<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/NCT01694043</url>
  </required_header>
  <id_info>
    <org_study_id>8927B</org_study_id>
    <nct_id>NCT01694043</nct_id>
  </id_info>
  <brief_title>The Effect of Watching a Television Show on the Liking of Snack Foods</brief_title>
  <official_title>The Effect of Perceived Healthy and Unhealthy Commercials on Intake of Perceived Healthy and Unhealthy Snack Foods in Normal Weight, College-Aged, Dietary Restrained Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the effect of watching a television show with&#xD;
      healthy food commercials, unhealthy food commercials, or neutral commercials on the&#xD;
      consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1)&#xD;
      Women exposed to a television show with commercials imbedded advertising food will consume&#xD;
      more food than women exposed to a television show with non-food related commercials.&#xD;
&#xD;
      2) Women will consume more food when exposed to a television show with commercials&#xD;
      advertising &quot;unhealthy&quot; food as compared to a television show with commercials advertising&#xD;
      &quot;healthy&quot; food.&#xD;
&#xD;
      3) Women will consume the most food when exposed to a television show with &quot;unhealthy&quot; food&#xD;
      commercials and have &quot;unhealthy&quot; snack foods available to consume.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this investigation is to investigate the effect of television shows with&#xD;
      commercials perceived as advertising healthy foods and television shows with commercials&#xD;
      perceived as advertising unhealthy foods on the intake of either perceived healthy snack&#xD;
      foods or perceived unhealthy snack foods in normal weight, dietary restrained females.&#xD;
&#xD;
      Forty-eight women will participate in this study and will be randomized to one of six&#xD;
      conditions where they will be exposed to a 30-minute television show (Saturday Night Live)&#xD;
      during which they will be given two different pre-measured snack foods to eat. The television&#xD;
      show will have eight commercials imbedded within it. Of the eight commercials, five&#xD;
      commercials will represent the study condition (five advertising healthy food, five&#xD;
      advertising unhealthy food, or five non-food related commercials). The three additional&#xD;
      commercials will advertise neutral products (banks) and will remain the same in each&#xD;
      condition. Snack foods being used in this investigation are red grapes and baby carrots for&#xD;
      the perceived healthy snack foods; and chocolate chip cookies and potato chips for the&#xD;
      perceived unhealthy snack foods. The television commercials representing the unhealthy&#xD;
      category include commercials advertising M&amp;M's candies, Oreo cookies, Cheez-it crackers, 3&#xD;
      Musketeers chocolate bars, and Doritos chips. The television commercials representing the&#xD;
      healthy category include commercials advertising Fiber One bars, Honey Bunches of Oats&#xD;
      cereal, Nature's Path granola, Nestle fruit yogurt, and Musselman's apple sauce. The non-food&#xD;
      related television commercials include commercials advertising All-State car insurance, Geico&#xD;
      car insurance, State Farm car insurance, Travelers car insurance, and Liberty Mutual car&#xD;
      insurance. The three neutral non-food related commercials that will remain the same in each&#xD;
      condition are commercials advertising Fifth Third bank, Ally bank, and Capital One bank.&#xD;
&#xD;
      The specific aims and hypotheses are:&#xD;
&#xD;
        1. Women exposed to a television show with commercials imbedded advertising food will&#xD;
           consume more food than women exposed to a television show with non-food related&#xD;
           commercials.&#xD;
&#xD;
        2. Women will consume more food when exposed to a television show with commercials&#xD;
           advertising &quot;unhealthy&quot; food as compared to a television show with commercials&#xD;
           advertising &quot;healthy&quot; food.&#xD;
&#xD;
        3. Women will consume the most food when exposed to a television show with &quot;unhealthy&quot; food&#xD;
           commercials and have &quot;unhealthy&quot; snack foods available to consume.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total grams of snack foods consumed</measure>
    <time_frame>1 year</time_frame>
    <description>The snack foods that will be used in this investigation are red grapes, baby carrots, Chips Ahoy! chocolate chip cookies (Kraft Foods Global Inc., Northfield, IL), and Lays potato chips (Frito-Lay Inc., Plano, TX). Participants will be provided with 200 grams of two different foods, depending on the condition to which they are randomized. Snack foods provided to participants in each condition will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the session. The weight of the container will also be measured. Total grams of snack food consumed during the session will be determined by subtracting pre- and post-consumption weight of snack food.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measured kilocalories consumed</measure>
    <time_frame>1 year</time_frame>
    <description>The amount of kilocalories consumed in each session will be calculated by determining the weight of food consumed and calculating using food label.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Measure Grams and Kcals of Snack Foods Consumed in Each Condition</condition>
  <arm_group>
    <arm_group_label>Non-Food Related Commercials</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will watch a 30-minute Saturday Night Live television show with non-food related commercials embedded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Food Commercials</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will watch a 30-minute Saturday Night Live television show with healthy food commercials embedded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unhealthy Food Commericlas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will watch a 30-minute Saturday Night Live television show with unhealthy food commercials imbedded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Foods</intervention_name>
    <description>While watching the tv show, participants will receive a healthy snack to eat (grapes and baby carrots).</description>
    <arm_group_label>Healthy Food Commercials</arm_group_label>
    <arm_group_label>Non-Food Related Commercials</arm_group_label>
    <arm_group_label>Unhealthy Food Commericlas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unhealthy Snack Foods</intervention_name>
    <description>While watching the tv show, participants will receive an unhealthy snack to eat (potato chips and chocolate chip cookies).</description>
    <arm_group_label>Healthy Food Commercials</arm_group_label>
    <arm_group_label>Non-Food Related Commercials</arm_group_label>
    <arm_group_label>Unhealthy Food Commericlas</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 30 years&#xD;
&#xD;
          -  have a body mass index between 18.5 and 24.9 kg/m2&#xD;
&#xD;
          -  Be a restrained eater (scoring &gt;12 on Three Factor Eating Questionnaire&#xD;
&#xD;
          -  Report being a non-smoker&#xD;
&#xD;
          -  Perceive foods and commercials used in the study as appropriately classified in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently dieting for weight loss&#xD;
&#xD;
          -  Currently taking any medications that affect appetite or food intake&#xD;
&#xD;
          -  Have a medical condition affecting eating or are currently following a therapeutic&#xD;
             diet&#xD;
&#xD;
          -  Report disliking foods used in the investigation&#xD;
&#xD;
          -  Report having allergies to foods used in the investigation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Tennessee-Knoxville</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996-1920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Hollie Raynor</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01694043
org study id: 8927B
nct id: NCT01694043
lead sponsor: 
has dmc: No
The purpose of the study is to investigate the effect of watching a television show with
      healthy food commercials, unhealthy food commercials, or neutral commercials on the
      consumption of healthy snack foods or unhealthy snack foods. There are three hypotheses: 1)
      Women exposed to a television show with commercials imbedded advertising food will consume
      more food than women exposed to a television show with non-food related commercials.

