Clinical trial NCT03042936: Diabetes Prevention Program in Youth
Official title: Insulin Superheroes Club: Diabetes Prevention Program in Youth (12-month Supplement to the CDC DPP for Adults)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Keywords: Children
Teens
Adolescents
Type 2 diabetes
Impaired glucose tolerance
Exercise
Nutrition
Education
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change From Baseline Hemoglobin A1c
timeFrame: 16 weeks
Secondary outcomes:
measure: Change From Baseline Body Mass Index Z-score
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Waist Circumference Z-score
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Systolic Blood Pressure Z-score
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Diastolic Blood Pressure Z-score
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Percent Body Fat
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Total Cholesterol
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline LDL Cholesterol
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline HDL Cholesterol
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Non-HDL Cholesterol
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Triglycerides
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Six Minute Walk Test Distance
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Right Handgrip Strength
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Left Handgrip Strength
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Combined Handgrip Strength
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Sit-and-reach Lower Body Flexibility
timeFrame: 16 weeks, 6 months, 9 months, 12 months
measure: Change From Baseline Shuttle Run Speed
timeFrame: 16 weeks, 6 months, 9 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Tennessee
name: Joan C Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mantilla C, Jones T, Decker KM, Jacobo AM, Sontheimer SY, Mirro MR, Hare ME, Han JC. Diabetes Prevention Program in Youth (Insulin Superheroes Club) Pilot: Improvement in Metabolic Parameters and Physical Fitness After 16 Weeks of Lifestyle Intervention. Diabetes Care. 2017 Jun;40(6):e63-e64. doi: 10.2337/dc16-2678. Epub 2017 Mar 21. No abstract available.