Diabetes Prevention Program in Youth

Pre Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042936
• Other study ID #: 15-03716-XP
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

References & Publications (1)

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Hemoglobin A1c		16 weeks
Secondary	Change From Baseline Body Mass Index Z-score		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Waist Circumference Z-score		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Systolic Blood Pressure Z-score		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Diastolic Blood Pressure Z-score		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Percent Body Fat		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Total Cholesterol		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline LDL Cholesterol		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline HDL Cholesterol		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Non-HDL Cholesterol		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Triglycerides		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Six Minute Walk Test Distance		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Right Handgrip Strength		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Left Handgrip Strength		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Combined Handgrip Strength		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Sit-and-reach Lower Body Flexibility		16 weeks, 6 months, 9 months, 12 months
Secondary	Change From Baseline Shuttle Run Speed		16 weeks, 6 months, 9 months, 12 months