Diabetes Prevention Program in Youth

Not Applicable

Completed

• Conditions: Pre Diabetes
• Interventions: Behavioral: Insulin Superheroes Club Curriculum

• Registration Number: NCT03042936
• Lead Sponsor: University of Tennessee

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).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Status Verified: 2020-11
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Results First Submitted: 2020-11-09
• Results First Submitted QC: 2023-02-09
• Last Update Submitted: 2023-02-09
• Results First Posted: 2023-11-22
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Insulin Superheroes Club Curriculum	Insulin Superheroes Club Curriculum

Primary Outcome Measures

Name	Time	Method
Change From Baseline Hemoglobin A1c	16 weeks

Secondary Outcome Measures

Name	Time	Method
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 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 Percent Body Fat	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 Sit-and-reach Lower Body Flexibility	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 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