<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/NCT03277040</url>
  </required_header>
  <id_info>
    <org_study_id>827780</org_study_id>
    <nct_id>NCT03277040</nct_id>
  </id_info>
  <brief_title>Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives</brief_title>
  <official_title>DEAL Trial: Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      Food is widely understood as a cornerstone of health, however multiple barriers stand between&#xD;
      well-intentioned, well-informed consumers and the adoption of healthier dietary practices.&#xD;
      This mixed-methods randomized controlled trial (RCT) will measure the impact of offering a&#xD;
      Community Sustained Agriculture (CSA) share as an employee benefit on household food&#xD;
      environments (diets), eating behaviors, and lifestyles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: We will test a strategy to increase frequency of cooking meals at home and consumption&#xD;
      of healthful, fresh foods by providing study participants with a CSA membership.&#xD;
&#xD;
      Study design: This is a mixed method randomized controlled trial, with survey, home-food&#xD;
      audit, and interview components.&#xD;
&#xD;
      Hypothesis: The intervention group who received a CSA membership as an employee benefit will&#xD;
      prepare more meals at home and consume more healthful, fresh foods compared to the control&#xD;
      group (no CSA participation).&#xD;
&#xD;
      Using both qualitative and quantitative assessments, outcomes will be measured using 3&#xD;
      primary measures:&#xD;
&#xD;
        1. Home food audits at baseline and at week 8 of the intervention. A random selection of&#xD;
           participants will have home-food audits completed by members of the research team -&#xD;
           those not randomly selected will complete the home-food audit themselves.&#xD;
&#xD;
        2. Self-administered surveys, including food frequency questionnaires, at baseline, week 8,&#xD;
           and week 16.&#xD;
&#xD;
        3. Randomly selected participants will be asked to participate in qualitative interviews at&#xD;
           the close of the 16-week intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 10, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantity of meals prepared and consumed at home.</measure>
    <time_frame>16 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported satisfaction with employee benefits</measure>
    <time_frame>16 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent planning meals</measure>
    <time_frame>16 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent preparing meals</measure>
    <time_frame>16 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress regarding food shopping, meal planning, and meal preparation</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Perceived stress regarding food shopping, meal planning, and meal preparation, assessed during follow-up qualitative interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress regarding food shopping, meal planning, and meal preparation</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Perceived stress regarding food shopping, meal planning, and meal preparation, measured comparing baseline and follow-up surveys using likert scale questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge and self-efficacy regarding healthy food preparation</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Knowledge and self-efficacy regarding healthy food preparation, assessed during follow-up qualitative interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge and self-efficacy regarding healthy food preparation</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Knowledge and self-efficacy regarding healthy food preparation, measured comparing baseline and follow-up surveys using likert scale questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Diet Habit</condition>
  <condition>Obesity</condition>
  <condition>Food Habits</condition>
  <arm_group>
    <arm_group_label>Intervention (CSA membership)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Employees will gain CSA membership - they will receive bi-weekly deliveries of fresh fruits and vegetables to a central location near their place of employment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (no CSA membership)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care, usual employee benefits. Employees do not gain CSA membership.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CSA membership</intervention_name>
    <description>Bi-weekly fresh food delivery</description>
    <arm_group_label>Intervention (CSA membership)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who are non-faculty employees at the University of Pennsylvania and&#xD;
             University of Pennsylvania Health System.&#xD;
&#xD;
          -  Individuals who score below the median (50th percentile) on dinners prepared at home&#xD;
             on screening survey.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are under the age of 18.&#xD;
&#xD;
          -  Individuals who are already have a CSA membership.&#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 Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Carolyn Cannuscio</investigator_full_name>
    <investigator_title>Assistant Professor of Family Medicine and Community Health</investigator_title>
  </responsible_party>
  <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/NCT03277040
org study id: 827780
nct id: NCT03277040
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Food is widely understood as a cornerstone of health, however multiple barriers stand between
      well-intentioned, well-informed consumers and the adoption of healthier dietary practices.
      This mixed-methods randomized controlled trial (RCT) will measure the impact of offering a
      Community Sustained Agriculture (CSA) share as an employee benefit on household food
      environments (diets), eating behaviors, and lifestyles.
Aim: We will test a strategy to increase frequency of cooking meals at home and consumption
      of healthful, fresh foods by providing study participants with a CSA membership.

      Study design: This is a mixed method randomized controlled trial, with survey, home-food
      audit, and interview components.

      Hypothesis: The intervention group who received a CSA membership as an employee benefit will
      prepare more meals at home and consume more healthful, fresh foods compared to the control
      group (no CSA participation).

      Using both qualitative and quantitative assessments, outcomes will be measured using 3
      primary measures:

        1. Home food audits at baseline and at week 8 of the intervention. A random selection of
           participants will have home-food audits completed by members of the research team -
           those not randomly selected will complete the home-food audit themselves.

        2. Self-administered surveys, including food frequency questionnaires, at baseline, week 8,
           and week 16.

        3. Randomly selected participants will be asked to participate in qualitative interviews at
           the close of the 16-week intervention period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Quantity of meals prepared and consumed at home.
time frame: 16 Weeks
measure: Self-reported satisfaction with employee benefits
time frame: 16 Weeks
measure: Time spent planning meals
time frame: 16 Weeks
measure: Time spent preparing meals
time frame: 16 Weeks
measure: Perceived stress regarding food shopping, meal planning, and meal preparation
time frame: 16 Weeks
description: Perceived stress regarding food shopping, meal planning, and meal preparation, assessed during follow-up qualitative interviews
measure: Perceived stress regarding food shopping, meal planning, and meal preparation
time frame: 16 Weeks
description: Perceived stress regarding food shopping, meal planning, and meal preparation, measured comparing baseline and follow-up surveys using likert scale questions
measure: Knowledge and self-efficacy regarding healthy food preparation
time frame: 16 Weeks
description: Knowledge and self-efficacy regarding healthy food preparation, assessed during follow-up qualitative interviews
measure: Knowledge and self-efficacy regarding healthy food preparation
time frame: 16 Weeks
description: Knowledge and self-efficacy regarding healthy food preparation, measured comparing baseline and follow-up surveys using likert scale questions
arm group label: Intervention (CSA membership)
arm group type: Experimental
description: Employees will gain CSA membership - they will receive bi-weekly deliveries of fresh fruits and vegetables to a central location near their place of employment.
arm group label: Control (no CSA membership)
arm group type: No Intervention
description: Usual care, usual employee benefits. Employees do not gain CSA membership.
intervention type: Other
intervention name: CSA membership
description: Bi-weekly fresh food delivery
arm group label: Intervention (CSA membership)
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 Pennsylvania
investigator full name: Carolyn Cannuscio
investigator title: Assistant Professor of Family Medicine and Community Health
sharing ipd: No