<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/NCT03296878</url>
  </required_header>
  <id_info>
    <org_study_id>GFHNRC151</org_study_id>
    <nct_id>NCT03296878</nct_id>
  </id_info>
  <brief_title>Food-for-Families: Experimental Grocery Store Study</brief_title>
  <official_title>Food-for-Families: Relationship Between Income, Obesity, and Food Purchasing Using an Experimental Grocery Store Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Grand Forks Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Grand Forks Human Nutrition Research Center</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>
      This is a study about how the price of foods affects buying choices at the grocery store. The&#xD;
      price of foods can have a big impact on what people choose to buy and prices change over&#xD;
      time. This study is being done to see how changes in food prices affect what mothers choose&#xD;
      for their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is well known that the price of a given food affects the amount of that item individuals&#xD;
      will purchase. Yet little is known about how specific groups, such as obese/overweight&#xD;
      individuals and those with lower incomes, change their food purchasing decisions depending on&#xD;
      food price changes. Evidence shows that these groups have lower quality diets and worse&#xD;
      health outcomes than their normal weight and higher income counterparts. Therefore, it is&#xD;
      important to gain a better understanding of how food price changes affect purchasing&#xD;
      decisions among these population groups in order to develop targeted nutrition interventions&#xD;
      to improve their diet quality. To investigate this, the researchers will create a&#xD;
      laboratory-based grocery store, in which pictures of foods will be used in lieu of actual&#xD;
      foods. Food prices will be indicated on each picture. The participants will be given play&#xD;
      money and a budget, and asked to &quot;purchase&quot; foods in the mock grocery store. The price of&#xD;
      foods will be changed throughout the study to investigate how participants change their&#xD;
      purchasing decisions based on these price changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 29, 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>Factorial Assignment</intervention_model>
    <intervention_model_description>This study will utilize a three factor design, with one between-subject factor and two within-subject factors. The between-subject factor is participation in a federal food assistance program. The within-subject factors are price change condition and price change scenario.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Price elasticity of eggs</measure>
    <time_frame>Baseline</time_frame>
    <description>Percent change in the amount of eggs purchased (gram weight) for every percent change in the price of a given food.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutrient density of purchased foods</measure>
    <time_frame>Baseline</time_frame>
    <description>Ratio of low nutrient-dense food purchases to high nutrient-dense food purchases</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Own-Price Elasticity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The price of eggs will vary (own-price elasticity) while the price of other foods in the &quot;mock&quot; grocery store will remain constant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-Price Elasticity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The eggs will remain constant while the price of other foods in the &quot;mock&quot; grocery store will vary (cross-price elasticity).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Own-Price Elasticity</intervention_name>
    <description>The price of eggs will be 75%, 100%, or 125% of the reference price, but the price of other foods will remain the same.</description>
    <arm_group_label>Own-Price Elasticity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cross-Price Elasticity</intervention_name>
    <description>The price of eggs will remain the same, but the price of other foods will be 75%, 100%, or 125% of the reference price.</description>
    <arm_group_label>Cross-Price Elasticity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have at least one child up to 18 years of age residing in the household&#xD;
&#xD;
          -  Primary grocery shopper for the household&#xD;
&#xD;
          -  No health conditions or food practices that substantially limit food choice&#xD;
&#xD;
          -  Not currently pregnant&#xD;
&#xD;
          -  Consent to the study design&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Not a mother, or children not living with subject in their household&#xD;
&#xD;
          -  No children below the age of 18 years of age&#xD;
&#xD;
          -  Not the primary grocery shopper for their household&#xD;
&#xD;
          -  Health conditions or food practices that substantially limit food choice&#xD;
&#xD;
          -  Currently pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>James Roemmich, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA Grand Forks Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA Grand Forks Human Nutrition Research Center</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>low income</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <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/NCT03296878
org study id: GFHNRC151
nct id: NCT03296878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study about how the price of foods affects buying choices at the grocery store. The
      price of foods can have a big impact on what people choose to buy and prices change over
      time. This study is being done to see how changes in food prices affect what mothers choose
      for their families.
It is well known that the price of a given food affects the amount of that item individuals
      will purchase. Yet little is known about how specific groups, such as obese/overweight
      individuals and those with lower incomes, change their food purchasing decisions depending on
      food price changes. Evidence shows that these groups have lower quality diets and worse
      health outcomes than their normal weight and higher income counterparts. Therefore, it is
      important to gain a better understanding of how food price changes affect purchasing
      decisions among these population groups in order to develop targeted nutrition interventions
      to improve their diet quality. To investigate this, the researchers will create a
      laboratory-based grocery store, in which pictures of foods will be used in lieu of actual
      foods. Food prices will be indicated on each picture. The participants will be given play
      money and a budget, and asked to "purchase" foods in the mock grocery store. The price of
      foods will be changed throughout the study to investigate how participants change their
      purchasing decisions based on these price changes.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: This study will utilize a three factor design, with one between-subject factor and two within-subject factors. The between-subject factor is participation in a federal food assistance program. The within-subject factors are price change condition and price change scenario.
primary purpose: Other
masking: None (Open Label)
measure: Price elasticity of eggs
time frame: Baseline
description: Percent change in the amount of eggs purchased (gram weight) for every percent change in the price of a given food.
measure: Nutrient density of purchased foods
time frame: Baseline
description: Ratio of low nutrient-dense food purchases to high nutrient-dense food purchases
arm group label: Own-Price Elasticity
arm group type: Other
description: The price of eggs will vary (own-price elasticity) while the price of other foods in the "mock" grocery store will remain constant.
arm group label: Cross-Price Elasticity
arm group type: Other
description: The eggs will remain constant while the price of other foods in the "mock" grocery store will vary (cross-price elasticity).
intervention type: Other
intervention name: Own-Price Elasticity
description: The price of eggs will be 75%, 100%, or 125% of the reference price, but the price of other foods will remain the same.
arm group label: Own-Price Elasticity
intervention type: Other
intervention name: Cross-Price Elasticity
description: The price of eggs will remain the same, but the price of other foods will be 75%, 100%, or 125% of the reference price.
arm group label: Cross-Price Elasticity
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Roemmich, PhD
role: Principal Investigator
affiliation: USDA Grand Forks Human Nutrition Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No