<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/NCT03756844</url>
  </required_header>
  <id_info>
    <org_study_id>JRCFC Single-Subject</org_study_id>
    <nct_id>NCT03756844</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality</brief_title>
  <official_title>Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Michigan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Cross Blue Shield of Michigan Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western Michigan University</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>
      This single subject study tested the effectiveness of the Just Right Challenge Food Club for&#xD;
      decreasing food selectivity and increasing mealtime qualify for children with developmental&#xD;
      disabilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study used a single subject design to test the effectiveness of the Just Right Challenge&#xD;
      Food Club for decreasing food selectivity and increasing mealtime quality for children with&#xD;
      developmental disabilities. Baseline data was collected during the time that participants&#xD;
      spent on the wait list for treatment. Treatment data was collected each week during treatment&#xD;
      session. This protocol produced a significant change in both the number of foods the children&#xD;
      in the study ate as well as the parents perception of mealtime quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2016</start_date>
  <completion_date type="Actual">December 12, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This was a single-subject (time series design).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>There was no masking. This was a single subject study. Participants allowed us to use their clinical data for research purposes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Food Inventory questionnaire</measure>
    <time_frame>Every week for up to 45 weeks</time_frame>
    <description>Parents marked the foods that their child ate over the past week every week for up to 45 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in About Your Child's Eating questionnaire</measure>
    <time_frame>Up to 45 weeks between pre and post test measures.</time_frame>
    <description>A measure of parent perception of mealtime qualify</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Food Selectivity</condition>
  <arm_group>
    <arm_group_label>Just Right Challenge Food Club Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There was only one arm in this study. All participants received the Just Right Challenge Food Club Protocol and single subject (time series) data was collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Just Right Challenge Food Club</intervention_name>
    <description>Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.</description>
    <arm_group_label>Just Right Challenge Food Club Protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who accepted less than 15 foods as part of their regular diet&#xD;
&#xD;
          -  Children who refused whole food groups&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with life threatening food selectivity per parent report and physician&#xD;
             referral information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Michigan University</investigator_affiliation>
    <investigator_full_name>Michelle A Suarez</investigator_full_name>
    <investigator_title>PhD, OTRL, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Avoidant Restrictive Food Intake Disorder</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/NCT03756844
org study id: JRCFC Single-Subject
nct id: NCT03756844
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This single subject study tested the effectiveness of the Just Right Challenge Food Club for
      decreasing food selectivity and increasing mealtime qualify for children with developmental
      disabilities.
This study used a single subject design to test the effectiveness of the Just Right Challenge
      Food Club for decreasing food selectivity and increasing mealtime quality for children with
      developmental disabilities. Baseline data was collected during the time that participants
      spent on the wait list for treatment. Treatment data was collected each week during treatment
      session. This protocol produced a significant change in both the number of foods the children
      in the study ate as well as the parents perception of mealtime quality.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This was a single-subject (time series design).
primary purpose: Treatment
masking: None (Open Label)
masking description: There was no masking. This was a single subject study. Participants allowed us to use their clinical data for research purposes.
measure: Change in Food Inventory questionnaire
time frame: Every week for up to 45 weeks
description: Parents marked the foods that their child ate over the past week every week for up to 45 weeks
measure: Change in About Your Child's Eating questionnaire
time frame: Up to 45 weeks between pre and post test measures.
description: A measure of parent perception of mealtime qualify
arm group label: Just Right Challenge Food Club Protocol
arm group type: Experimental
description: There was only one arm in this study. All participants received the Just Right Challenge Food Club Protocol and single subject (time series) data was collected.
intervention type: Behavioral
intervention name: Just Right Challenge Food Club
description: Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.
arm group label: Just Right Challenge Food Club Protocol
criteria: 
gender: All
minimum age: 2 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Western Michigan University
investigator full name: Michelle A Suarez
investigator title: PhD, OTRL, Associate Professor
sharing ipd: No