<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/NCT03003923</url>
  </required_header>
  <id_info>
    <org_study_id>Chandani Nekitsing</org_study_id>
    <nct_id>NCT03003923</nct_id>
  </id_info>
  <brief_title>Promoting Vegetable Intake in Preschool Aged Children</brief_title>
  <official_title>A Randomised Control Trial of an Educational and Taste-exposure Intervention to Promote Vegetable Intake in Preschool Aged Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Purely Nutrition Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Economic and Social Research Council, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this cluster randomised control trial is to test the efficacy of a repeated taste&#xD;
      exposure intervention, a nutritional educational intervention and combination of both to&#xD;
      increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to test the efficacy of a repeated taste exposure intervention, a&#xD;
      nutritional educational intervention and combination of both to increase intake of an&#xD;
      unfamiliar vegetable in preschool aged children (aged 3-5 years). In particular the study&#xD;
      will assess whether these strategies are effective to encourage intake of an unfamiliar&#xD;
      vegetable in children who are fussy eaters or going through the food neophobia phase. The&#xD;
      effectiveness of these interventions will also be observed overtime at 3 and 6 months post&#xD;
      intervention.&#xD;
&#xD;
      Nurseries will be randomised into one of four conditions over the 12 week intervention&#xD;
      period; these include educational intervention only, taste exposures only, taste exposures&#xD;
      and educational intervention or no intervention (control group). All children will be offered&#xD;
      an unfamiliar vegetable prior to the intervention and after the intervention to evaluate&#xD;
      changes in intake of the unfamiliar vegetable. The repeated taste exposure groups will be&#xD;
      offered the novel vegetable repeatedly (1 exposure per week) over the 12 week period. For the&#xD;
      educational intervention nursery staff will be advised to deliver two components of an&#xD;
      existing PhunkyFoods educational programme over the same period.&#xD;
&#xD;
      Parents will be asked some general demographic questions, child food behaviour questions and&#xD;
      questions about their feeding practices. Finally nursery staff will be requested to provide&#xD;
      feedback to evaluate intervention feasibility, barriers and efficacy.&#xD;
&#xD;
      It is predicted that children's intake of the unfamiliar vegetable will vary by intervention.&#xD;
      The primary hypothesis to be tested is that children who receive the repeated taste exposures&#xD;
      are more likely to increase their intake of the unfamiliar vegetable compared to those in&#xD;
      educational only or control conditions. The second hypothesis is that repeated taste&#xD;
      exposures will increase intake of an unfamiliar vegetable in fussy eaters more than&#xD;
      education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Intake of an unfamiliar vegetable</measure>
    <time_frame>Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1), Week 36 (Follow up 2)</time_frame>
    <description>Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-ups 3 (week 24) and 6 months (week 36) later. Intake of unfamiliar vegetable will be measured individually and objectively using weight in grams.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intake of usual vegetables</measure>
    <time_frame>Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1)</time_frame>
    <description>Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-up 3 months later (week 24). Intake of usual vegetable will be measured using a Food Frequency Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Food Habits</condition>
  <condition>Food Preferences</condition>
  <condition>Behavior</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Taste Exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will be repeatedly offered the single vegetable which is unfamiliar to them over the 12 week period. Children will be in their natural setting at nursery and will be offered 40g of the vegetable by their usual nursery staff. The vegetable will be weighed before and after using a digital scale by the researcher.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutritional Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nursery staff will be trained by the PhunkyFoods team to deliver the nutritional education programme. Children will be taught Eat Well (learning about different food groups) and Strive for Five (learning about eating fruits and vegetables) components of the PhunkyFoods education programme by their usual nursery staff. Nurseries will be advised to deliver as much as possible of the two components over the 12 week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Taste Exposure and Nutritional Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will be repeatedly offered a single unfamiliar vegetable over the 12 week period as well as receive the PhunkyFoods educational programme (Eat Well and Strive for Five components). Children will be in their natural setting at nursery and will be offered the vegetable and nutritional education by their usual nursery staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children will be offered single unfamiliar vegetable at the beginning, end and at the follow-up. There will be no repeated taste exposure or education during the study phase or follow-up; they will be offered the nutritional education after the study has completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Taste exposure</intervention_name>
    <description>Exposure to the same vegetable</description>
    <arm_group_label>Taste Exposure</arm_group_label>
    <arm_group_label>Taste Exposure and Nutritional Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional education</intervention_name>
    <description>Eat Well and Strive for Five nutritional education</description>
    <arm_group_label>Nutritional Education</arm_group_label>
    <arm_group_label>Taste Exposure and Nutritional Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 to 5 years old&#xD;
&#xD;
          -  Attends nursery on selected test day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Relevant food allergy (mooli / radish)&#xD;
&#xD;
          -  Medical condition which would prevent them from eating the test vegetable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chandani Nekitsing, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Psychology, University of Leeds</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS2 9JT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Chandani Nekitsing</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vegetable intake</keyword>
  <keyword>Taste exposures</keyword>
  <keyword>Educational intervention</keyword>
  <keyword>Preschool children</keyword>
  <keyword>Healthy eating intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03003923
org study id: Chandani Nekitsing
nct id: NCT03003923
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this cluster randomised control trial is to test the efficacy of a repeated taste
      exposure intervention, a nutritional educational intervention and combination of both to
      increase intake of an unfamiliar vegetable in preschool aged children (aged 3-5 years).
The aim of this study is to test the efficacy of a repeated taste exposure intervention, a
      nutritional educational intervention and combination of both to increase intake of an
      unfamiliar vegetable in preschool aged children (aged 3-5 years). In particular the study
      will assess whether these strategies are effective to encourage intake of an unfamiliar
      vegetable in children who are fussy eaters or going through the food neophobia phase. The
      effectiveness of these interventions will also be observed overtime at 3 and 6 months post
      intervention.

