<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/NCT04421755</url>
  </required_header>
  <id_info>
    <org_study_id>10360</org_study_id>
    <nct_id>NCT04421755</nct_id>
  </id_info>
  <brief_title>The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure</brief_title>
  <official_title>The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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>
      Hypertension and diabetes, which are increasing in prevalence, contribute to significant&#xD;
      morbidity and mortality in the U.S. Self-management of these diseases, including adherence to&#xD;
      dietary guidelines such as daily fruit and vegetable intake, can improve outcomes, but&#xD;
      low-income patients encounter many barriers to adherence, such as food insecurity and poor&#xD;
      nutrition literacy. Few clinicians screen for food insecurity, and even when screening is&#xD;
      performed, there are few tested clinical response models. This study will evaluate the&#xD;
      benefits of fresh fruit and vegetable home delivery program, without and with small-group&#xD;
      culinary medicine cooking classes, on blood pressure and glucose control among patients&#xD;
      accessing care at the University of Oklahoma Internal Medicine Clinic in Tulsa, OK. The&#xD;
      Produce Drop pilot study will evaluate the feasibility and potential health benefits of a&#xD;
      clinic-community partnership between OU Internal Medicine and a fresh produce home-delivery&#xD;
      service provider, to promote adherence to F/V dietary guidelines among patients with&#xD;
      suboptimal blood pressure and blood glucose control. Among half of those assigned to receive&#xD;
      food assistance, we will evaluate the additional benefits of participation in 3-session,&#xD;
      small-group, hands-on culinary medicine curriculum.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a diet rich in fruits and vegetables, is an essential requirement for optimal blood pressure&#xD;
      and glucose control. Clinical practice guidelines for hypertension and diabetes both assign&#xD;
      the highest grade of evidence for healthy eating behavior to treat these conditions.&#xD;
      Unfortunately, fewer than one-quarter of patients adhere to dietary recommendations, with the&#xD;
      largest disparities among lower socioeconomic groups and racial minorities. Patient adherence&#xD;
      to nutrition guidelines are deeply hindered by poor access to fresh produce and inadequate&#xD;
      knowledge about preparing medically-indicated foods. The proposed Produce Drop pilot study&#xD;
      will evaluate the feasibility and potential health benefits of a fresh fruit and vegetable&#xD;
      home-delivery program, with and without additional small-group culinary medicine cooking&#xD;
      classes, among low-income, Medicaid patients with suboptimal blood pressure and glucose&#xD;
      control. Patients (n=100) from OU-Tulsa Schusterman Internal Medicine Clinic will be&#xD;
      randomized to 1) a fresh fruit and vegetable home-delivery program, or 2) the same home&#xD;
      delivery program with supplementary small-group culinary medicine cooking classes. In&#xD;
      addition, we will include a third arm of control patients (n=50) who will receive the&#xD;
      standard of care. We will track blood pressure and glucose control in all three groups to&#xD;
      determine the comparative impact of each intervention. The proposed pilot study, informed by&#xD;
      the Institute for Healthcare Improvement's &quot;Triple Aim&quot; framework, will provide the formative&#xD;
      information needed to develop a larger-scale intervention to enhance the patient care&#xD;
      experience, improve population health status, and reduce the per capita cost of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2019</start_date>
  <completion_date type="Actual">March 16, 2021</completion_date>
  <primary_completion_date type="Actual">March 16, 2021</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>Factorial Assignment</intervention_model>
    <intervention_model_description>A randomized control trial will be used to evaluate the two interventions among a cohort of OU Internal Medicine patients. Clinical and self-report measures will be collected for the intervention arms at four time points: baseline, three months, six months, and nine months and at two time points (baseline and nine months) for the control group. After baseline measures, participants will be randomly assigned to the fruits and vegetables only group, the fruit and vegetables plus cooking classes group, or the control group. This trial will use rolling enrollment, with interventions beginning after the enrollment of enough participants to conduct an effective cooking class. Participants in the intervention groups will receive nine months of free weekly deliveries of fresh fruits and vegetables. Participants in the control group will receive a gift card valued at twenty dollars for each survey completed and an OU gift valued at ten dollars following completion of both surveys.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months</time_frame>
    <description>change scores in systolic blood pressure at each time point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months</time_frame>
    <description>change scores in diastolic blood pressure at each time point review include age, medications, insurance, A1c, systolic blood pressure, diastolic blood pressure, weight, height, tobacco use, emergency room use, and hospitalizations. Self-report survey items include demographics, insurance, diabetes/pre-diabetes diagnosis date, hypertension diagnosis date, health literacy, medication adherence and medication scrimping, smoking status (Adult Tobacco Survey), food security (USDA 6-item food security survey), grocery shopping; food access (NEMS-P), consumption of fruit and vegetables from weekly delivery , fruit and vegetable intake (f/v checklist), food preparation/eating at home/eating out behaviors, nutrition-related quality of life (NQOL), cooking knowledge, and cooking confidence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A1c</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months</time_frame>
