xml: <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/NCT05984043</url>
    </required_header>
    <id_info>
      <org_study_id>5P30DK048520-29</org_study_id>
      <nct_id>NCT05984043</nct_id>
    </id_info>
    <brief_title>Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences</brief_title>
    <official_title>Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Colorado State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Children's Hospital Colorado</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Colorado State 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>
        Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18&#xD;
        years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing&#xD;
        adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be&#xD;
        due to dysregulation in stress-related physiology and engagement in stress-related behaviors.&#xD;
        While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care&#xD;
        lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate&#xD;
        trauma-informed care, including assessment and therapeutic attention to effects of ACEs.&#xD;
        Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body&#xD;
        intervention targeting the stress physiology that can be dysregulated in adolescents with&#xD;
        ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback&#xD;
        protocol for 12-17-year-olds with BMI&gt;85th percentile and ACEs. First (Phase 1), we will&#xD;
        iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents&#xD;
        with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to&#xD;
        hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will&#xD;
        conduct a randomized waitlist-controlled pilot study of n=30 adolescents with&#xD;
        overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe&#xD;
        changes in theorized targets of biofeedback (Aim 3).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Facilitator Protocol</measure>
      <time_frame>Year 1</time_frame>
      <description>4-session biofeedback facilitator protocol</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility/Acceptability</measure>
      <time_frame>Year 1</time_frame>
      <description>Protocol implementation will be feasible in terms of recruitment (≥60% eligible enroll), intervention adherence (≥80% will receive &gt;80% dosage), baseline/post-treatment assessment adherence (&lt;20% missing data), and post-treatment retention (≥80%). Biofeedback will be acceptable based on session likeability ratings (80% &gt;4:5) and qualitative themes assessed by interview indicative of likeability/benefit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stress Physiology</measure>
      <time_frame>Year 2</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Stress Eating</measure>
      <time_frame>Year 2</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Inflammatory Biomarkers</measure>
      <time_frame>Year 2</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin Sensitivity</measure>
      <time_frame>Year 2</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Obesity, Adolescent</condition>
    <arm_group>
      <arm_group_label>Biofeedback</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Biofeedback</intervention_name>
      <description>Heart-rate Variability Biofeedback</description>
      <arm_group_label>Biofeedback</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Waitlist</intervention_name>
      <description>Waitlist control group</description>
      <arm_group_label>Waitlist</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Four or more ACEs&#xD;
  &#xD;
            -  BMI at or above the 85th percentile;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major renal, hepatic, endocrinologic, rheumatologic, cardiac, or pulmonary medical&#xD;
               problem likely to affect mood or weight&#xD;
  &#xD;
            -  Medications affecting mood or weight (e.g. anti-anxiety/depressants/psychotics,&#xD;
               stimulants, mood stabilizers, insulin sensitizers, weight loss)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Elizabeth B Ruzicka, PhD</last_name>
      <phone>7207770816</phone>
      <email>elizabeth.ruzicka@childrenscolorado.org</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Colorado State University</investigator_affiliation>
      <investigator_full_name>Elizabeth Ruzicka</investigator_full_name>
      <investigator_title>Postdoctoral Fellow</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984043
  org study id: 5P30DK048520-29
  nct id: NCT05984043
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18
        years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing
        adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be
        due to dysregulation in stress-related physiology and engagement in stress-related behaviors.
        While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care
        lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate
        trauma-informed care, including assessment and therapeutic attention to effects of ACEs.
        Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body
        intervention targeting the stress physiology that can be dysregulated in adolescents with
        ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback
        protocol for 12-17-year-olds with BMI>85th percentile and ACEs. First (Phase 1), we will
        iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents
        with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to
        hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will
        conduct a randomized waitlist-controlled pilot study of n=30 adolescents with
        overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe
        changes in theorized targets of biofeedback (Aim 3).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Facilitator Protocol
  time frame: Year 1
  description: 4-session biofeedback facilitator protocol
  measure: Feasibility/Acceptability
  time frame: Year 1
  description: Protocol implementation will be feasible in terms of recruitment (≥60% eligible enroll), intervention adherence (≥80% will receive >80% dosage), baseline/post-treatment assessment adherence (<20% missing data), and post-treatment retention (≥80%). Biofeedback will be acceptable based on session likeability ratings (80% >4:5) and qualitative themes assessed by interview indicative of likeability/benefit.
  measure: Stress Physiology
  time frame: Year 2
  measure: Stress Eating
  time frame: Year 2
  measure: Inflammatory Biomarkers
  time frame: Year 2
  measure: Insulin Sensitivity
  time frame: Year 2
  arm group label: Biofeedback
  arm group type: Experimental
  arm group label: Waitlist
  arm group type: Other
  intervention type: Behavioral
  intervention name: Biofeedback
  description: Heart-rate Variability Biofeedback
  arm group label: Biofeedback
  intervention type: Other
  intervention name: Waitlist
  description: Waitlist control group
  arm group label: Waitlist
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Elizabeth B Ruzicka, PhD
  phone: 7207770816
  email: elizabeth.ruzicka@childrenscolorado.org
  responsible party type: Principal Investigator
  investigator affiliation: Colorado State University
  investigator full name: Elizabeth Ruzicka
  investigator title: Postdoctoral Fellow
  mesh term: Overweight
  mesh term: Pediatric Obesity
  sharing ipd: No