<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/NCT04484831</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701609</org_study_id>
    <secondary_id>K01HL141535</secondary_id>
    <secondary_id>PA-16-190</secondary_id>
    <nct_id>NCT04484831</nct_id>
  </id_info>
  <brief_title>A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity</brief_title>
  <official_title>An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>StayWell</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>WellCare Health Plans, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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 purpose of this study is to investigate the effects of an acceptance-based therapy weight&#xD;
      loss intervention compared with enhanced care for adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will complete baseline assessments and adolescents will be randomized to either&#xD;
      an ABT weight loss intervention or enhanced care.&#xD;
&#xD;
      The intervention will include 15 sessions over 6 months. Enhanced care will include 15&#xD;
      healthy lifestyle handouts over 6 months.&#xD;
&#xD;
      Post-treatment assessments will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI Change</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>Measurements of quality of life (using the valid Pediatric Quality of Life Inventory assessment: scores 0-100) will be conducted. Higher scores indicate better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression using the valid Beck Depression Inventory-II</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>Measurements of depression level (using the valid Beck Depression Inventory-II assessment) will be conducted. Higher scores indicate higher levels of depression and a score of 30 or greater is indicative of severe clinical depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety-sensitivity using the valid Short Scale Anxiety Sensitivity Index assessment</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>Measurements of anxiety-sensitivity (using the valid Short Scale Anxiety Sensitivity Index-3 assessment: scores 0-20) will be conducted. Higher scores indicate higher anxiety-sensitivity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Weight Loss</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>ABT Weight Loss Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ABT Weight Loss Intervention</intervention_name>
    <description>This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.</description>
    <arm_group_label>ABT Weight Loss Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Care</intervention_name>
    <description>This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.</description>
    <arm_group_label>Enhanced Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent between ages 14-19 with overweight or obesity at or above the 85th&#xD;
             percentile for sex and age as determined by CDC growth charts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy or plans to become pregnant in the next 2 years&#xD;
&#xD;
          -  Plans to move out of the area in the next year&#xD;
&#xD;
          -  Autism, any intellectual disability (e.g., down syndrome)&#xD;
&#xD;
          -  Any condition prohibiting physical activity&#xD;
&#xD;
          -  A diagnosis of cardiovascular disease or diabetes&#xD;
&#xD;
          -  Have active cancer or cancer requiring treatment in the past 2 years&#xD;
&#xD;
          -  Have active or chronic infections (e.g., HIV or TB)&#xD;
&#xD;
          -  Have active kidney disease or lung disease&#xD;
&#xD;
          -  An eating disorder or substance abuse disorder&#xD;
&#xD;
          -  Having recently begun a course of or changed the dosage of any medications known to&#xD;
             affect appetite or body composition&#xD;
&#xD;
          -  Weight loss greater than or equal to 5% in the previous 6 months&#xD;
&#xD;
          -  If they do not follow the study plan&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle I Cardel, PhD, MS, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acceptance-based therapy</keyword>
  <keyword>adolescents</keyword>
  <keyword>weight</keyword>
  <keyword>weight loss</keyword>
  <keyword>obesity</keyword>
  <keyword>overweight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 7, 2023</submitted>
    <returned>July 27, 2023</returned>
    <submitted>August 10, 2023</submitted>
    <returned>August 28, 2023</returned>
  </pending_results>
  <!-- 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/NCT04484831
org study id: IRB201701609
secondary id: K01HL141535
secondary id: PA-16-190
nct id: NCT04484831
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effects of an acceptance-based therapy weight
      loss intervention compared with enhanced care for adolescents.
Participants will complete baseline assessments and adolescents will be randomized to either
      an ABT weight loss intervention or enhanced care.

      The intervention will include 15 sessions over 6 months. Enhanced care will include 15
      healthy lifestyle handouts over 6 months.

      Post-treatment assessments will occur.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: BMI Change
time frame: Baseline; Month 6
description: Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
measure: Change in quality of life
time frame: Baseline; Month 6
description: Measurements of quality of life (using the valid Pediatric Quality of Life Inventory assessment: scores 0-100) will be conducted. Higher scores indicate better health-related quality of life.
measure: Change in depression using the valid Beck Depression Inventory-II
time frame: Baseline; Month 6
description: Measurements of depression level (using the valid Beck Depression Inventory-II assessment) will be conducted. Higher scores indicate higher levels of depression and a score of 30 or greater is indicative of severe clinical depression.
measure: Change in anxiety-sensitivity using the valid Short Scale Anxiety Sensitivity Index assessment
time frame: Baseline; Month 6
description: Measurements of anxiety-sensitivity (using the valid Short Scale Anxiety Sensitivity Index-3 assessment: scores 0-20) will be conducted. Higher scores indicate higher anxiety-sensitivity.
arm group label: ABT Weight Loss Intervention
arm group type: Experimental
description: Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
arm group label: Enhanced Care
arm group type: Placebo Comparator
description: Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
intervention type: Behavioral
intervention name: ABT Weight Loss Intervention
description: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
arm group label: ABT Weight Loss Intervention
intervention type: Other
intervention name: Enhanced Care
description: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
arm group label: Enhanced Care
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: No
last name: Michelle I Cardel, PhD, MS, RD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Weight Loss
sharing ipd: No
submitted: July 7, 2023
returned: July 27, 2023
submitted: August 10, 2023
returned: August 28, 2023