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/NCT05978843</url>
    </required_header>
    <id_info>
      <org_study_id>A999999</org_study_id>
      <nct_id>NCT05978843</nct_id>
    </id_info>
    <brief_title>Comparison of Produce Prescription Benefit Dosage</brief_title>
    <official_title>Comparison of Produce Prescription Benefit Dosage on Redemption</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</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>
        The goal of this study is to determine the relationship between produce prescription program&#xD;
        'dose' on benefit redemption, food insecurity, and fruit and vegetable consumption.&#xD;
        Participants will be randomized to receive one of three fruit and vegetable benefit dose&#xD;
        amounts for 6 months ($40, $80, or $110/month).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Emerging evidence from the growing body of research around 'Food is Medicine' interventions&#xD;
        shows promise that produce prescriptions (PPR) improve health by enabling purchases of&#xD;
        healthy foods, reducing food insecurity, and improving diet quality. However, PPR amounts are&#xD;
        often set seemingly arbitrarily, without clear connection to their intended purpose. In this&#xD;
        study, investigators will conduct a three-armed randomized trial of 240 participants in&#xD;
        Stockton, CA to test the impact of three 'doses' of a fruit and vegetable benefit on benefit&#xD;
        redemption, food security, and fruit and vegetable intake. The goal of this study is to&#xD;
        determine the relationship between PPR program 'dose' and the key intermediate outcomes of&#xD;
        benefit redemption (primary outcome), food insecurity, and consumption of incentivized foods&#xD;
        (secondary outcomes). Investigators will also seek to identify any 'ceiling effect' above&#xD;
        which further increases in benefit value do not lead to further benefit redemption. This will&#xD;
        be highly informative for subsequent PPR research. Investigators will leverage the existing&#xD;
        infrastructure of the Vouchers 4 Veggies - EatSF produce prescription program to ensure&#xD;
        feasibility.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 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>
      <intervention_model_description>Participants will be randomized into one of three arms. Each arm will receive a different benefit amount during the 6-month intervention period, with benefit amounts determined by a percentage of the Thrifty Food Plan (TFP) - the USDA food plan used to calculate SNAP benefit rates. For ethical reasons, participants will each receive the same total benefit amount over the course of the study, with those randomized to the lower benefit arms receiving the difference between the value of the benefits issued to them and the value of the benefits issued to the highest dose group as a lump sum payment at the end of the study.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Benefit redemption</measure>
      <time_frame>Monthly for 6 months</time_frame>
      <description>Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fruit and vegetable consumption</measure>
      <time_frame>0, 3, and 6 months</time_frame>
      <description>Measured by NCI Dietary Screener Questionnaire (DSQ) and reported in cup-equivalents, a higher score indicates greater fruit and vegetable intake (better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Food security status</measure>
      <time_frame>0, 3, and 6 months</time_frame>
      <description>Measured by USDA 6-item food security module, scale of 0-6, a higher score indicates more severe food insecurity (worse outcome); Scores converted to Rasch measurement scale, scale of 0-8.48, a higher score indicates more severe food insecurity</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Food Insecurity</condition>
    <arm_group>
      <arm_group_label>Arm 1 - 10% TFP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive $40/month in fruit and vegetable benefits for 6 months ($240 total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2 - 20% TFP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive $80/month in fruit and vegetable benefits for 6 months ($480 total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 3 - 30% TFP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive $110/month in fruit and vegetable benefits for 6 months ($660).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Monetary benefit to purchase fruits and vegetables</intervention_name>
      <description>Participants will receive varying benefit amounts to purchase fruits and vegetables.</description>
      <arm_group_label>Arm 1 - 10% TFP</arm_group_label>
      <arm_group_label>Arm 2 - 20% TFP</arm_group_label>
      <arm_group_label>Arm 3 - 30% TFP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individual receiving services at El Concilio, located in Stockton, CA&#xD;
  &#xD;
            -  Age 18+&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  Literacy sufficient to complete a written survey&#xD;
  &#xD;
            -  Technologic capacity to complete an online survey&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  non English or Spanish speaking&#xD;
  &#xD;
