<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/NCT03255304</url>
  </required_header>
  <id_info>
    <org_study_id>PIT_prime</org_study_id>
    <nct_id>NCT03255304</nct_id>
  </id_info>
  <brief_title>Influence of Priming on Goal-directed and Cue-dependent Behavior</brief_title>
  <official_title>Influence of Priming on Goal-directed and Cue-dependent Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      The current proposal aims to investigate implicit and explicit priming paradigms for changing&#xD;
      cue-dependent and goal-directed nutritional behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Food choice and intake is a daily and throughout normal subject. However, for more and more&#xD;
      people eating habits and the question of food choice are of increasing interest and in&#xD;
      several cases even a problem. The prevalence of obesity has tripled in the last decades and&#xD;
      it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail&#xD;
      on the long run, also because people fall back into former unhealthy eating habits. Various&#xD;
      factors influence our daily food choice, not all of which are apparent to ourselves. Thus,&#xD;
      food choice might be goal-directed and therefore conscious and reflective, yet in other&#xD;
      circumstances the choice to eat something specific might be based on cue dependent processes&#xD;
      which are automatic and thus difficult to control. Since a change in eating-behavior and&#xD;
      long-lasting weight loss is most problematic to achieve, the current proposal aims to&#xD;
      investigate implicit and explicit priming paradigms for changing cue-dependent and&#xD;
      goal-directed nutritional behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>behavior</measure>
    <time_frame>pre and post priming (directly before and directly after a 5 minutes priming paradigm)</time_frame>
    <description>change in food choice within a Pavlovian-to-instrumental transfer task (duration of complete protocol about 45 minutes, including priming (5 minutes) and pre and post measurements)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">222</enrollment>
  <condition>Eating Behavior</condition>
  <condition>Habits</condition>
  <arm_group>
    <arm_group_label>health prime</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>palatability prime</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>health mindest</intervention_name>
    <description>groups be confronted with health aspects of food items</description>
    <arm_group_label>health prime</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>palatability mindset</intervention_name>
    <description>groups be confronted with palatability aspects of food items</description>
    <arm_group_label>palatability prime</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently dieting&#xD;
&#xD;
          -  intolerance to provided food&#xD;
&#xD;
          -  cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Tübingen</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Sabine Frank</investigator_full_name>
    <investigator_title>Research Associate</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/NCT03255304
org study id: PIT_prime
nct id: NCT03255304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current proposal aims to investigate implicit and explicit priming paradigms for changing
      cue-dependent and goal-directed nutritional behavior.
Food choice and intake is a daily and throughout normal subject. However, for more and more
      people eating habits and the question of food choice are of increasing interest and in
      several cases even a problem. The prevalence of obesity has tripled in the last decades and
      it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail
      on the long run, also because people fall back into former unhealthy eating habits. Various
      factors influence our daily food choice, not all of which are apparent to ourselves. Thus,
      food choice might be goal-directed and therefore conscious and reflective, yet in other
      circumstances the choice to eat something specific might be based on cue dependent processes
      which are automatic and thus difficult to control. Since a change in eating-behavior and
      long-lasting weight loss is most problematic to achieve, the current proposal aims to
      investigate implicit and explicit priming paradigms for changing cue-dependent and
      goal-directed nutritional behavior.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: behavior
time frame: pre and post priming (directly before and directly after a 5 minutes priming paradigm)
description: change in food choice within a Pavlovian-to-instrumental transfer task (duration of complete protocol about 45 minutes, including priming (5 minutes) and pre and post measurements)
arm group label: health prime
arm group type: Experimental
arm group label: palatability prime
arm group type: Experimental
intervention type: Behavioral
intervention name: health mindest
description: groups be confronted with health aspects of food items
arm group label: health prime
intervention type: Behavioral
intervention name: palatability mindset
description: groups be confronted with palatability aspects of food items
arm group label: palatability prime
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Sabine Frank
investigator title: Research Associate