    <description>change scores in A1C at each time point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food security</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months</time_frame>
    <description>change scores on a food security scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food environment</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>change scores on a food environment scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fruit and vegetable consumption</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>change scores on a fruit and vegetable consumption scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutrition knowledge</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>change scores on a fruit and vegetable consumption scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cooking skills</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>change scores on cooking skills scale</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <condition>Nutrition Poor</condition>
  <arm_group>
    <arm_group_label>Produce Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives weekly home delivery of fresh fruits and vegetables</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Produce + Cooking Classes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group with no cooking classes or groceries</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Produce delivery</intervention_name>
    <description>weekly home delivery of fresh fruits and vegetables</description>
    <arm_group_label>Produce + Cooking Classes</arm_group_label>
    <arm_group_label>Produce Only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cooking classes</intervention_name>
    <description>weekly home delivery of fresh fruits and vegetables participants will be invited to participate in a Culinary Medicine cooking series. The OU Culinary Medicine cooking curriculum will involve a 3-part class series designed to build nutrition knowledge and cooking self-efficacy for preparing fresh F/Vs. Each session is ~2 hr. Core nutrition guidelines for blood pressure and blood sugar management will also be emphasized informed by an evidence-based Conceptual Model of Healthy Cooking. Classes will be conducted in small groups (~16 participants) in an established teaching kitchen used by the culinary medicine program. Classes will be facilitated by a professional chef, a healthcare professional (dietitian, medical doctor, or trained medical student), and other support staff, including trained medical, dietetic, and public health students.</description>
    <arm_group_label>Produce + Cooking Classes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  English-speaking;&#xD;
&#xD;
          -  Between 18 - 64 years old;&#xD;
&#xD;
          -  Enrolled in Medicaid at baseline&#xD;
&#xD;
          -  Elevated blood pressure and/or A1C scores in the past three months&#xD;
&#xD;
          -  Access to regular medical care&#xD;
&#xD;
          -  Permission from physician to participate&#xD;
&#xD;
          -  Physical home address that can accept grocery deliveries&#xD;
&#xD;
          -  Lives inside the grocery service delivery area with no intention to move outside of&#xD;
             the service areas in the next 9 months&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Less than 18 years of age or over 64 years of age&#xD;
&#xD;
          -  Serious or terminal illness&#xD;
&#xD;
          -  Pregnant or planning to become pregnant in the next 9 months&#xD;
&#xD;
          -  Advanced end stage renal disease&#xD;
&#xD;
          -  Current enrollment in any other research studies on high blood pressure or diabetes&#xD;
&#xD;
          -  No other household member participating in the study&#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>Marianna Wetherill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brent Beasley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schusterman Clinic at the University of Oklahoma Health Science Center</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>April 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04421755
org study id: 10360
nct id: NCT04421755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertension and diabetes, which are increasing in prevalence, contribute to significant
      morbidity and mortality in the U.S. Self-management of these diseases, including adherence to
      dietary guidelines such as daily fruit and vegetable intake, can improve outcomes, but
      low-income patients encounter many barriers to adherence, such as food insecurity and poor
      nutrition literacy. Few clinicians screen for food insecurity, and even when screening is
      performed, there are few tested clinical response models. This study will evaluate the
      benefits of fresh fruit and vegetable home delivery program, without and with small-group
      culinary medicine cooking classes, on blood pressure and glucose control among patients
      accessing care at the University of Oklahoma Internal Medicine Clinic in Tulsa, OK. The
      Produce Drop pilot study will evaluate the feasibility and potential health benefits of a
      clinic-community partnership between OU Internal Medicine and a fresh produce home-delivery
      service provider, to promote adherence to F/V dietary guidelines among patients with
      suboptimal blood pressure and blood glucose control. Among half of those assigned to receive
      food assistance, we will evaluate the additional benefits of participation in 3-session,
      small-group, hands-on culinary medicine curriculum.
a diet rich in fruits and vegetables, is an essential requirement for optimal blood pressure
      and glucose control. Clinical practice guidelines for hypertension and diabetes both assign
      the highest grade of evidence for healthy eating behavior to treat these conditions.