      Nurseries will be randomised into one of four conditions over the 12 week intervention
      period; these include educational intervention only, taste exposures only, taste exposures
      and educational intervention or no intervention (control group). All children will be offered
      an unfamiliar vegetable prior to the intervention and after the intervention to evaluate
      changes in intake of the unfamiliar vegetable. The repeated taste exposure groups will be
      offered the novel vegetable repeatedly (1 exposure per week) over the 12 week period. For the
      educational intervention nursery staff will be advised to deliver two components of an
      existing PhunkyFoods educational programme over the same period.

      Parents will be asked some general demographic questions, child food behaviour questions and
      questions about their feeding practices. Finally nursery staff will be requested to provide
      feedback to evaluate intervention feasibility, barriers and efficacy.

      It is predicted that children's intake of the unfamiliar vegetable will vary by intervention.
      The primary hypothesis to be tested is that children who receive the repeated taste exposures
      are more likely to increase their intake of the unfamiliar vegetable compared to those in
      educational only or control conditions. The second hypothesis is that repeated taste
      exposures will increase intake of an unfamiliar vegetable in fussy eaters more than
      education.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Intake of an unfamiliar vegetable
time frame: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1), Week 36 (Follow up 2)
description: Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-ups 3 (week 24) and 6 months (week 36) later. Intake of unfamiliar vegetable will be measured individually and objectively using weight in grams.
measure: Intake of usual vegetables
time frame: Week 0 (Pre Intervention Intake), Week 12 (Post Intake), Week 24 (Follow up 1)
description: Outcome measured at pre intervention (week 0), post intervention (week 12) and at follow-up 3 months later (week 24). Intake of usual vegetable will be measured using a Food Frequency Questionnaire.
arm group label: Taste Exposure
arm group type: Experimental
description: Children will be repeatedly offered the single vegetable which is unfamiliar to them over the 12 week period. Children will be in their natural setting at nursery and will be offered 40g of the vegetable by their usual nursery staff. The vegetable will be weighed before and after using a digital scale by the researcher.
arm group label: Nutritional Education
arm group type: Experimental
description: Nursery staff will be trained by the PhunkyFoods team to deliver the nutritional education programme. Children will be taught Eat Well (learning about different food groups) and Strive for Five (learning about eating fruits and vegetables) components of the PhunkyFoods education programme by their usual nursery staff. Nurseries will be advised to deliver as much as possible of the two components over the 12 week period.
arm group label: Taste Exposure and Nutritional Education
arm group type: Experimental
description: Children will be repeatedly offered a single unfamiliar vegetable over the 12 week period as well as receive the PhunkyFoods educational programme (Eat Well and Strive for Five components). Children will be in their natural setting at nursery and will be offered the vegetable and nutritional education by their usual nursery staff.
arm group label: Control
arm group type: No Intervention
description: Children will be offered single unfamiliar vegetable at the beginning, end and at the follow-up. There will be no repeated taste exposure or education during the study phase or follow-up; they will be offered the nutritional education after the study has completed.
intervention type: Behavioral
intervention name: Taste exposure
description: Exposure to the same vegetable
arm group label: Taste Exposure
arm group label: Taste Exposure and Nutritional Education
intervention type: Behavioral
intervention name: Nutritional education
description: Eat Well and Strive for Five nutritional education
arm group label: Nutritional Education
arm group label: Taste Exposure and Nutritional Education
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chandani Nekitsing, MSc
role: Principal Investigator
affiliation: University of Leeds
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Chandani Nekitsing
investigator title: Principal Investigator
sharing ipd: No