            -  cognitive impairment severe enough to interfere with understanding of the survey or&#xD;
               consent form, whether due to cognitive delay, substance abuse, dementia, mental&#xD;
               illness, or other etiologies&#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>
    <overall_official>
      <last_name>Hilary Seligman, MD, MAS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hilary Seligman, MD, MAS</last_name>
      <phone>(628) 206-4448</phone>
      <email>hilary.seligman@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ronli Levi, MPH, RD</last_name>
      <phone>510-847-1951</phone>
      <email>ronli.levi@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California, San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Hilary Seligman, MD, MAS</last_name>
        <phone>628-206-4448</phone>
        <email>hilary.seligman@ucsf.edu</email>
      </contact>
      <contact_backup>
        <last_name>Ronli Levi, MPH, RD</last_name>
        <phone>510-847-1951</phone>
        <email>ronli.levi@ucsf.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Berkowitz SA, Baggett TP, Wexler DJ, Huskey KW, Wee CC. Food insecurity and metabolic control among U.S. adults with diabetes. Diabetes Care. 2013 Oct;36(10):3093-9. doi: 10.2337/dc13-0570. Epub 2013 Jun 11.</citation>
      <PMID>23757436</PMID>
    </reference>
    <reference>
      <citation>Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039.</citation>
      <PMID>33999108</PMID>
    </reference>
    <reference>
      <citation>Seligman HK, Laraia BA, Kushel MB. Food insecurity is associated with chronic disease among low-income NHANES participants. J Nutr. 2010 Feb;140(2):304-10. doi: 10.3945/jn.109.112573. Epub 2009 Dec 23. Erratum In: J Nutr. 2011 Mar;141(3):542.</citation>
      <PMID>20032485</PMID>
    </reference>
    <reference>
      <citation>Ridberg RA, Bell JF, Merritt KE, Harris DM, Young HM, Tancredi DJ. Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Prev Chronic Dis. 2019 Jun 13;16:E73. doi: 10.5888/pcd16.180555.</citation>
      <PMID>31198165</PMID>
    </reference>
    <reference>
      <citation>Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.</citation>
      <PMID>35684128</PMID>
    </reference>
    <reference>
      <citation>Stotz SA, Budd Nugent N, Ridberg R, Byker Shanks C, Her K, Yaroch AL, Seligman H. Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. Prev Med Rep. 2022 Aug 13;29:101951. doi: 10.1016/j.pmedr.2022.101951. eCollection 2022 Oct.</citation>
      <PMID>36161127</PMID>
    </reference>
    <reference>
      <citation>Xie J, Price A, Curran N, Ostbye T. The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr. 2021 Aug;24(12):3945-3955. doi: 10.1017/S1368980021001828. Epub 2021 Apr 27.</citation>
      <PMID>33902771</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</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">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05978843
  org study id: A999999
  nct id: NCT05978843
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to determine the relationship between produce prescription program
        'dose' on benefit redemption, food insecurity, and fruit and vegetable consumption.
        Participants will be randomized to receive one of three fruit and vegetable benefit dose
        amounts for 6 months ($40, $80, or $110/month).
  Emerging evidence from the growing body of research around 'Food is Medicine' interventions
        shows promise that produce prescriptions (PPR) improve health by enabling purchases of
        healthy foods, reducing food insecurity, and improving diet quality. However, PPR amounts are
        often set seemingly arbitrarily, without clear connection to their intended purpose. In this
        study, investigators will conduct a three-armed randomized trial of 240 participants in
        Stockton, CA to test the impact of three 'doses' of a fruit and vegetable benefit on benefit
        redemption, food security, and fruit and vegetable intake. The goal of this study is to
        determine the relationship between PPR program 'dose' and the key intermediate outcomes of
        benefit redemption (primary outcome), food insecurity, and consumption of incentivized foods
        (secondary outcomes). Investigators will also seek to identify any 'ceiling effect' above
        which further increases in benefit value do not lead to further benefit redemption. This will
        be highly informative for subsequent PPR research. Investigators will leverage the existing
        infrastructure of the Vouchers 4 Veggies - EatSF produce prescription program to ensure
        feasibility.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized into one of three arms. Each arm will receive a different benefit amount during the 6-month intervention period, with benefit amounts determined by a percentage of the Thrifty Food Plan (TFP) - the USDA food plan used to calculate SNAP benefit rates. For ethical reasons, participants will each receive the same total benefit amount over the course of the study, with those randomized to the lower benefit arms receiving the difference between the value of the benefits issued to them and the value of the benefits issued to the highest dose group as a lump sum payment at the end of the study.
