Diabetes Prevention Program in Youth

Study 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).

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

Conditions
-----------------
Pre Diabetes

Intervention / Treatment
-----------------
* Behavioral: Insulin Superheroes Club Curriculum


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Insulin Superheroes Club Curriculum | Behavioral: Insulin Superheroes Club Curriculum<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Hemoglobin A1c |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 HDL Cholesterol |  | 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 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 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 Sit-and-reach Lower Body Flexibility |  | 16 weeks, 6 months, 9 months, 12 months | 
| Change From Baseline Shuttle Run Speed |  | 16 weeks, 6 months, 9 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Teens, Adolescents, Type 2 diabetes, Impaired glucose tolerance, Exercise, Nutrition, Education