<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/NCT02976389</url>
  </required_header>
  <id_info>
    <org_study_id>2016-70025-25247</org_study_id>
    <nct_id>NCT02976389</nct_id>
  </id_info>
  <brief_title>Southern California Nutrition Incentive Program</brief_title>
  <acronym>SCNIP</acronym>
  <official_title>Southern California Nutrition Incentive Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The California Endowment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ecology Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Good Food Purchasing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northgate Gonzalez Markets</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Latino Health Access</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>California Department of Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Department of Agriculture (USDA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aims of this proposal are to implement SCNIP in 6 Northgate Gonzalez Markets&#xD;
      across San Diego, Orange and LA counties (2 in each county), and determine which level of&#xD;
      financial incentive rebate (specifically, $10/month, $20/month, or $40/month) optimally&#xD;
      increases the purchase and consumption of SNAP eligible fruits and vegetables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The University of California San Diego (UCSD) Center for Community Health, in collaboration&#xD;
      with Northgate Gonzalez Markets and its regional partners, will implement a Food Insecurity&#xD;
      Nutrition Incentive program in Los Angeles, Orange and San Diego Counties - the Southern&#xD;
      California Nutrition Incentive Program (SCNIP). This program will develop, implement and&#xD;
      evaluate a multi-tiered model that will enable low-income, SNAP-eligible consumers to make&#xD;
      healthier food choices and purchase more fruits and vegetables. This model will include: tier&#xD;
      1) an innovative fruit and vegetable financial incentive rebate program that utilizes the&#xD;
      consumer's Northgate Gonzalez Market customer loyalty card, electronic benefit transfer (EBT)&#xD;
      card, and electronic wallet (e-wallet); tier 2) fruit and vegetable promotions that include&#xD;
      discount pricing; and tier 3) SNAP-Ed programming (e.g., in-store cooking classes, tours, and&#xD;
      healthy food self-labeling system) to educate and support the purchasing behaviors of&#xD;
      SNAP-eligible families. Through the use of the customer loyalty card, EBT card, and e-wallet,&#xD;
      the rebate program will be able to track the purchase of SCNIP eligible fruits and vegetables&#xD;
      and provide a rebate at the point-of-sale that can be used to purchase additional fruits and&#xD;
      vegetables, thus increasing the purchasing power of SNAP-eligible families for healthy food&#xD;
      options. Earned and dispensed rebate dollars will be stored on the e-wallet enabling the&#xD;
      tracking of purchasing behaviors and dollars spent on healthy fruits and vegetables in this&#xD;
      program. With this data, we will be able to determine what level of financial incentive&#xD;
      rebate ($10/month, $20/month, or $40/month) (tier 1) optimally increased SNAP families' per&#xD;
      capita spending on fruits and vegetables in conjunction with the fruit and vegetable&#xD;
      promotions (tier 2) and nutrition education activities (tier 3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dollars spent on Fruits and Vegetables</measure>
    <time_frame>1 year</time_frame>
    <description>Total amount of incentive dollars spent on Fruits and Vegetables per month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantity of Fruits and Vegetables</measure>
    <time_frame>1 year</time_frame>
    <description>total quantity of fruits and vegetables purchased per month with incentive dollars</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>1 year</time_frame>
    <description>Change in self-reported fruit and vegetable consumption during the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-item short form of the Food Security Survey Module</measure>
    <time_frame>1 year</time_frame>
    <description>Change in food insecurity score at the end of the intervention period</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">3780</enrollment>
  <condition>Food Insecurity</condition>
  <arm_group>
    <arm_group_label>$40/month</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Financial incentives: Participants will be randomized to receive $40/month in incentive dollars for the purchase of SNAP eligible fruits and vegetables. Purchasing behaviors will be tracked.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>$20/month</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Financial Incentives: Participants will be randomized to receive $20/month in incentive dollars for the purchase of SNAP eligible fruits and vegetables. Purchasing behaviors will be tracked.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>$10/month</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Financial Incentives: Participants will be randomized to receive $10/month in incentive dollars for the purchase of SNAP eligible fruits and vegetables. Purchasing behaviors will be tracked.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Financial Incentive: High</intervention_name>
    <description>dlParticipants in this group will receive an additional $40/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.</description>
    <arm_group_label>$40/month</arm_group_label>
    <other_name>Mas Fresco</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Financial Incentive: Middle</intervention_name>
    <description>Participants in this group will receive an additional $20/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.</description>
    <arm_group_label>$20/month</arm_group_label>
    <other_name>Mas Fresco</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Financial Incentive: Low</intervention_name>
    <description>Participants in this group will receive an additional $10/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.</description>
    <arm_group_label>$10/month</arm_group_label>
    <other_name>Mas Fresco</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Northgate Gonzalez Market customer who currently receives SNAP benefits and has a&#xD;
             valid EBT card&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Speaks and reads in English or Spanish&#xD;
&#xD;
          -  Shops at the selected Northgate Gonzalez Market regularly, at least two times per&#xD;
             month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not receive SNAP benefits&#xD;
&#xD;
          -  Unable to complete surveys in English or Spanish&#xD;
&#xD;
          -  Another immediate family member living in the same household is already recruited into&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Kay Rhee</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Supplemental Nutrition Assistance Program</keyword>
  <keyword>Food insecurity</keyword>
  <keyword>fruit and vegetable</keyword>
  <keyword>healthy diet</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be shared with USDA on a quarterly basis. Data will include number of participants recruited, amount of incentive dollars used. USDA will determine when this data will be released</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/NCT02976389
org study id: 2016-70025-25247
nct id: NCT02976389
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The specific aims of this proposal are to implement SCNIP in 6 Northgate Gonzalez Markets
      across San Diego, Orange and LA counties (2 in each county), and determine which level of
      financial incentive rebate (specifically, $10/month, $20/month, or $40/month) optimally
      increases the purchase and consumption of SNAP eligible fruits and vegetables.
