<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/NCT03248583</url>
  </required_header>
  <id_info>
    <org_study_id>16-E-005-01</org_study_id>
    <nct_id>NCT03248583</nct_id>
  </id_info>
  <brief_title>Decision-Making Processes While Online Grocery Shopping</brief_title>
  <official_title>Decision-Making Processes While Online Grocery Shopping</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Albany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University at Albany</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>
      Individuals living with food insecurity are disproportionately affected by overweight and&#xD;
      obesity and associated chronic health problems. There remains a lack of sustainable and&#xD;
      scalable interventions targeting widespread barriers to access to healthy foods in this&#xD;
      population to increase the nutritional quality of foods purchased for preparation and&#xD;
      consumption at home.&#xD;
&#xD;
      This randomized controlled proof-of-principle trial was designed to examine the feasibility&#xD;
      and initial efficacy of a &quot;default option&quot; in enhancing the nutritional quality of groceries&#xD;
      selected via the online shopping service of a local grocery store under conditions that mimic&#xD;
      the financial constraints typical of individuals living with food insecurity.&#xD;
&#xD;
      In behavioral economics, the &quot;default option&quot; refers to the option a consumer selects if no&#xD;
      active choice is made. The notion of the default option is based on the concept of&#xD;
      &quot;asymmetrical&quot; or &quot;libertarian paternalism,&quot; which seeks to subtly shift consumer behavior in&#xD;
      a manner that promotes welfare, but without overtly interfering with the individual's freedom&#xD;
      to choose.&#xD;
&#xD;
      It was hypothesized that the &quot;default&quot; option effectively increases the nutritional quality&#xD;
      of foods purchased online, compared to monetary incentives and psychoeducation about&#xD;
      nutrition.&#xD;
&#xD;
      Female undergraduate students (n = 60) selected food for one week using the online shopping&#xD;
      service of a local grocery store with a budget corresponding to maximum weekly Supplemental&#xD;
      Nutrition Assistance Program (SNAP) benefits. Before completing the task again, participants&#xD;
      were randomized to: (1) a small monetary &quot;incentive&quot; for selecting groceries that meet&#xD;
      nutritional guidelines (n = 17), (2) an &quot;educational&quot; brochure (n = 24), or (3) a &quot;default&quot;&#xD;
      pre-filled online shopping cart containing a nutritionally balanced selection of groceries to&#xD;
      which they could freely make changes (n = 18).&#xD;
&#xD;
      Primary outcome measures capture the nutritional quality of groceries selected/ purchased.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2016</start_date>
  <completion_date type="Actual">September 29, 2016</completion_date>
  <primary_completion_date type="Actual">September 29, 2016</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nutritional quality</measure>
    <time_frame>Single laboratory visit, &lt;1.5 hours</time_frame>
    <description>The Thrifty Food Plan Calculator (TFPC) was used to quantify the nutritional quality of groceries selected by study participants. The TFPC was developed using U.S. Department of Agriculture nutrition and consumption data and is designed to have users input information about the relative amount of money spent on various categories of food and provides comprehensive information on caloric, macro-, and micronutrient content of the foods selected based on participant age and gender.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Nutrition Poor</condition>
  <arm_group>
    <arm_group_label>Default</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Default option</intervention_name>
    <description>The &quot;default option&quot; is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g. opt-out 401K plans, which significantly increase enrollment, compared to active sign up).&#xD;
Participants in the default condition were presented with a pre-filled online shopping cart containing a combination of groceries that meet macro- and micronutrient requirements for their gender and age, and told that they are free to delete, add, and exchange any item they wish to finalize their selections.</description>
    <arm_group_label>Default</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>Participants in the psychoeducation condition were instructed to read a brief psychoeducational brochure adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance (&quot;Eat Smart New York&quot;).</description>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incentive</intervention_name>
    <description>Participants in the incentive condition were informed that they will receive a gift card to a major retailer of their choice if they select groceries that meet recommended nutritional guidelines for macro- and micronutrient requirements. Participants were given examples of macro- and micronutrients to ensure that the instructions were clear.</description>
    <arm_group_label>Incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 or older&#xD;
&#xD;
          -  fluent in written and spoken English&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant dietary restrictions (i.e., meat avoidance, food allergies, religious&#xD;
             dietary restrictions, etc.)&#xD;
&#xD;
          -  likely presence of current eating disorder diagnosis (score &gt;/= 2 on SCOFF screening&#xD;
             measure)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant eligibility was based in part on self-representation of gender identity as female.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University at Albany</investigator_affiliation>
    <investigator_full_name>Julia Hormes</investigator_full_name>
    <investigator_title>Assistant Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>Proof-of-principle</keyword>
  <keyword>Feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03248583
org study id: 16-E-005-01
nct id: NCT03248583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Individuals living with food insecurity are disproportionately affected by overweight and
      obesity and associated chronic health problems. There remains a lack of sustainable and
      scalable interventions targeting widespread barriers to access to healthy foods in this
      population to increase the nutritional quality of foods purchased for preparation and
      consumption at home.

      This randomized controlled proof-of-principle trial was designed to examine the feasibility
      and initial efficacy of a "default option" in enhancing the nutritional quality of groceries
      selected via the online shopping service of a local grocery store under conditions that mimic
      the financial constraints typical of individuals living with food insecurity.

      In behavioral economics, the "default option" refers to the option a consumer selects if no
      active choice is made. The notion of the default option is based on the concept of
      "asymmetrical" or "libertarian paternalism," which seeks to subtly shift consumer behavior in
      a manner that promotes welfare, but without overtly interfering with the individual's freedom
      to choose.

      It was hypothesized that the "default" option effectively increases the nutritional quality
      of foods purchased online, compared to monetary incentives and psychoeducation about
      nutrition.

      Female undergraduate students (n = 60) selected food for one week using the online shopping
      service of a local grocery store with a budget corresponding to maximum weekly Supplemental
      Nutrition Assistance Program (SNAP) benefits. Before completing the task again, participants
      were randomized to: (1) a small monetary "incentive" for selecting groceries that meet
      nutritional guidelines (n = 17), (2) an "educational" brochure (n = 24), or (3) a "default"
      pre-filled online shopping cart containing a nutritionally balanced selection of groceries to
      which they could freely make changes (n = 18).

      Primary outcome measures capture the nutritional quality of groceries selected/ purchased.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Nutritional quality
time frame: Single laboratory visit, <1.5 hours
description: The Thrifty Food Plan Calculator (TFPC) was used to quantify the nutritional quality of groceries selected by study participants. The TFPC was developed using U.S. Department of Agriculture nutrition and consumption data and is designed to have users input information about the relative amount of money spent on various categories of food and provides comprehensive information on caloric, macro-, and micronutrient content of the foods selected based on participant age and gender.
arm group label: Default
arm group type: Experimental
arm group label: Psychoeducation
arm group type: Active Comparator
arm group label: Incentive
arm group type: Active Comparator
intervention type: Other
intervention name: Default option
description: The "default option" is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g. opt-out 401K plans, which significantly increase enrollment, compared to active sign up).
Participants in the default condition were presented with a pre-filled online shopping cart containing a combination of groceries that meet macro- and micronutrient requirements for their gender and age, and told that they are free to delete, add, and exchange any item they wish to finalize their selections.
arm group label: Default
intervention type: Other
intervention name: Psychoeducation
description: Participants in the psychoeducation condition were instructed to read a brief psychoeducational brochure adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance ("Eat Smart New York").
arm group label: Psychoeducation
intervention type: Other
intervention name: Incentive
description: Participants in the incentive condition were informed that they will receive a gift card to a major retailer of their choice if they select groceries that meet recommended nutritional guidelines for macro- and micronutrient requirements. Participants were given examples of macro- and micronutrients to ensure that the instructions were clear.
arm group label: Incentive
criteria: 
gender: Female
gender based: Yes
gender description: Participant eligibility was based in part on self-representation of gender identity as female.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University at Albany
investigator full name: Julia Hormes
investigator title: Assistant Professor of Psychology
mesh term: Malnutrition
sharing ipd: Undecided