Skip to main content
Clinical Trials/NCT03042936
NCT03042936
Completed
Not Applicable

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

University of Tennessee0 sites33 target enrollmentMarch 2015
ConditionsPre Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre Diabetes
Sponsor
University of Tennessee
Enrollment
33
Primary Endpoint
Change From Baseline Hemoglobin A1c
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
November 4, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change From Baseline Hemoglobin A1c

Time Frame: 16 weeks

Secondary Outcomes

  • Change From Baseline HDL Cholesterol(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Triglycerides(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Six Minute Walk Test Distance(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Non-HDL Cholesterol(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Right Handgrip Strength(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Left Handgrip Strength(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Combined Handgrip Strength(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Body Mass Index Z-score(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Waist Circumference Z-score(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Systolic Blood Pressure Z-score(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Diastolic Blood Pressure Z-score(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Sit-and-reach Lower Body Flexibility(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Percent Body Fat(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Total Cholesterol(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline LDL Cholesterol(16 weeks, 6 months, 9 months, 12 months)
  • Change From Baseline Shuttle Run Speed(16 weeks, 6 months, 9 months, 12 months)

Similar Trials