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Diabetes Prevention Program in Youth

Primary Purpose

Pre Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insulin Superheroes Club Curriculum
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes focused on measuring Children, Teens, Adolescents, Type 2 diabetes, Impaired glucose tolerance, Exercise, Nutrition, Education

Eligibility Criteria

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • Between 7-15 years old
  • Parent or grandparent with pre/type II Diabetes
  • Able to participate in physical activity
  • Parent or caregiver participation

Exclusion criteria

  • Pregnant females
  • Those with significant physical or mental health illness that would hinder study participation
  • Medications that would interfere with testing results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Insulin Superheroes Club Curriculum

    Outcomes

    Primary Outcome Measures

    Change from baseline hemoglobin A1c

    Secondary Outcome Measures

    Change from baseline body mass index Z-score
    Change from baseline waist circumference Z-score
    Change from baseline systolic blood pressure Z-score
    Change from baseline diastolic blood pressure Z-score
    Change from baseline percent body fat
    Change from baseline total cholesterol
    Change from baseline LDL cholesterol
    Change from baseline HDL cholesterol
    Change from baseline non-HDL cholesterol
    Change from baseline triglycerides
    Change from baseline six minute walk test distance
    Change from baseline right handgrip strength
    Change from baseline left handgrip strength
    Change from baseline combined handgrip strength
    Change from baseline sit-and-reach lower body flexibility
    Change from baseline shuttle run speed

    Full Information

    First Posted
    January 30, 2017
    Last Updated
    May 2, 2018
    Sponsor
    University of Tennessee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03042936
    Brief Title
    Diabetes Prevention Program in Youth
    Official Title
    Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Tennessee

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre Diabetes
    Keywords
    Children, Teens, Adolescents, Type 2 diabetes, Impaired glucose tolerance, Exercise, Nutrition, Education

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Insulin Superheroes Club Curriculum
    Intervention Type
    Behavioral
    Intervention Name(s)
    Insulin Superheroes Club Curriculum
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change from baseline hemoglobin A1c
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline body mass index Z-score
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline waist circumference Z-score
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline systolic blood pressure Z-score
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline diastolic blood pressure Z-score
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline percent body fat
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline total cholesterol
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline LDL cholesterol
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline HDL cholesterol
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline non-HDL cholesterol
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline triglycerides
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline six minute walk test distance
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline right handgrip strength
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline left handgrip strength
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline combined handgrip strength
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline sit-and-reach lower body flexibility
    Time Frame
    16 weeks, 6 months, 9 months, 12 months
    Title
    Change from baseline shuttle run speed
    Time Frame
    16 weeks, 6 months, 9 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria Between 7-15 years old Parent or grandparent with pre/type II Diabetes Able to participate in physical activity Parent or caregiver participation Exclusion criteria Pregnant females Those with significant physical or mental health illness that would hinder study participation Medications that would interfere with testing results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joan C Han, MD
    Organizational Affiliation
    University of Tennessee
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11832527
    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.
    Results Reference
    background
    PubMed Identifier
    28325785
    Citation
    Mantilla C, Jones T, Decker KM, Jacobo AM, Sontheimer SY, Mirro MR, Hare ME, Han JC. Diabetes Prevention Program in Youth (Insulin Superheroes Club) Pilot: Improvement in Metabolic Parameters and Physical Fitness After 16 Weeks of Lifestyle Intervention. Diabetes Care. 2017 Jun;40(6):e63-e64. doi: 10.2337/dc16-2678. Epub 2017 Mar 21. No abstract available.
    Results Reference
    derived

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    Diabetes Prevention Program in Youth

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