The University of California San Diego (UCSD) Center for Community Health, in collaboration
      with Northgate Gonzalez Markets and its regional partners, will implement a Food Insecurity
      Nutrition Incentive program in Los Angeles, Orange and San Diego Counties - the Southern
      California Nutrition Incentive Program (SCNIP). This program will develop, implement and
      evaluate a multi-tiered model that will enable low-income, SNAP-eligible consumers to make
      healthier food choices and purchase more fruits and vegetables. This model will include: tier
      1) an innovative fruit and vegetable financial incentive rebate program that utilizes the
      consumer's Northgate Gonzalez Market customer loyalty card, electronic benefit transfer (EBT)
      card, and electronic wallet (e-wallet); tier 2) fruit and vegetable promotions that include
      discount pricing; and tier 3) SNAP-Ed programming (e.g., in-store cooking classes, tours, and
      healthy food self-labeling system) to educate and support the purchasing behaviors of
      SNAP-eligible families. Through the use of the customer loyalty card, EBT card, and e-wallet,
      the rebate program will be able to track the purchase of SCNIP eligible fruits and vegetables
      and provide a rebate at the point-of-sale that can be used to purchase additional fruits and
      vegetables, thus increasing the purchasing power of SNAP-eligible families for healthy food
      options. Earned and dispensed rebate dollars will be stored on the e-wallet enabling the
      tracking of purchasing behaviors and dollars spent on healthy fruits and vegetables in this
      program. With this data, we will be able to determine what level of financial incentive
      rebate ($10/month, $20/month, or $40/month) (tier 1) optimally increased SNAP families' per
      capita spending on fruits and vegetables in conjunction with the fruit and vegetable
      promotions (tier 2) and nutrition education activities (tier 3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Dollars spent on Fruits and Vegetables
time frame: 1 year
description: Total amount of incentive dollars spent on Fruits and Vegetables per month
measure: Quantity of Fruits and Vegetables
time frame: 1 year
description: total quantity of fruits and vegetables purchased per month with incentive dollars
measure: Dietary intake
time frame: 1 year
description: Change in self-reported fruit and vegetable consumption during the intervention
measure: Six-item short form of the Food Security Survey Module
time frame: 1 year
description: Change in food insecurity score at the end of the intervention period
arm group label: $40/month
arm group type: Experimental
description: Financial incentives: Participants will be randomized to receive $40/month in incentive dollars for the purchase of SNAP eligible fruits and vegetables. Purchasing behaviors will be tracked.
arm group label: $20/month
arm group type: Active Comparator
description: Financial Incentives: Participants will be randomized to receive $20/month in incentive dollars for the purchase of SNAP eligible fruits and vegetables. Purchasing behaviors will be tracked.
arm group label: $10/month
arm group type: Active Comparator
description: Financial Incentives: Participants will be randomized to receive $10/month in incentive dollars for the purchase of SNAP eligible fruits and vegetables. Purchasing behaviors will be tracked.
intervention type: Other
intervention name: Financial Incentive: High
description: dlParticipants in this group will receive an additional $40/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.
arm group label: $40/month
other name: Mas Fresco
intervention type: Other
intervention name: Financial Incentive: Middle
description: Participants in this group will receive an additional $20/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.
arm group label: $20/month
other name: Mas Fresco
intervention type: Other
intervention name: Financial Incentive: Low
description: Participants in this group will receive an additional $10/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.
arm group label: $10/month
other name: Mas Fresco
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kay Rhee
investigator title: Associate Professor of Pediatrics
sharing ipd: No
ipd description: Data will be shared with USDA on a quarterly basis. Data will include number of participants recruited, amount of incentive dollars used. USDA will determine when this data will be released