<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/NCT03026608</url>
  </required_header>
  <id_info>
    <org_study_id>12-1689</org_study_id>
    <nct_id>NCT03026608</nct_id>
  </id_info>
  <brief_title>Green Cart Program Evaluation</brief_title>
  <official_title>Impact of a Public-Private Mobile Market to Improve Fruit &amp; Vegetable Access</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University at Buffalo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce&#xD;
      market on access to healthy food and fruit and vegetable intake in 12 lower-income&#xD;
      communities using a cluster-randomized design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lower-income and minority groups face significant health disparities with respect to obesity,&#xD;
      cancer, heart disease and other chronic conditions. Poor diets, low in fruits and vegetables&#xD;
      (F&amp;V) and high in saturated fat, sodium and sugar, contribute to many of the health problems&#xD;
      faced by vulnerable groups. While poverty, low-educational attainment and personal food&#xD;
      preference are all associated with reduced F&amp;V consumption, these individual-level factors&#xD;
      must be viewed in an environmental context. Research has repeatedly demonstrated the&#xD;
      important role that environment plays on health decisions and behaviors. Compared with&#xD;
      higher-income neighborhoods, lower-income and minority neighborhoods are less likely to have&#xD;
      a supermarket that sells a variety of F&amp;V and other healthy foods. This is perpetuated by an&#xD;
      underlying misconception that there is limited demand or potential profit for new healthy&#xD;
      food ventures in these communities. In the few cases where new food outlets have opened in&#xD;
      underserved areas, they have been met with substantial customer support. The NC Green Cart&#xD;
      program, which our team has already been funded to lead, uses a weekly mobile market model to&#xD;
      deliver low-cost boxes of fresh F&amp;V to easily accessible community locations (such as&#xD;
      churches and day care centers) and provide nutrition and cooking education. This program&#xD;
      builds upon burgeoning support for a local sustainable food system in NC and leverages a&#xD;
      public-private partnership to increase access to fresh F&amp;V in underserved communities. While&#xD;
      current program funding allows for minimal evaluation, the present study hopes to demonstrate&#xD;
      that selling affordable, accessible F&amp;V in lower-income communities is not only financially&#xD;
      viable, but can impact behavioral risk factors of individuals in target communities. Working&#xD;
      together with the Green Cart program team, this research will 1.) measure the impact of a&#xD;
      mobile market at 6, 12 and 18 months on the primary outcome of F&amp;V consumption as well as&#xD;
      BMI, perceived access to F&amp;V, and self-efficacy to purchase, prepare, serve and eat fresh F&amp;V&#xD;
      using a randomized controlled design; and 2.) assess community support, feasibility, and&#xD;
      financial sustainability of the public-private Green Cart partnership. Results of this&#xD;
      research will inform our understanding of how the food environment impacts dietary choices&#xD;
      and provide evidence for researchers, businesses, non-profits and policy makers on the&#xD;
      potential impact and viability of using similar models to reduce food access disparities and&#xD;
      improve diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fruit and Vegetable Consumption</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>Measured via food frequency questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Score for Perceived access to fresh fruits and vegetables</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>At each time point, a three-question perceived access scale was used to measure participants' perceptions of access to fresh fruits and vegetables in (1) their neighborhood, (2) the area surrounding the VV community site, and (3) in general. Questions included 1) &quot;It is easy to buy fresh fruits and vegetables [in my neighborhood/around community sites/ in general];&quot; 2) &quot;There is a large selection of fresh fruits and vegetables [in my neighborhood/around community site/in general];&quot; 3) &quot;The fresh fruits and vegetables [in my neighborhood/around community site/in general] are high quality.&quot; For all perceived access questions, participants chose responses from a 5-point Likert scale ranging from &quot;Strongly Agree&quot; = 5 to &quot;Strongly Disagree&quot; = 1. Each three item scaled was summed to create a perceived access score by location (range 3-15). Higher scores at each time point indicate higher perceived access and positive changes indicate increases in access from baseline to 6 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Body Mass Index</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>measured via self-reported height and weight</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Fruit and Vegetable Consumption</condition>
  <condition>Food Insecurity</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Communities randomized to the intervention group receive the Veggie Van program shortly after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Intervention Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive the Veggie Van intervention approximately 6 months after baseline data collection and randomization (after the collection of 6 months outcomes data).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Veggie Van Program</intervention_name>
    <description>This includes 1.) Weekly delivery of fresh local produce; 2.) Cooking and nutrition demonstrations; 3.) Weekly newsletters about cooking, nutrition and local produce mailed to all study participants and distributed at Veggie Van</description>
    <arm_group_label>Delayed Intervention Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receives services or lives within one of the communities selected for the study&#xD;
&#xD;
          -  Main shopper for the household&#xD;
&#xD;
          -  Intends to use Veggie Van if it comes to their community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice Ammerman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual data</ipd_description>
  </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/NCT03026608
org study id: 12-1689
nct id: NCT03026608
lead sponsor: 
collaborator: 
has dmc: No
The Green Car Evaluation was designed to test the impact of the Veggie Van mobile produce
      market on access to healthy food and fruit and vegetable intake in 12 lower-income
      communities using a cluster-randomized design.
