N/A
N=33
Diabetes Prevention Program in Youth
Pre Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03042936 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change From Baseline Hemoglobin A1c — -0.5 A1c percentage points
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insulin Superheroes Club Curriculum (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of Tennessee
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Hemoglobin A1c |
-0.5 | — |
| SECONDARY Change From Baseline Body Mass Index Z-score |
— | — |
| SECONDARY Change From Baseline Waist Circumference Z-score |
— | — |
| SECONDARY Change From Baseline Systolic Blood Pressure Z-score |
— | — |
| SECONDARY Change From Baseline Diastolic Blood Pressure Z-score |
— | — |
| SECONDARY Change From Baseline Percent Body Fat |
— | — |
| SECONDARY Change From Baseline Total Cholesterol |
— | — |
| SECONDARY Change From Baseline LDL Cholesterol |
— | — |
| SECONDARY Change From Baseline HDL Cholesterol |
— | — |
| SECONDARY Change From Baseline Non-HDL Cholesterol |
— | — |
| SECONDARY Change From Baseline Triglycerides |
— | — |
| SECONDARY Change From Baseline Six Minute Walk Test Distance |
— | — |
| SECONDARY Change From Baseline Right Handgrip Strength |
— | — |
| SECONDARY Change From Baseline Left Handgrip Strength |
— | — |
| SECONDARY Change From Baseline Combined Handgrip Strength |
— | — |
| SECONDARY Change From Baseline Sit-and-reach Lower Body Flexibility |
— | — |
| SECONDARY Change From Baseline Shuttle Run Speed |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03042936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.