      2) Women will consume more food when exposed to a television show with commercials
      advertising "unhealthy" food as compared to a television show with commercials advertising
      "healthy" food.

      3) Women will consume the most food when exposed to a television show with "unhealthy" food
      commercials and have "unhealthy" snack foods available to consume.
The objective of this investigation is to investigate the effect of television shows with
      commercials perceived as advertising healthy foods and television shows with commercials
      perceived as advertising unhealthy foods on the intake of either perceived healthy snack
      foods or perceived unhealthy snack foods in normal weight, dietary restrained females.

      Forty-eight women will participate in this study and will be randomized to one of six
      conditions where they will be exposed to a 30-minute television show (Saturday Night Live)
      during which they will be given two different pre-measured snack foods to eat. The television
      show will have eight commercials imbedded within it. Of the eight commercials, five
      commercials will represent the study condition (five advertising healthy food, five
      advertising unhealthy food, or five non-food related commercials). The three additional
      commercials will advertise neutral products (banks) and will remain the same in each
      condition. Snack foods being used in this investigation are red grapes and baby carrots for
      the perceived healthy snack foods; and chocolate chip cookies and potato chips for the
      perceived unhealthy snack foods. The television commercials representing the unhealthy
      category include commercials advertising M&M's candies, Oreo cookies, Cheez-it crackers, 3
      Musketeers chocolate bars, and Doritos chips. The television commercials representing the
      healthy category include commercials advertising Fiber One bars, Honey Bunches of Oats
      cereal, Nature's Path granola, Nestle fruit yogurt, and Musselman's apple sauce. The non-food
      related television commercials include commercials advertising All-State car insurance, Geico
      car insurance, State Farm car insurance, Travelers car insurance, and Liberty Mutual car
      insurance. The three neutral non-food related commercials that will remain the same in each
      condition are commercials advertising Fifth Third bank, Ally bank, and Capital One bank.

      The specific aims and hypotheses are:

        1. Women exposed to a television show with commercials imbedded advertising food will
           consume more food than women exposed to a television show with non-food related
           commercials.

        2. Women will consume more food when exposed to a television show with commercials
           advertising "unhealthy" food as compared to a television show with commercials
           advertising "healthy" food.

        3. Women will consume the most food when exposed to a television show with "unhealthy" food
           commercials and have "unhealthy" snack foods available to consume.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total grams of snack foods consumed
time frame: 1 year
description: The snack foods that will be used in this investigation are red grapes, baby carrots, Chips Ahoy! chocolate chip cookies (Kraft Foods Global Inc., Northfield, IL), and Lays potato chips (Frito-Lay Inc., Plano, TX). Participants will be provided with 200 grams of two different foods, depending on the condition to which they are randomized. Snack foods provided to participants in each condition will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the session. The weight of the container will also be measured. Total grams of snack food consumed during the session will be determined by subtracting pre- and post-consumption weight of snack food.
measure: Measured kilocalories consumed
time frame: 1 year
description: The amount of kilocalories consumed in each session will be calculated by determining the weight of food consumed and calculating using food label.
arm group label: Non-Food Related Commercials
arm group type: Experimental
description: Participants will watch a 30-minute Saturday Night Live television show with non-food related commercials embedded.
arm group label: Healthy Food Commercials
arm group type: Experimental
description: Participants will watch a 30-minute Saturday Night Live television show with healthy food commercials embedded.
arm group label: Unhealthy Food Commericlas
arm group type: Experimental
description: Participants will watch a 30-minute Saturday Night Live television show with unhealthy food commercials imbedded.
intervention type: Other
intervention name: Healthy Foods
description: While watching the tv show, participants will receive a healthy snack to eat (grapes and baby carrots).
arm group label: Healthy Food Commercials
arm group label: Non-Food Related Commercials
arm group label: Unhealthy Food Commericlas
intervention type: Other
intervention name: Unhealthy Snack Foods
description: While watching the tv show, participants will receive an unhealthy snack to eat (potato chips and chocolate chip cookies).
arm group label: Healthy Food Commercials
arm group label: Non-Food Related Commercials
arm group label: Unhealthy Food Commericlas
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Professor