Lower-income and minority groups face significant health disparities with respect to obesity,
      cancer, heart disease and other chronic conditions. Poor diets, low in fruits and vegetables
      (F&V) and high in saturated fat, sodium and sugar, contribute to many of the health problems
      faced by vulnerable groups. While poverty, low-educational attainment and personal food
      preference are all associated with reduced F&V consumption, these individual-level factors
      must be viewed in an environmental context. Research has repeatedly demonstrated the
      important role that environment plays on health decisions and behaviors. Compared with
      higher-income neighborhoods, lower-income and minority neighborhoods are less likely to have
      a supermarket that sells a variety of F&V and other healthy foods. This is perpetuated by an
      underlying misconception that there is limited demand or potential profit for new healthy
      food ventures in these communities. In the few cases where new food outlets have opened in
      underserved areas, they have been met with substantial customer support. The NC Green Cart
      program, which our team has already been funded to lead, uses a weekly mobile market model to
      deliver low-cost boxes of fresh F&V to easily accessible community locations (such as
      churches and day care centers) and provide nutrition and cooking education. This program
      builds upon burgeoning support for a local sustainable food system in NC and leverages a
      public-private partnership to increase access to fresh F&V in underserved communities. While
      current program funding allows for minimal evaluation, the present study hopes to demonstrate
      that selling affordable, accessible F&V in lower-income communities is not only financially
      viable, but can impact behavioral risk factors of individuals in target communities. Working
      together with the Green Cart program team, this research will 1.) measure the impact of a
      mobile market at 6, 12 and 18 months on the primary outcome of F&V consumption as well as
      BMI, perceived access to F&V, and self-efficacy to purchase, prepare, serve and eat fresh F&V
      using a randomized controlled design; and 2.) assess community support, feasibility, and
      financial sustainability of the public-private Green Cart partnership. Results of this
      research will inform our understanding of how the food environment impacts dietary choices
      and provide evidence for researchers, businesses, non-profits and policy makers on the
      potential impact and viability of using similar models to reduce food access disparities and
      improve diet.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Fruit and Vegetable Consumption
time frame: Change from baseline to 6 months
description: Measured via food frequency questionnaire
measure: Change Score for Perceived access to fresh fruits and vegetables
time frame: Change from baseline to 6 months
description: At each time point, a three-question perceived access scale was used to measure participants' perceptions of access to fresh fruits and vegetables in (1) their neighborhood, (2) the area surrounding the VV community site, and (3) in general. Questions included 1) "It is easy to buy fresh fruits and vegetables [in my neighborhood/around community sites/ in general];" 2) "There is a large selection of fresh fruits and vegetables [in my neighborhood/around community site/in general];" 3) "The fresh fruits and vegetables [in my neighborhood/around community site/in general] are high quality." For all perceived access questions, participants chose responses from a 5-point Likert scale ranging from "Strongly Agree" = 5 to "Strongly Disagree" = 1. Each three item scaled was summed to create a perceived access score by location (range 3-15). Higher scores at each time point indicate higher perceived access and positive changes indicate increases in access from baseline to 6 months.
measure: Change in Body Mass Index
time frame: Change from baseline to 6 months
description: measured via self-reported height and weight
arm group label: Intervention Group
arm group type: Experimental
description: Communities randomized to the intervention group receive the Veggie Van program shortly after randomization.
arm group label: Delayed Intervention Control Group
arm group type: Active Comparator
description: This group will receive the Veggie Van intervention approximately 6 months after baseline data collection and randomization (after the collection of 6 months outcomes data).
intervention type: Behavioral
intervention name: Veggie Van Program
description: This includes 1.) Weekly delivery of fresh local produce; 2.) Cooking and nutrition demonstrations; 3.) Weekly newsletters about cooking, nutrition and local produce mailed to all study participants and distributed at Veggie Van
arm group label: Delayed Intervention Control Group
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alice Ammerman, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan to share individual data