<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/NCT03042936</url>
  </required_header>
  <id_info>
    <org_study_id>15-03716-XP</org_study_id>
    <nct_id>NCT03042936</nct_id>
  </id_info>
  <brief_title>Diabetes Prevention Program in Youth</brief_title>
  <official_title>Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effectiveness of an out-of-school diabetes&#xD;
      prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Insulin Superheroes Club (ISC) is based on the Diabetes Prevention Program for adults&#xD;
      (Knowler WC et al., 2002), which was developed by the Centers for Disease Control and&#xD;
      Prevention (CDC). We have adapted the curriculum for youth to serve a supplement to the adult&#xD;
      program. This program lasts 12 months, and the goals are to improve participants' health and&#xD;
      reduce their risk of developing pre-diabetes or type 2 diabetes. The ISC program includes 16&#xD;
      weekly (Phase 1), 3 bi-weekly (Phase 2), and 6 monthly (Phase 3) sessions. Sessions include&#xD;
      60 minutes of physical fitness and 30 minutes of education. The education portion includes&#xD;
      interactive teaching of a health-related topic (e.g., nutrition, exercise, physiology,&#xD;
      mindfulness, and stress reduction) using a hand-on learning activity (e.g., cooking, crafts,&#xD;
      games, and role play). All physical fitness activities incorporate moderate intensity&#xD;
      exercises (e.g., push-ups, yoga, basketball, tag, and dance).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline hemoglobin A1c</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline body mass index Z-score</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline waist circumference Z-score</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline systolic blood pressure Z-score</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline diastolic blood pressure Z-score</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline percent body fat</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline total cholesterol</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline LDL cholesterol</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline HDL cholesterol</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline non-HDL cholesterol</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline triglycerides</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline six minute walk test distance</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline right handgrip strength</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline left handgrip strength</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline combined handgrip strength</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline sit-and-reach lower body flexibility</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline shuttle run speed</measure>
    <time_frame>16 weeks, 6 months, 9 months, 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Pre Diabetes</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin Superheroes Club Curriculum</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Insulin Superheroes Club Curriculum</intervention_name>
    <description>This curriculum promotes healthier physical activity, nutrition, sleep, and stress coping practices. The intervention lasts 12-months: registration, six evaluation sessions (2-3 hours per evaluation: Weeks 1, 8, and 16, 6-month, 9-month, and 12-month), and 16-weekly, 3-bi weekly, 6-monthly educational and physical activity sessions each lasting 90 minutes.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Between 7-15 years old&#xD;
&#xD;
          -  Parent or grandparent with pre/type II Diabetes&#xD;
&#xD;
          -  Able to participate in physical activity&#xD;
&#xD;
          -  Parent or caregiver participation&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Those with significant physical or mental health illness that would hinder study&#xD;
             participation&#xD;
&#xD;
          -  Medications that would interfere with testing results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan C Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <reference>
    <citation>Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.</citation>
    <PMID>11832527</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Tennessee</investigator_affiliation>
    <investigator_full_name>Joan C. Han, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Teens</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Impaired glucose tolerance</keyword>
  <keyword>Exercise</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 9, 2020</submitted>
    <returned>December 2, 2020</returned>
    <submitted>February 9, 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/NCT03042936
org study id: 15-03716-XP
nct id: NCT03042936
lead sponsor: 
has dmc: No
The purpose of this study is to test the effectiveness of an out-of-school diabetes
      prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2
      diabetes.
The Insulin Superheroes Club (ISC) is based on the Diabetes Prevention Program for adults
      (Knowler WC et al., 2002), which was developed by the Centers for Disease Control and
      Prevention (CDC). We have adapted the curriculum for youth to serve a supplement to the adult
      program. This program lasts 12 months, and the goals are to improve participants' health and
      reduce their risk of developing pre-diabetes or type 2 diabetes. The ISC program includes 16
      weekly (Phase 1), 3 bi-weekly (Phase 2), and 6 monthly (Phase 3) sessions. Sessions include
      60 minutes of physical fitness and 30 minutes of education. The education portion includes
      interactive teaching of a health-related topic (e.g., nutrition, exercise, physiology,
      mindfulness, and stress reduction) using a hand-on learning activity (e.g., cooking, crafts,
      games, and role play). All physical fitness activities incorporate moderate intensity
      exercises (e.g., push-ups, yoga, basketball, tag, and dance).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline hemoglobin A1c
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline body mass index Z-score
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline waist circumference Z-score
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline systolic blood pressure Z-score
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline diastolic blood pressure Z-score
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline percent body fat
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline total cholesterol
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline LDL cholesterol
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline HDL cholesterol
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline non-HDL cholesterol
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline triglycerides
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline six minute walk test distance
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline right handgrip strength
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline left handgrip strength
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline combined handgrip strength
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline sit-and-reach lower body flexibility
time frame: 16 weeks, 6 months, 9 months, 12 months
measure: Change from baseline shuttle run speed
time frame: 16 weeks, 6 months, 9 months, 12 months
arm group label: Arm 1
arm group type: Experimental
description: Insulin Superheroes Club Curriculum
intervention type: Behavioral
intervention name: Insulin Superheroes Club Curriculum
description: This curriculum promotes healthier physical activity, nutrition, sleep, and stress coping practices. The intervention lasts 12-months: registration, six evaluation sessions (2-3 hours per evaluation: Weeks 1, 8, and 16, 6-month, 9-month, and 12-month), and 16-weekly, 3-bi weekly, 6-monthly educational and physical activity sessions each lasting 90 minutes.
arm group label: Arm 1
criteria: 
gender: All
minimum age: 7 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joan C Han, MD
role: Principal Investigator
affiliation: University of Tennessee
citation: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PMID: 11832527
responsible party type: Principal Investigator
investigator affiliation: University of Tennessee
investigator full name: Joan C. Han, MD
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Prediabetic State
mesh term: Insulin
sharing ipd: No
submitted: November 9, 2020
returned: December 2, 2020
submitted: February 9, 2023