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Pre DiabetesNCT03042936

Diabetes Prevention Program in Youth

A study testing Insulin Superheroes Club Curriculum in people with Pre Diabetes, run by University of Tennessee.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Pre Diabetes
What is being tested?
Insulin Superheroes Club Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Mar 2015to 4 Nov 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Between 7-15 years old
  • Parent or grandparent with pre/type II Diabetes
  • Able to participate in physical activity
  • Parent or caregiver participation

Who cannot join

  • Pregnant females
  • Those with significant physical or mental health illness that would hinder study participation
  • Medications that would interfere with testing results

About this study

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

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.

Read the 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).

Conditions
Pre Diabetes
Being tested
Insulin Superheroes Club Curriculum
Keywords
Children, Teens, Adolescents, Type 2 diabetes, Impaired glucose tolerance, Exercise, Nutrition, Education
Medical subject headings
Glucose Intolerance, Diabetes Mellitus, Type 2, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Superheroes Club CurriculumBehavioural

    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.

Study groups in NCT03042936
Study groupRoleWhat they receive
Arm 1ExperimentalInsulin Superheroes Club Curriculum
Receives: Behavioral: Insulin Superheroes Club Curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline Hemoglobin A1c

    Measured: 16 weeks

Secondary outcomes (16)

  1. Change From Baseline Body Mass Index Z-score

    Measured: 16 weeks, 6 months, 9 months, 12 months

  2. Change From Baseline Waist Circumference Z-score

    Measured: 16 weeks, 6 months, 9 months, 12 months

  3. Change From Baseline Systolic Blood Pressure Z-score

    Measured: 16 weeks, 6 months, 9 months, 12 months

  4. Change From Baseline Diastolic Blood Pressure Z-score

    Measured: 16 weeks, 6 months, 9 months, 12 months

  5. Change From Baseline Percent Body Fat

    Measured: 16 weeks, 6 months, 9 months, 12 months

  6. Change From Baseline Total Cholesterol

    Measured: 16 weeks, 6 months, 9 months, 12 months

  7. Change From Baseline LDL Cholesterol

    Measured: 16 weeks, 6 months, 9 months, 12 months

  8. Change From Baseline HDL Cholesterol

    Measured: 16 weeks, 6 months, 9 months, 12 months

  9. Change From Baseline Non-HDL Cholesterol

    Measured: 16 weeks, 6 months, 9 months, 12 months

  10. Change From Baseline Triglycerides

    Measured: 16 weeks, 6 months, 9 months, 12 months

  11. Change From Baseline Six Minute Walk Test Distance

    Measured: 16 weeks, 6 months, 9 months, 12 months

  12. Change From Baseline Right Handgrip Strength

    Measured: 16 weeks, 6 months, 9 months, 12 months

  13. Change From Baseline Left Handgrip Strength

    Measured: 16 weeks, 6 months, 9 months, 12 months

  14. Change From Baseline Combined Handgrip Strength

    Measured: 16 weeks, 6 months, 9 months, 12 months

  15. Change From Baseline Sit-and-reach Lower Body Flexibility

    Measured: 16 weeks, 6 months, 9 months, 12 months

  16. Change From Baseline Shuttle Run Speed

    Measured: 16 weeks, 6 months, 9 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study startMar 2015
  3. Primary completion4 Nov 2020
  4. Study completion4 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03042936
Sponsor's protocol ID
15-03716-XP
Status last verified
Nov 2020
First submitted
30 Jan 2017
Last updated
22 Nov 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11832527

  • 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.

    PubMed 28325785

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Superheroes Club Curriculum in people with Pre Diabetes, run by University of Tennessee.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Hemoglobin A1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03042936, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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