<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/NCT01710124</url>
  </required_header>
  <id_info>
    <org_study_id>816224</org_study_id>
    <nct_id>NCT01710124</nct_id>
  </id_info>
  <brief_title>Buy 1 Get 1: Role of Grocery Coupons in Promoting Obesogenic Home Food Environments and Eating Behaviors</brief_title>
  <official_title>Buy 1 Get 1: Role of Grocery Coupons in Promoting Obesogenic Home Food</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of overweight and obesity among older adults has reached an all-time high,&#xD;
      which puts this age group at high risk for associated comorbidities such as type 2 diabetes,&#xD;
      cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and&#xD;
      economic uncertainty, many middle-aged and older Americans tried to save on their food&#xD;
      purchases during the 2007-2009 recession. Grocery coupons, available through newspapers,&#xD;
      mail, and increasingly online, are one of several promotional tools that supermarkets and&#xD;
      warehouse clubs use to promote sales. It is estimated that nationally 27% of households are&#xD;
      frequent grocery coupon users who shop at a variety of retailers. Despite the increasing&#xD;
      popularity of grocery coupons, little is known about the extent to which they may promote&#xD;
      obesogenic home food environments and eating behaviors. Many coupons advertise the purchase&#xD;
      of large quantities of prepackaged and processed foods and often reward shoppers by adding&#xD;
      'free' products if they purchase certain quantities. Availability and easy accessibility of&#xD;
      large portions of energy dense foods in the home has been shown to promote increased intake.&#xD;
      The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary&#xD;
      intake, weight status, and home food availability among middle-aged and older adults. A&#xD;
      second aim of this study is to test, in a randomized-controlled trial, the effects of&#xD;
      incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in&#xD;
      dietary intake, body mass index/waist circumference, home food availability, and grocery&#xD;
      coupon use among frequent coupon users and non-coupon users.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>Change from baseline to month 3 (end of intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Change from baseline to month 3 (end of intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Change from baseline to month 3 (end of intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of healthy and less healthy foods in the home</measure>
    <time_frame>Change from baseline to month 3 (end of intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive financial incentives for using grocery coupons to purchase healthy foods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No incentive</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in this group will receive no financial incentives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Financial incentives</intervention_name>
    <arm_group_label>Incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 - 70 years of age&#xD;
&#xD;
          -  frequent grocery coupon users&#xD;
&#xD;
          -  non-coupon users&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dieting&#xD;
&#xD;
          -  medication use or medical conditions known to affect food intake and weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>June 9, 2015</last_update_submitted>
  <last_update_submitted_qc>June 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>grocery purchases</keyword>
  <keyword>financial incentives</keyword>
  <keyword>obesogenic home food environment</keyword>
  <!-- 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/NCT01710124
org study id: 816224
nct id: NCT01710124
lead sponsor: 
has dmc: No
The prevalence of overweight and obesity among older adults has reached an all-time high,
      which puts this age group at high risk for associated comorbidities such as type 2 diabetes,
      cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and
      economic uncertainty, many middle-aged and older Americans tried to save on their food
      purchases during the 2007-2009 recession. Grocery coupons, available through newspapers,
      mail, and increasingly online, are one of several promotional tools that supermarkets and
      warehouse clubs use to promote sales. It is estimated that nationally 27% of households are
      frequent grocery coupon users who shop at a variety of retailers. Despite the increasing
      popularity of grocery coupons, little is known about the extent to which they may promote
      obesogenic home food environments and eating behaviors. Many coupons advertise the purchase
      of large quantities of prepackaged and processed foods and often reward shoppers by adding
      'free' products if they purchase certain quantities. Availability and easy accessibility of
      large portions of energy dense foods in the home has been shown to promote increased intake.
      The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary
      intake, weight status, and home food availability among middle-aged and older adults. A
      second aim of this study is to test, in a randomized-controlled trial, the effects of
      incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in
      dietary intake, body mass index/waist circumference, home food availability, and grocery
      coupon use among frequent coupon users and non-coupon users.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dietary intake
time frame: Change from baseline to month 3 (end of intervention)
measure: Body mass index
time frame: Change from baseline to month 3 (end of intervention)
measure: Waist circumference
time frame: Change from baseline to month 3 (end of intervention)
measure: Number of healthy and less healthy foods in the home
time frame: Change from baseline to month 3 (end of intervention)
arm group label: Incentive
arm group type: Experimental
description: Subjects in this group will receive financial incentives for using grocery coupons to purchase healthy foods.
arm group label: No incentive
arm group type: No Intervention
description: Subjects in this group will receive no financial incentives.
intervention type: Other
intervention name: Financial incentives
arm group label: Incentive
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor