Diabetes Prevention Program in Youth

February 9, 2023 updated by: University of Tennessee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Insulin Superheroes Club Curriculum
Behavioral: Insulin Superheroes Club Curriculum
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline Hemoglobin A1c
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Investigators

  • Principal Investigator: Joan C Han, MD, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

November 4, 2020

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimated)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-03716-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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