<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/NCT03811210</url>
  </required_header>
  <id_info>
    <org_study_id>Portion size trial</org_study_id>
    <nct_id>NCT03811210</nct_id>
  </id_info>
  <brief_title>Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days</brief_title>
  <official_title>Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Liverpool</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reducing food portion size is a potential strategy to reduce energy intake. However it is&#xD;
      unclear at what point consumers compensate for reductions in portion size by increasing&#xD;
      energy intake from other items. This could result in no overall benefit of reducing food&#xD;
      portion sizes. The investigators tested the hypothesis that reductions to the portion size of&#xD;
      components of a main meal will only result in significant compensatory eating when the&#xD;
      reduced portion size is no longer visually perceived as 'normal'. In a crossover experiment,&#xD;
      participants were served different sized portions during lunch and dinner over 5 days: a&#xD;
      'large-normal', a 'small-normal', and a 'smaller than normal' portion. Intake from all other&#xD;
      meal components consumed in the laboratory were measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">December 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 7, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute compensatory energy intake</measure>
    <time_frame>Immediate (within single meal occasion)</time_frame>
    <description>Energy intake from main meal components that are not varied by portion size</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total meal energy intake</measure>
    <time_frame>Immediate (within single meal occasion)</time_frame>
    <description>Energy intake from all main meal components (including those that are and are not varied by portion size)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total daily energy intake</measure>
    <time_frame>Over 5 x full days</time_frame>
    <description>Energy intake from all foods consumed, including those provided in the laboratory and those self-reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moderate-vigorous physical activity</measure>
    <time_frame>Over 5 x full days</time_frame>
    <description>Moderate-vigorous physical activity (recorded using accelerometer device)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discretionary Leisure-time physical activity</measure>
    <time_frame>Over 5 x full days</time_frame>
    <description>Discretionary Leisure-time physical activity (recorded with self-report measure International Physical Activity Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>Over 5 x full days (measured before and after each meal occasion)</time_frame>
    <description>Hunger and fullness sensations before and after laboratory-based meals (self-reported on visual analog scales anchored at 0 'not at all' to 100 'extremely')</description>
  </secondary_outcome>
  <enrollment type="Actual">39</enrollment>
  <condition>Portion Size</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>portion size</intervention_name>
    <description>Smaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory.&#xD;
Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory.&#xD;
Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing to consume the test foods&#xD;
&#xD;
          -  BMI between 22.5 - 32.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  food allergies, intolerances or specific dietary requirements (including being&#xD;
             vegetarian or vegan)&#xD;
&#xD;
          -  history of eating disorders&#xD;
&#xD;
          -  taking medication which affected appetite&#xD;
&#xD;
          -  participated in a portion size studies in the past 12 months, or in dieting or weight&#xD;
             loss trials in the past 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ashleigh Haynes</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L3 6AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</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>Reader in Psychological Sciences</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for primary outcome measures, demographic variables, and data reported in resulting publication will be made freely available on Open Science Framework</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Study protocol and statistical analysis plan, along with IPD data will be made publicly available on Open Science Framework when results are published</ipd_time_frame>
    <ipd_access_criteria>Data will be freely accessible.</ipd_access_criteria>
  </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/NCT03811210
org study id: Portion size trial
nct id: NCT03811210
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Reducing food portion size is a potential strategy to reduce energy intake. However it is
      unclear at what point consumers compensate for reductions in portion size by increasing
      energy intake from other items. This could result in no overall benefit of reducing food
      portion sizes. The investigators tested the hypothesis that reductions to the portion size of
      components of a main meal will only result in significant compensatory eating when the
      reduced portion size is no longer visually perceived as 'normal'. In a crossover experiment,
      participants were served different sized portions during lunch and dinner over 5 days: a
      'large-normal', a 'small-normal', and a 'smaller than normal' portion. Intake from all other
      meal components consumed in the laboratory were measured.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Acute compensatory energy intake
time frame: Immediate (within single meal occasion)
description: Energy intake from main meal components that are not varied by portion size
measure: Total meal energy intake
time frame: Immediate (within single meal occasion)
description: Energy intake from all main meal components (including those that are and are not varied by portion size)
measure: Total daily energy intake
time frame: Over 5 x full days
description: Energy intake from all foods consumed, including those provided in the laboratory and those self-reported
measure: Moderate-vigorous physical activity
time frame: Over 5 x full days
description: Moderate-vigorous physical activity (recorded using accelerometer device)
measure: Discretionary Leisure-time physical activity
time frame: Over 5 x full days
description: Discretionary Leisure-time physical activity (recorded with self-report measure International Physical Activity Questionnaire)
measure: Appetite
time frame: Over 5 x full days (measured before and after each meal occasion)
description: Hunger and fullness sensations before and after laboratory-based meals (self-reported on visual analog scales anchored at 0 'not at all' to 100 'extremely')
intervention type: Behavioral
intervention name: portion size
description: Smaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory.
Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory.
Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Liverpool
investigator full name: Eric Robinson
investigator title: Reader in Psychological Sciences
sharing ipd: Yes
ipd description: IPD for primary outcome measures, demographic variables, and data reported in resulting publication will be made freely available on Open Science Framework
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Study protocol and statistical analysis plan, along with IPD data will be made publicly available on Open Science Framework when results are published
ipd access criteria: Data will be freely accessible.