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: Benefit redemption
  time frame: Monthly for 6 months
  description: Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)
  measure: Fruit and vegetable consumption
  time frame: 0, 3, and 6 months
  description: Measured by NCI Dietary Screener Questionnaire (DSQ) and reported in cup-equivalents, a higher score indicates greater fruit and vegetable intake (better outcome)
  measure: Food security status
  time frame: 0, 3, and 6 months
  description: Measured by USDA 6-item food security module, scale of 0-6, a higher score indicates more severe food insecurity (worse outcome); Scores converted to Rasch measurement scale, scale of 0-8.48, a higher score indicates more severe food insecurity
  arm group label: Arm 1 - 10% TFP
  arm group type: Active Comparator
  description: Participants will receive $40/month in fruit and vegetable benefits for 6 months ($240 total).
  arm group label: Arm 2 - 20% TFP
  arm group type: Active Comparator
  description: Participants will receive $80/month in fruit and vegetable benefits for 6 months ($480 total).
  arm group label: Arm 3 - 30% TFP
  arm group type: Active Comparator
  description: Participants will receive $110/month in fruit and vegetable benefits for 6 months ($660).
  intervention type: Behavioral
  intervention name: Monetary benefit to purchase fruits and vegetables
  description: Participants will receive varying benefit amounts to purchase fruits and vegetables.
  arm group label: Arm 1 - 10% TFP
  arm group label: Arm 2 - 20% TFP
  arm group label: Arm 3 - 30% TFP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hilary Seligman, MD, MAS
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Hilary Seligman, MD, MAS
  phone: (628) 206-4448
  email: hilary.seligman@ucsf.edu
  last name: Ronli Levi, MPH, RD
  phone: 510-847-1951
  email: ronli.levi@ucsf.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  citation: Berkowitz SA, Baggett TP, Wexler DJ, Huskey KW, Wee CC. Food insecurity and metabolic control among U.S. adults with diabetes. Diabetes Care. 2013 Oct;36(10):3093-9. doi: 10.2337/dc13-0570. Epub 2013 Jun 11.
  PMID: 23757436
  citation: Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039.
  PMID: 33999108
  citation: Seligman HK, Laraia BA, Kushel MB. Food insecurity is associated with chronic disease among low-income NHANES participants. J Nutr. 2010 Feb;140(2):304-10. doi: 10.3945/jn.109.112573. Epub 2009 Dec 23. Erratum In: J Nutr. 2011 Mar;141(3):542.
  PMID: 20032485
  citation: Ridberg RA, Bell JF, Merritt KE, Harris DM, Young HM, Tancredi DJ. Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Prev Chronic Dis. 2019 Jun 13;16:E73. doi: 10.5888/pcd16.180555.
  PMID: 31198165
  citation: Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.
  PMID: 35684128
  citation: Stotz SA, Budd Nugent N, Ridberg R, Byker Shanks C, Her K, Yaroch AL, Seligman H. Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. Prev Med Rep. 2022 Aug 13;29:101951. doi: 10.1016/j.pmedr.2022.101951. eCollection 2022 Oct.
  PMID: 36161127
  citation: Xie J, Price A, Curran N, Ostbye T. The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr. 2021 Aug;24(12):3945-3955. doi: 10.1017/S1368980021001828. Epub 2021 Apr 27.
  PMID: 33902771
  responsible party type: Sponsor
  sharing ipd: No