<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/NCT03004378</url>
  </required_header>
  <id_info>
    <org_study_id>16-0241</org_study_id>
    <nct_id>NCT03004378</nct_id>
  </id_info>
  <brief_title>Interventions for Adolescent Obesity</brief_title>
  <official_title>The Role of Activity Tracking on Weight Loss in Obese Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>Yes</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 study will evaluate whether the short-term use of activity tracking devices improves&#xD;
      short-term weight loss in adolescents. The investigators will evaluate whether weight loss&#xD;
      translates into a change in obesity-related biomarkers associated with adolescent obesity. In&#xD;
      addition, the investigators will report outcomes after the implementation of activity&#xD;
      tracking devices in conjunction with an intense adolescent weight loss program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the short-term use of activity tracking devices and their effects on&#xD;
      short- and long-term weight loss in adolescents. The investigators plan to establish whether&#xD;
      weight loss translates into a change in obesity-related biomarkers associated with adolescent&#xD;
      obesity. Each participant with an activity tracking device will have the goal of reaching&#xD;
      10,000 steps per day, in addition to their individual fitness plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.</measure>
    <time_frame>18 weeks</time_frame>
    <description>We set a study attrition rate of participants at ≤50% as the feasibility measure for the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI) (kg/m2)</measure>
    <time_frame>Change from 0 to 18 weeks</time_frame>
    <description>Absolute change in BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight (kg)</measure>
    <time_frame>Change from 0 to 18 weeks</time_frame>
    <description>Weight change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in obesity related biomarkers</measure>
    <time_frame>Change from 0 to 18 weeks</time_frame>
    <description>AST: aspartate aminotransferase; ALT: alanine aminotransferase; GGT: gamma glutamyl transferase; CRP: C reactive protein</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Adolescent Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fitbit (activity tracker) + participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Activity Tracker</intervention_name>
    <description>Fitbit Alta</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and&#xD;
        understand English Willingness to be randomized to any condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inability to obtain informed parental consent and/or child assent Inability to participate&#xD;
        in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe&#xD;
        autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety&#xD;
        Inability of the participant to speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kanika K Bowen-Jallow, MD, MMS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>adolescent</keyword>
  <keyword>tracking device</keyword>
  <keyword>fitbit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will provide all data, regardless of publication, collected as part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they are requesting. The request must include a data security plan and explanation of how the data will be stored and who will have access.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will only be available upon request</ipd_time_frame>
    <ipd_access_criteria>The request must include a data security plan and explanation of how the data will be stored and who will have access.</ipd_access_criteria>
  </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/NCT03004378
org study id: 16-0241
nct id: NCT03004378
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate whether the short-term use of activity tracking devices improves
      short-term weight loss in adolescents. The investigators will evaluate whether weight loss
      translates into a change in obesity-related biomarkers associated with adolescent obesity. In
      addition, the investigators will report outcomes after the implementation of activity
      tracking devices in conjunction with an intense adolescent weight loss program.
This study will evaluate the short-term use of activity tracking devices and their effects on
      short- and long-term weight loss in adolescents. The investigators plan to establish whether
      weight loss translates into a change in obesity-related biomarkers associated with adolescent
      obesity. Each participant with an activity tracking device will have the goal of reaching
      10,000 steps per day, in addition to their individual fitness plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.
time frame: 18 weeks
description: We set a study attrition rate of participants at ≤50% as the feasibility measure for the study.
measure: Body mass index (BMI) (kg/m2)
time frame: Change from 0 to 18 weeks
description: Absolute change in BMI
measure: Weight (kg)
time frame: Change from 0 to 18 weeks
description: Weight change
measure: Change in obesity related biomarkers
time frame: Change from 0 to 18 weeks
description: AST: aspartate aminotransferase; ALT: alanine aminotransferase; GGT: gamma glutamyl transferase; CRP: C reactive protein
arm group label: Control
arm group type: No Intervention
description: Participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.
arm group label: Intervention
arm group type: Experimental
description: Fitbit (activity tracker) + participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.
intervention type: Behavioral
intervention name: Activity Tracker
description: Fitbit Alta
arm group label: Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kanika K Bowen-Jallow, MD, MMS
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: The investigators will provide all data, regardless of publication, collected as part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they are requesting. The request must include a data security plan and explanation of how the data will be stored and who will have access.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will only be available upon request
ipd access criteria: The request must include a data security plan and explanation of how the data will be stored and who will have access.