Pre Diabetes
Conditions
Keywords
Children, Teens, Adolescents, Type 2 diabetes, Impaired glucose tolerance, Exercise, Nutrition, Education
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).
Interventions
BEHAVIORALInsulin 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.
Sponsors
University of Tennessee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline Hemoglobin A1c | 16 weeks |
Secondary
| Measure | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Superheroes Club Curriculum A supplement to the Centers for Disease Control and Prevention's adult Diabetes Prevention Program (DPP) designed for youth from culturally diverse, minority backgrounds.
The ISC is a 12-month, multilevel program that includes 16 weekly (phase 1), 3 biweekly (phase 2), and 6 monthly (phase 3) sessions. Participants attended sessions that included 60 min of physical fitness and 30 min of education. The education portion included interactive teaching of health-related topics (e.g., nutrition, exercise, physiology, mindfulness, and stress reduction) using hands-on learning activities (e.g., cooking, crafts, games, and role-play). All physical fitness activities incorporated moderate-intensity exercises (e.g., push-ups, yoga, basketball, tag, and dance). | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Insulin Superheroes Club Curriculum |
|---|---|
| Age, Categorical <=18 years | 33 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.8 years STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Change From Baseline Hemoglobin A1c
Time frame: 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Insulin Superheroes Club Curriculum | Change From Baseline Hemoglobin A1c | -0.5 A1c percentage points |
Secondary
Change From Baseline Body Mass Index Z-score
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Combined Handgrip Strength
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Diastolic Blood Pressure Z-score
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline HDL Cholesterol
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline LDL Cholesterol
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Left Handgrip Strength
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Non-HDL Cholesterol
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Percent Body Fat
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Right Handgrip Strength
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Shuttle Run Speed
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Sit-and-reach Lower Body Flexibility
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Six Minute Walk Test Distance
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Systolic Blood Pressure Z-score
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Total Cholesterol
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Triglycerides
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.
Secondary
Change From Baseline Waist Circumference Z-score
Time frame: 16 weeks, 6 months, 9 months, 12 months
Population: 0 participants analyzed because data could not be collected.