomes and
        reduce the risk of developing diabetes-associated comorbidities for a highly vulnerable
        population. The 6-month program has three major components: 1) receipt of a fresh food box
        twice each month, 2) group nutrition education provided at the time of bimonthly food pickup,
        and 3) individualized support by a dietician. One of the unique aspects of Fresh Takes! is
        the provision of a fresh food box to participants. Healthier dietary patterns have been found
        to be associated with significantly lower risk of developing diabetes and better glycemic
        control among individuals with diabetes. Yet, little research to date has been conducted on
        the impact of providing fresh fruits and vegetables on diabetic control for individuals with
        diabetes or prediabetes.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in HbA1c levels
  time frame: From baseline up to 12 months after program completion, up to 18 months total
  description: Change in HbA1C levels will be evaluated from preintervention to postintervention. Participants' baseline HbA1c values will be abstracted from medical records. The HbA1c value obtained during clinical care closest to the time of enrollment will serve as the baseline value. The HBA1C reading obtained during clinical care closest to the end date of the program will be used as the follow up measure. Elevated HbA1c levels are a significant risk factor in many disease conditions. Better glycemic control leads to more favorable outcomes.
  measure: Change in Food Security
  time frame: From baseline up to 12 months after program completion, up to 18 months total
  description: Change in food security from preintervention to postintervention as measured by the USDA Six-item Short Form of the Food Security Survey. Participant responses are coded as described on the short form and the sum of affirmative responses to the six questions in the module represents the raw score on the scale with a possible scoring range of 0-6 with higher scores being indicative of greater food insecurity. Specifically, an overall score from 0-1 represents high food security; an overall score from 2-4 represents low food security; and an overall score from 5-6 represents very low food security.
  measure: Change in Fruit and Vegetable Intake
  time frame: 6 months
  description: Change in fruit and vegetable intake form pre- to post-intervention as measured by Fruit and Vegetable module of the Dietary Screener Questionnaire (DSQ-FV). The DSQ-FV consists of 10 questions that queries participants regarding their intake of fruits and vegetables. Responses to the questions are converted to an estimated daily average per participant. Higher fruit and vegetable intake is associated with better glycemic control and better overall health.
  measure: Number of diabetes-related primary health care visits
  time frame: Up to 12 months after program completion, up to 18 months total
  description: The number of diabetes-related primary health care visits will be recorded to determine if individuals enrolled in Fresh Takes! have fewer excess visits related to diabetes pre- as compared to post-intervention. Diabetes-related visits will be determined from the electronic medical record (EMR) Diabetes-related visits will be pulled from the Electronic Medical Record (EMR) and defined as visits that have an associated ICD code indicating care for diabetes in the 6 months prior to enrollment. Excess care for this study is defined as having more than one visit for diabetes care in a 6-month period.
  measure: Change in Emergency Room Utilization
  time frame: From baseline up to 12 months after program completion, up to 18 months total
  description: Change in emergency room (ER) utilization will be assessed by the number of emergency room visits to determine if individuals enrolled in Fresh Takes! have fewer emergency room visits related to diabetes pre- as compared to post-intervention. Changes in ER use will be analyzed based on surveys and number of ER visits pulled from the EMR for the 6 months prior to enrollment in Fresh Takes! compared to the number of ER visits for participants in the 6 months following program completion.
  arm group label: Cohort 1 Receipt of Food Box
  arm group type: Active Comparator
  description: Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  arm group label: Cohort 2 Receipt of Food Box
  arm group type: Active Comparator
  description: Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  arm group label: Cohort 3 Receipt of Food Box
  arm group type: Active Comparator
  description: Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  arm group label: Cohort 4 Receipt of Food Box
  arm group type: Active Comparator
  description: Up to 80 individuals with diabetes or prediabetes with a history of food insecurity enrolled in a 6 month program offering free bimonthly fresh food boxes, nutrition education, and individualized support. Each enrolled individual will serve as their own control. The study will evaluate pre and post program changes in reported self-obtained home glucose levels, food security, and dietary intake.
  intervention type: Behavioral
  intervention name: Fresh Takes!
  description: Receipt of a fresh produce box, nutritional education and support in a 6 month program
  arm group label: Cohort 1 Receipt of Food Box
  arm group label: Cohort 2 Receipt of Food Box
  arm group label: Cohort 3 Receipt of Food Box
  arm group label: Cohort 4 Receipt of Food Box
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Barbara Hackley, PhD
  role: Study Director
  affiliation: Montefiore Medical Center
  last name: Rubayat Qadeer, MD
  role: Principal Investigator
  affiliation: Montefiore Medical Center
  last name: Barbara Hackley, PhD
  phone: 2032603599
  email: bhackley@montefiore.org
  last name: Fadhylla Saballos, MPH
  phone: 7189910605
  email: fsaballo@montefiore.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prediabetic State
  mesh term: Glucose Intolerance
  sharing ipd: No
  ipd description: No data to be shared with other researchers