<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/NCT03241576</url>
  </required_header>
  <id_info>
    <org_study_id>463882A</org_study_id>
    <nct_id>NCT03241576</nct_id>
  </id_info>
  <brief_title>Provision of Small vs. Large Portion Sizes and Later Food Intake</brief_title>
  <official_title>Provision of Small vs. Large Portion Sizes and Later Self-selected Food Intake: 3 Experimental Laboratory Studies in UK Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liverpool</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>
      In 3 laboratory experiments the effect that receiving a small vs. large portion size of food&#xD;
      has on later intake of that food was examined&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Historical increases in the size of commercially available food products have been linked to&#xD;
      the emergence of a worldwide obesity crisis. Although the acute effect portion size has on&#xD;
      food intake is well established, the effect that exposure to smaller portion sizes has on&#xD;
      future portion size selection is yet to be examined.We tested whether reducing a food portion&#xD;
      size may 'renormalize' perceptions of what constitutes a normal amount of food to eat and&#xD;
      result in people selecting and consuming smaller portions of that food in future. Across&#xD;
      three experiments participants were served a large or smaller portion of food. In experiments&#xD;
      1-2, twenty four hours later participants freely selected and consumed a portion of that&#xD;
      food. In experiment 3, one week later participants reported on their preferred portion size&#xD;
      of that food.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Later food intake (24 hour)</measure>
    <time_frame>Measured 24 hours after random allocation (experiments 1 and 2)</time_frame>
    <description>Amount of the lunchtime food later chosen and consumed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Later food intake (7 days)</measure>
    <time_frame>Measured 7 days after allocation (experiment 3)</time_frame>
    <description>Amount of the lunchtime food later chosen and consumed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">307</enrollment>
  <condition>Eating Behavior</condition>
  <arm_group>
    <arm_group_label>Small portion size provision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm are served a small serving of a lunchtime food to eat (session 1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Large portion size provision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm are served a large serving of a lunchtime food to eat (session 1).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Small portion size provision</intervention_name>
    <description>The intervention is the small meal size participants are provided with during a lunchtime session in the laboratory.</description>
    <arm_group_label>Small portion size provision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Large portion size provision</intervention_name>
    <description>The intervention is the large meal size participants are provided with during a lunchtime session in the laboratory.</description>
    <arm_group_label>Large portion size provision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of food allergy, eating disorder or currently dieting to lose weight&#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>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liverpool</investigator_affiliation>
    <investigator_full_name>Eric Robinson</investigator_full_name>
    <investigator_title>Senior Lecturer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Open science framework</ipd_description>
    <ipd_time_frame>From Publication onwards</ipd_time_frame>
    <ipd_access_criteria>Openly available to all</ipd_access_criteria>
    <ipd_url>https://osf.io/agk2d/</ipd_url>
  </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/NCT03241576
org study id: 463882A
nct id: NCT03241576
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In 3 laboratory experiments the effect that receiving a small vs. large portion size of food
      has on later intake of that food was examined
Historical increases in the size of commercially available food products have been linked to
      the emergence of a worldwide obesity crisis. Although the acute effect portion size has on
      food intake is well established, the effect that exposure to smaller portion sizes has on
      future portion size selection is yet to be examined.We tested whether reducing a food portion
      size may 'renormalize' perceptions of what constitutes a normal amount of food to eat and
      result in people selecting and consuming smaller portions of that food in future. Across
      three experiments participants were served a large or smaller portion of food. In experiments
      1-2, twenty four hours later participants freely selected and consumed a portion of that
      food. In experiment 3, one week later participants reported on their preferred portion size
      of that food.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Later food intake (24 hour)
time frame: Measured 24 hours after random allocation (experiments 1 and 2)
description: Amount of the lunchtime food later chosen and consumed
measure: Later food intake (7 days)
time frame: Measured 7 days after allocation (experiment 3)
description: Amount of the lunchtime food later chosen and consumed
arm group label: Small portion size provision
arm group type: Experimental
description: Participants in this arm are served a small serving of a lunchtime food to eat (session 1).
arm group label: Large portion size provision
arm group type: Active Comparator
description: Participants in this arm are served a large serving of a lunchtime food to eat (session 1).
intervention type: Behavioral
intervention name: Small portion size provision
description: The intervention is the small meal size participants are provided with during a lunchtime session in the laboratory.
arm group label: Small portion size provision
intervention type: Behavioral
intervention name: Large portion size provision
description: The intervention is the large meal size participants are provided with during a lunchtime session in the laboratory.
arm group label: Large portion size provision
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Liverpool
investigator full name: Eric Robinson
investigator title: Senior Lecturer
sharing ipd: Yes
ipd description: Open science framework
ipd time frame: From Publication onwards
ipd access criteria: Openly available to all
ipd url: https://osf.io/agk2d/