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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Insulin Superheroes Club Curriculum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Superheroes Club Curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Hemoglobin A1c | 16 weeks |
| Measure | Description | 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 | |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joan C Han, MD | University of Tennessee | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11832527 | Background | 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. | |
| 28325785 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Hemoglobin A1c | Posted | Median | Inter-Quartile Range | A1c percentage points | 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Han | UTHSC | 9012876408 | jhan14@uthsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2017 | Dec 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline Body Mass Index Z-score | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Waist Circumference Z-score | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Systolic Blood Pressure Z-score | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Diastolic Blood Pressure Z-score | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Percent Body Fat | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Total Cholesterol | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline LDL Cholesterol | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline HDL Cholesterol | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Non-HDL Cholesterol | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Triglycerides | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Six Minute Walk Test Distance | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Right Handgrip Strength | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Left Handgrip Strength | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Combined Handgrip Strength | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Sit-and-reach Lower Body Flexibility | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| Secondary | Change From Baseline Shuttle Run Speed | 0 participants analyzed because data could not be collected. | Posted | 16 weeks, 6 months, 9 months, 12 months |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |