<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/NCT03231592</url>
  </required_header>
  <id_info>
    <org_study_id>FMPP2016</org_study_id>
    <nct_id>NCT03231592</nct_id>
  </id_info>
  <brief_title>Im(Proving) the CSA Model</brief_title>
  <official_title>Im(Proving) the CSA Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Community Health Center of Franklin County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Just Roots</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Community Health Center of Franklin County</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>
      In 1986, The Pioneer Valley in Western Massachusetts was home to one of the first two&#xD;
      community supported agriculture (CSA) businesses in the USA. In 2014, there were 6,200 CSAs&#xD;
      across the states, and today, in the Pioneer Valley alone, there are sixty CSAs. As with many&#xD;
      parts of the United States, there are too many CSAs competing for the same pool of middle and&#xD;
      upper-class customers. In his research at the University of Massachusetts in 2014, Mark Paul&#xD;
      stated CSA farms are trapped in a lose-lose conundrum in which the farmers are not making&#xD;
      enough money for a living wage, while simultaneously CSA shares are too expensive for many&#xD;
      community members. The central challenge facing the CSA model moving forward is to provide&#xD;
      fair compensation to farmers and farm workers, while making shares available at prices that&#xD;
      can attract more members of the community. &quot;(Im)Proving the CSA Model&quot; proposes to increase&#xD;
      consumption of and access to local products AND to develop new market opportunities for farms&#xD;
      by opening the CSA membership base nationwide to low-income consumers and more price&#xD;
      conscious middle class consumers. The investigators will do this by researching and&#xD;
      documenting the health benefits of belonging to a CSA program. The investigators expect the&#xD;
      resulting data to justify insurance-provided cash &quot;wellness&quot; benefits for CSA participation,&#xD;
      much like those currently provided for gym membership. A wellness benefit will provide the&#xD;
      financial incentive necessary to open CSA programs to lower- and middle-income consumers.&#xD;
&#xD;
      The two-year research study intends to demonstrate that enrolling community health center&#xD;
      patients in a Community Supported Agriculture (CSA) program is feasible and leads to dietary&#xD;
      improvements that would be expected to offer clinical benefits in larger scale studies over&#xD;
      longer timeframes. To maximize the knowledge gained from participation in this study, the&#xD;
      investigators will measure several self-reported, laboratory, and clinical outcomes, but the&#xD;
      primary purpose of this study is to provide pilot data for the model.&#xD;
&#xD;
      To test this the investigators will implement a randomized controlled clinical trial design,&#xD;
      with individual-level randomization of 120 participants, assigned in 1:1 ratio to receipt of&#xD;
      a CSA membership (goal: 60 participants) or enhanced usual care (goal: 60 participants).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Full study protocol is available upon request from Rochelle Bellin&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HEI2010 Score</measure>
    <time_frame>19 months</time_frame>
    <description>The HEI 2010 score is an indicator of dietary quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>19 months</time_frame>
    <description>We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Estimate the return on investment of CSA membership</measure>
    <time_frame>19 months</time_frame>
    <description>To estimate the return on investment of CSA membership. We will use effects on dietary quality and quality of life obtained from Outcome 1 and employ an existing microsimulation model of health expenditures to determine the change in health expenditures attributable to program participation divided by the costs of the program to calculate the 'return on investment'. The focus of our analysis will be identifying health effects that are relevant to accountable care organizations and insurers with the goal of informing adoption of the CSA model.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>19 months</time_frame>
    <description>Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>19 months</time_frame>
    <description>Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>19 months</time_frame>
    <description>Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipids</measure>
    <time_frame>19 months</time_frame>
    <description>Non-fasting lipid panels (including total cholesterol, HDL, triglycerides, and LDL if calculable). This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Food Insecurity</measure>
    <time_frame>19 months</time_frame>
    <description>USDA Food Security Survey module, 10 adult referenced items, modified to have a 1 month look back period, using standard scoring. This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety Symptoms</measure>
    <time_frame>19 months</time_frame>
    <description>Measured using the PROMIS Emotional Distress Anxiety 4 item short-form.This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>19 months</time_frame>
    <description>Measured using the PROMIS Emotional Distress Depression 4 item short-form. This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost Related Medication Underuse</measure>
    <time_frame>19 months</time_frame>
    <description>Measured using the 4 cost-related medication underuse items from MEPS/NHISThis is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <other_outcome>
    <measure>Food-Medication Trade-Offs</measure>
    <time_frame>19 months</time_frame>
    <description>4 questions about trade-offs between affording food, medications, and meeting other basic needs. This is an exploratory outcome and the study is not necessarily powered to detect changes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Nutrition Poor</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>CSA Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive CSA Shares (a selection of fresh fruits and vegetables from a local farm) each week for 24 weeks over the summer of 2017 and 2018. The CSA does not operate over the winter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive a handout about healthy eating, in addition to routine care in their primary care practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CSA Group</intervention_name>
    <description>Already included in the arm descriptions.</description>
    <arm_group_label>CSA Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Usual Care Group</intervention_name>
    <description>Already included in the arm descriptions.</description>
    <arm_group_label>Enhanced Usual Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2 in the past 1 year&#xD;
&#xD;
          -  Willing to commit to random assignment to either receive CSA membership or enhanced&#xD;
             care control&#xD;
&#xD;
          -  Stable health, with no severe medical comorbidities that might interfere with their&#xD;
             ability to participate in the intervention, such as severe psychiatric illness or&#xD;
             imminent hospitalization&#xD;
&#xD;
          -  Be willing to keep a food diary for one week&#xD;
&#xD;
          -  Be willing to attend and complete 5 examinations&#xD;
&#xD;
          -  Be able to understand and communicate effectively in English&#xD;
&#xD;
          -  Ability to store and prepare food&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not be pregnant or planning pregnancy in the next year&#xD;
&#xD;
          -  Currently enrolled in another study of dietary quality&#xD;
&#xD;
          -  Life threatening food allergy to component of CSA boxes&#xD;
&#xD;
          -  Currently enrolled in other CSA, or planning to enroll in CSA if assigned to enhanced&#xD;
             usual care control group&#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>Edward Sayer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Community Health Center of Franklin County</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rochelle Bellin</last_name>
    <phone>(413) 325-8969</phone>
    <email>rochelle@justroots.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Edward Sayer</last_name>
    <phone>(413) 325-8500</phone>
    <phone_ext>108</phone_ext>
    <email>edward.sayer@chcfc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Community Health Center of Franklin County</name>
      <address>
        <city>Greenfield</city>
        <state>Massachusetts</state>
        <zip>01301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edward Sayer</last_name>
      <phone>413-325-8500</phone>
      <phone_ext>108</phone_ext>
      <email>edward.sayer@chcfc.org</email>
    </contact>
    <contact_backup>
      <last_name>Maegan Petrie</last_name>
      <phone>(413) 325-8500</phone>
      <phone_ext>128</phone_ext>
      <email>Maegan.Petrie@chcfc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Rochelle Bellin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Seth A Berkowitz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://asa24.nci.nih.gov/</url>
    <description>24-hour dietary recall tool to be used at each Research Visit to assess participants previous 24 hours of consumption</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>May 9, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</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>Overweight</mesh_term>
    <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/NCT03231592
org study id: FMPP2016
nct id: NCT03231592
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In 1986, The Pioneer Valley in Western Massachusetts was home to one of the first two
      community supported agriculture (CSA) businesses in the USA. In 2014, there were 6,200 CSAs
      across the states, and today, in the Pioneer Valley alone, there are sixty CSAs. As with many
      parts of the United States, there are too many CSAs competing for the same pool of middle and
      upper-class customers. In his research at the University of Massachusetts in 2014, Mark Paul
      stated CSA farms are trapped in a lose-lose conundrum in which the farmers are not making
      enough money for a living wage, while simultaneously CSA shares are too expensive for many
      community members. The central challenge facing the CSA model moving forward is to provide
      fair compensation to farmers and farm workers, while making shares available at prices that
      can attract more members of the community. "(Im)Proving the CSA Model" proposes to increase
      consumption of and access to local products AND to develop new market opportunities for farms
      by opening the CSA membership base nationwide to low-income consumers and more price
      conscious middle class consumers. The investigators will do this by researching and
      documenting the health benefits of belonging to a CSA program. The investigators expect the
      resulting data to justify insurance-provided cash "wellness" benefits for CSA participation,
      much like those currently provided for gym membership. A wellness benefit will provide the
      financial incentive necessary to open CSA programs to lower- and middle-income consumers.

      The two-year research study intends to demonstrate that enrolling community health center
      patients in a Community Supported Agriculture (CSA) program is feasible and leads to dietary
      improvements that would be expected to offer clinical benefits in larger scale studies over
      longer timeframes. To maximize the knowledge gained from participation in this study, the
      investigators will measure several self-reported, laboratory, and clinical outcomes, but the
      primary purpose of this study is to provide pilot data for the model.

      To test this the investigators will implement a randomized controlled clinical trial design,
      with individual-level randomization of 120 participants, assigned in 1:1 ratio to receipt of
      a CSA membership (goal: 60 participants) or enhanced usual care (goal: 60 participants).
Full study protocol is available upon request from Rochelle Bellin
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: HEI2010 Score
time frame: 19 months
description: The HEI 2010 score is an indicator of dietary quality.
measure: Health Related Quality of Life
time frame: 19 months
description: We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life
measure: Estimate the return on investment of CSA membership
time frame: 19 months
description: To estimate the return on investment of CSA membership. We will use effects on dietary quality and quality of life obtained from Outcome 1 and employ an existing microsimulation model of health expenditures to determine the change in health expenditures attributable to program participation divided by the costs of the program to calculate the 'return on investment'. The focus of our analysis will be identifying health effects that are relevant to accountable care organizations and insurers with the goal of informing adoption of the CSA model.
measure: BMI
time frame: 19 months
description: Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Blood Pressure
time frame: 19 months
description: Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Hemoglobin A1c
time frame: 19 months
description: Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Lipids
time frame: 19 months
description: Non-fasting lipid panels (including total cholesterol, HDL, triglycerides, and LDL if calculable). This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Food Insecurity
time frame: 19 months
description: USDA Food Security Survey module, 10 adult referenced items, modified to have a 1 month look back period, using standard scoring. This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Anxiety Symptoms
time frame: 19 months
description: Measured using the PROMIS Emotional Distress Anxiety 4 item short-form.This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Depressive Symptoms
time frame: 19 months
description: Measured using the PROMIS Emotional Distress Depression 4 item short-form. This is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Cost Related Medication Underuse
time frame: 19 months
description: Measured using the 4 cost-related medication underuse items from MEPS/NHISThis is an exploratory outcome and the study is not necessarily powered to detect changes
measure: Food-Medication Trade-Offs
time frame: 19 months
description: 4 questions about trade-offs between affording food, medications, and meeting other basic needs. This is an exploratory outcome and the study is not necessarily powered to detect changes
arm group label: CSA Group
arm group type: Experimental
description: This group will receive CSA Shares (a selection of fresh fruits and vegetables from a local farm) each week for 24 weeks over the summer of 2017 and 2018. The CSA does not operate over the winter.
arm group label: Enhanced Usual Care Group
arm group type: Active Comparator
description: This group will receive a handout about healthy eating, in addition to routine care in their primary care practice.
intervention type: Other
intervention name: CSA Group
description: Already included in the arm descriptions.
arm group label: CSA Group
intervention type: Other
intervention name: Enhanced Usual Care Group
description: Already included in the arm descriptions.
arm group label: Enhanced Usual Care Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Edward Sayer
role: Principal Investigator
affiliation: Community Health Center of Franklin County
last name: Rochelle Bellin
phone: (413) 325-8969
email: rochelle@justroots.org
last name: Edward Sayer
phone: (413) 325-8500
phone ext: 108
email: edward.sayer@chcfc.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
url: https://asa24.nci.nih.gov/
description: 24-hour dietary recall tool to be used at each Research Visit to assess participants previous 24 hours of consumption
responsible party type: Sponsor
mesh term: Overweight
mesh term: Malnutrition
sharing ipd: No