<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/NCT03284788</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701609-N</org_study_id>
    <secondary_id>K01HL141535</secondary_id>
    <secondary_id>PA-16-190</secondary_id>
    <nct_id>NCT03284788</nct_id>
  </id_info>
  <brief_title>Wellness Achieved Through Changing Habits (The WATCH Study)</brief_title>
  <official_title>Wellness Achieved Through Changing Habits (The WATCH Study)</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 pilot, feasibility study is to investigate the acceptability of an&#xD;
      acceptance-based therapy healthy lifestyle intervention in adolescent girls with&#xD;
      overweight/obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT&#xD;
      healthy lifestyle intervention.&#xD;
&#xD;
      The intervention will include 15 sessions over 6 months.&#xD;
&#xD;
      A post-treatment visit will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2018</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in participant recruitment rate</measure>
    <time_frame>Baseline; Week 8</time_frame>
    <description>The recruitment strategy will be deemed &quot;feasible&quot; if approximately 15 participants are recruited within 8 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in participant attrition rate</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>The attrition strategy will be deemed &quot;feasible&quot; if there is less than 50% attrition at the end of the 6-month intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of enrollees</measure>
    <time_frame>Baseline; Week 1</time_frame>
    <description>The study will be deemed &quot;acceptable&quot; if at least 80% of enrolled participants decide to participate in the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of sessions completed by those who completed the intervention</measure>
    <time_frame>Week 1; Week 24</time_frame>
    <description>The study will be deemed &quot;acceptable&quot; if at least 70% of intervention completers attend all sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in BMI Z-score</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>Measurement of relative weight at pre- and post-treatment adjusted for participant age and sex</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</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 girls will attend healthy lifestyle 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>
  <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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent girls between ages 14-19 with overweight or obesity 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;
          -  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 begun a course of or changed the dosage of any medications known to affect&#xD;
             appetite or body composition within the previous 3 months&#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>HealthStreet and University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</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>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</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>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 9, 2023</submitted>
    <returned>June 27, 2023</returned>
    <submitted>July 21, 2023</submitted>
    <returned>August 18, 2023</returned>
    <submitted>September 12, 2023</submitted>
  </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/NCT03284788
org study id: IRB201701609-N
secondary id: K01HL141535
secondary id: PA-16-190
nct id: NCT03284788
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot, feasibility study is to investigate the acceptability of an
      acceptance-based therapy healthy lifestyle intervention in adolescent girls with
      overweight/obesity.
Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT
      healthy lifestyle intervention.

      The intervention will include 15 sessions over 6 months.

      A post-treatment visit will occur.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in participant recruitment rate
time frame: Baseline; Week 8
description: The recruitment strategy will be deemed "feasible" if approximately 15 participants are recruited within 8 weeks.
measure: Change in participant attrition rate
time frame: Baseline; Month 6
description: The attrition strategy will be deemed "feasible" if there is less than 50% attrition at the end of the 6-month intervention.
measure: Change in number of enrollees
time frame: Baseline; Week 1
description: The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.
measure: Change in number of sessions completed by those who completed the intervention
time frame: Week 1; Week 24
description: The study will be deemed "acceptable" if at least 70% of intervention completers attend all sessions.
measure: Change in BMI Z-score
time frame: Baseline; Month 6
description: Measurement of relative weight at pre- and post-treatment adjusted for participant age and sex
arm group label: ABT Weight Loss Intervention
arm group type: Experimental
description: Adolescent girls will attend healthy lifestyle 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.
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
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: Overweight
mesh term: Weight Loss
sharing ipd: No
submitted: June 9, 2023
returned: June 27, 2023
submitted: July 21, 2023
returned: August 18, 2023
submitted: September 12, 2023