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Completed

NCT Number: NCT03042936

Diabetes Prevention Program in Youth

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.

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Key information

Conditions

Pre Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Superheroes Club Curriculum

Behavioral

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 outcomes

  1. Change From Baseline Hemoglobin A1c

    Time frame: 16 weeks

Secondary outcomes

  1. Change From Baseline Body Mass Index Z-score

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  2. Change From Baseline Waist Circumference Z-score

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  3. Change From Baseline Systolic Blood Pressure Z-score

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  4. Change From Baseline Diastolic Blood Pressure Z-score

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  5. Change From Baseline Percent Body Fat

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  6. Change From Baseline Total Cholesterol

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  7. Change From Baseline LDL Cholesterol

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  8. Change From Baseline HDL Cholesterol

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  9. Change From Baseline Non-HDL Cholesterol

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  10. Change From Baseline Triglycerides

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  11. Change From Baseline Six Minute Walk Test Distance

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  12. Change From Baseline Right Handgrip Strength

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  13. Change From Baseline Left Handgrip Strength

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  14. Change From Baseline Combined Handgrip Strength

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  15. Change From Baseline Sit-and-reach Lower Body Flexibility

    Time frame: 16 weeks, 6 months, 9 months, 12 months

  16. Change From Baseline Shuttle Run Speed

    Time frame: 16 weeks, 6 months, 9 months, 12 months

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults)

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 3, 2017
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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