      Unfortunately, fewer than one-quarter of patients adhere to dietary recommendations, with the
      largest disparities among lower socioeconomic groups and racial minorities. Patient adherence
      to nutrition guidelines are deeply hindered by poor access to fresh produce and inadequate
      knowledge about preparing medically-indicated foods. The proposed Produce Drop pilot study
      will evaluate the feasibility and potential health benefits of a fresh fruit and vegetable
      home-delivery program, with and without additional small-group culinary medicine cooking
      classes, among low-income, Medicaid patients with suboptimal blood pressure and glucose
      control. Patients (n=100) from OU-Tulsa Schusterman Internal Medicine Clinic will be
      randomized to 1) a fresh fruit and vegetable home-delivery program, or 2) the same home
      delivery program with supplementary small-group culinary medicine cooking classes. In
      addition, we will include a third arm of control patients (n=50) who will receive the
      standard of care. We will track blood pressure and glucose control in all three groups to
      determine the comparative impact of each intervention. The proposed pilot study, informed by
      the Institute for Healthcare Improvement's "Triple Aim" framework, will provide the formative
      information needed to develop a larger-scale intervention to enhance the patient care
      experience, improve population health status, and reduce the per capita cost of care.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: A randomized control trial will be used to evaluate the two interventions among a cohort of OU Internal Medicine patients. Clinical and self-report measures will be collected for the intervention arms at four time points: baseline, three months, six months, and nine months and at two time points (baseline and nine months) for the control group. After baseline measures, participants will be randomly assigned to the fruits and vegetables only group, the fruit and vegetables plus cooking classes group, or the control group. This trial will use rolling enrollment, with interventions beginning after the enrollment of enough participants to conduct an effective cooking class. Participants in the intervention groups will receive nine months of free weekly deliveries of fresh fruits and vegetables. Participants in the control group will receive a gift card valued at twenty dollars for each survey completed and an OU gift valued at ten dollars following completion of both surveys.
primary purpose: Treatment
masking: None (Open Label)
measure: Systolic blood pressure
time frame: Baseline, 3 months, 6 months, 9 months
description: change scores in systolic blood pressure at each time point
measure: Diastolic blood pressure
time frame: Baseline, 3 months, 6 months, 9 months
description: change scores in diastolic blood pressure at each time point review include age, medications, insurance, A1c, systolic blood pressure, diastolic blood pressure, weight, height, tobacco use, emergency room use, and hospitalizations. Self-report survey items include demographics, insurance, diabetes/pre-diabetes diagnosis date, hypertension diagnosis date, health literacy, medication adherence and medication scrimping, smoking status (Adult Tobacco Survey), food security (USDA 6-item food security survey), grocery shopping; food access (NEMS-P), consumption of fruit and vegetables from weekly delivery , fruit and vegetable intake (f/v checklist), food preparation/eating at home/eating out behaviors, nutrition-related quality of life (NQOL), cooking knowledge, and cooking confidence.
measure: A1c
time frame: Baseline, 3 months, 6 months, 9 months
description: change scores in A1C at each time point
measure: Food security
time frame: Baseline, 3 months, 6 months, 9 months
description: change scores on a food security scale
measure: Food environment
time frame: Baseline, 9 months
description: change scores on a food environment scale
measure: Fruit and vegetable consumption
time frame: Baseline, 9 months
description: change scores on a fruit and vegetable consumption scale
measure: Nutrition knowledge
time frame: Baseline, 9 months
description: change scores on a fruit and vegetable consumption scale
measure: Cooking skills
time frame: Baseline, 9 months
description: change scores on cooking skills scale
arm group label: Produce Only
arm group type: Experimental
description: Receives weekly home delivery of fresh fruits and vegetables
arm group label: Produce + Cooking Classes
arm group type: Experimental
description: Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes
arm group label: Control
arm group type: No Intervention
description: Control group with no cooking classes or groceries
intervention type: Other
intervention name: Produce delivery
description: weekly home delivery of fresh fruits and vegetables
arm group label: Produce + Cooking Classes
arm group label: Produce Only
intervention type: Other
intervention name: Cooking classes
description: weekly home delivery of fresh fruits and vegetables participants will be invited to participate in a Culinary Medicine cooking series. The OU Culinary Medicine cooking curriculum will involve a 3-part class series designed to build nutrition knowledge and cooking self-efficacy for preparing fresh F/Vs. Each session is ~2 hr. Core nutrition guidelines for blood pressure and blood sugar management will also be emphasized informed by an evidence-based Conceptual Model of Healthy Cooking. Classes will be conducted in small groups (~16 participants) in an established teaching kitchen used by the culinary medicine program. Classes will be facilitated by a professional chef, a healthcare professional (dietitian, medical doctor, or trained medical student), and other support staff, including trained medical, dietetic, and public health students.
arm group label: Produce + Cooking Classes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Marianna Wetherill, PhD
role: Principal Investigator
affiliation: University of Oklahoma
last name: Brent Beasley, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No