<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/NCT03246997</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 16-0031</org_study_id>
    <nct_id>NCT03246997</nct_id>
  </id_info>
  <brief_title>Project Powerfood: Promoting Food Security, Equity, and Health</brief_title>
  <official_title>Project Powerfood: Promoting Food Security, Equity, and Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York Common Pantry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Corbin Hill Food Project</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wholesome Wave</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
      Project Powerfood is a pilot program aimed at addressing food insecurity and food access in&#xD;
      primary care through the implementation of a food prescription program in collaboration with&#xD;
      a number of community partners. The objectives of this project are:&#xD;
&#xD;
        1. Implement screening for food insecurity in adult and pediatric primary care practices at&#xD;
           Mount Sinai.&#xD;
&#xD;
        2. Provide fresh fruit and vegetable &quot;prescriptions&quot; to be redeemed for farm shares from&#xD;
           local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a&#xD;
           fruit and vegetable box. Participants will have the option to purchase 2 boxes per month&#xD;
           for 6 months.&#xD;
&#xD;
        3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese&#xD;
           children who are food insecure and/or receive SNAP and/or WIC benefits.&#xD;
           Examine/evaluate:&#xD;
&#xD;
             1. Feasibility of program in a busy primary care practice&#xD;
&#xD;
             2. Outcomes before and after the intervention (at baseline, 6 and 12 months),&#xD;
                including diet, diabetes control, and body mass index (BMI)&#xD;
&#xD;
             3. Outcomes in a comparison group (that will receive the food prescriptions beginning&#xD;
                at 6 months)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2017</start_date>
  <completion_date type="Actual">March 29, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 2019</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 are enrolled in the study and randomly assigned to the immediate intervention or the delayed intervention group. Participants in the immediate intervention group will receive the intervention for 6 months with a 6-month and 12-month follow-up starting from day one of enrollment. Participants in the delayed intervention group will receive the intervention beginning 6 months after enrollment with a 6-month and 12-month follow-up starting from day one of enrollment.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of farm shares picked-up</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Number of farm shares picked-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall satisfaction score</measure>
    <time_frame>up to 12 months</time_frame>
    <description>overall satisfaction with the program measured by likelihood of recommending the program to a friend on a 4 point scale 1 = not likely at all, 2 = somewhat likely, 3 = likely 4 = very likely</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Eating Index</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Diet quality, defined by the Health Eating Index which will be derived from the completion of 2 24-hour dietary recalls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The child participant's body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>USDA US Household Food Security Survey</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Food Insecurity as measured by an 18-item Self reported concern about being able to afford food or have access to food at the end of a given month. Responses to the questions in the food security survey module are combined into a scale using non-linear statistical methods based on the Rasch measurement model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c level</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The adult participant's glycemic control (as measured by hemoglobin A1c)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Diabetes Self Efficacy as measured by Self reported feelings on one's ability to control and manage their diabetes. 8-item survey, total range from 8 (not at all confident) to 80 (totally confident).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Cooking attitudes as measured by self reported attitudes about cooking and the use of the provided fresh fruits and vegetables to provide food to themselves and or their families.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Autumn Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intervention Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spring Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Delayed Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autumn Group</intervention_name>
    <description>The intervention is participating in a fruit and vegetable farm share for 6 months.</description>
    <arm_group_label>Autumn Group</arm_group_label>
    <other_name>Fresh fruit and vegetable subsidy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spring Group</intervention_name>
    <description>The intervention is participating in a fruit and vegetable farm share for 6 months.</description>
    <arm_group_label>Spring Group</arm_group_label>
    <other_name>Fresh fruit and vegetable subsidy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Food insecure and/or receive SNAP and/or WIC&#xD;
&#xD;
          -  Adult patients: poorly-controlled diabetes (hemoglobin A1c greater than 8.0%)&#xD;
&#xD;
          -  Pediatric patients: obesity, ages 5-11&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food secure and do not receive SNAP or WIC&#xD;
&#xD;
          -  Adult Patients: do not have diabetes&#xD;
&#xD;
          -  Pediatric Patients: not obese, under 5 years old or between 11 and 18&#xD;
&#xD;
          -  Speak neither English or Spanish&#xD;
&#xD;
          -  Severe kidney disease (Chronic Kidney Disease (CKD Stage IV or V)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Mayer, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food Insecure</keyword>
  <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/NCT03246997
org study id: GCO 16-0031
nct id: NCT03246997
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Project Powerfood is a pilot program aimed at addressing food insecurity and food access in
      primary care through the implementation of a food prescription program in collaboration with
      a number of community partners. The objectives of this project are:

        1. Implement screening for food insecurity in adult and pediatric primary care practices at
           Mount Sinai.

        2. Provide fresh fruit and vegetable "prescriptions" to be redeemed for farm shares from
           local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a
           fruit and vegetable box. Participants will have the option to purchase 2 boxes per month
           for 6 months.

        3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese
           children who are food insecure and/or receive SNAP and/or WIC benefits.
           Examine/evaluate:

             1. Feasibility of program in a busy primary care practice

             2. Outcomes before and after the intervention (at baseline, 6 and 12 months),
                including diet, diabetes control, and body mass index (BMI)

             3. Outcomes in a comparison group (that will receive the food prescriptions beginning
                at 6 months)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are enrolled in the study and randomly assigned to the immediate intervention or the delayed intervention group. Participants in the immediate intervention group will receive the intervention for 6 months with a 6-month and 12-month follow-up starting from day one of enrollment. Participants in the delayed intervention group will receive the intervention beginning 6 months after enrollment with a 6-month and 12-month follow-up starting from day one of enrollment.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of farm shares picked-up
time frame: up to 12 months
description: Number of farm shares picked-up
measure: Overall satisfaction score
time frame: up to 12 months
description: overall satisfaction with the program measured by likelihood of recommending the program to a friend on a 4 point scale 1 = not likely at all, 2 = somewhat likely, 3 = likely 4 = very likely
measure: Health Eating Index
time frame: up to 12 months
description: Diet quality, defined by the Health Eating Index which will be derived from the completion of 2 24-hour dietary recalls
measure: BMI
time frame: up to 12 months
description: The child participant's body mass index
measure: USDA US Household Food Security Survey
time frame: up to 12 months
description: Food Insecurity as measured by an 18-item Self reported concern about being able to afford food or have access to food at the end of a given month. Responses to the questions in the food security survey module are combined into a scale using non-linear statistical methods based on the Rasch measurement model.
measure: Hemoglobin A1c level
time frame: up to 12 months
description: The adult participant's glycemic control (as measured by hemoglobin A1c)
measure: The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale
time frame: up to 12 months
description: Diabetes Self Efficacy as measured by Self reported feelings on one's ability to control and manage their diabetes. 8-item survey, total range from 8 (not at all confident) to 80 (totally confident).
measure: Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky
time frame: up to 12 months
description: Cooking attitudes as measured by self reported attitudes about cooking and the use of the provided fresh fruits and vegetables to provide food to themselves and or their families.
arm group label: Autumn Group
arm group type: Other
description: Intervention Group
arm group label: Spring Group
arm group type: Other
description: Delayed Intervention
intervention type: Other
intervention name: Autumn Group
description: The intervention is participating in a fruit and vegetable farm share for 6 months.
arm group label: Autumn Group
other name: Fresh fruit and vegetable subsidy
intervention type: Other
intervention name: Spring Group
description: The intervention is participating in a fruit and vegetable farm share for 6 months.
arm group label: Spring Group
other name: Fresh fruit and vegetable subsidy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Victoria Mayer, MD, MS
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No