NCT03042936

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 22, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2020

Enrollment Period

5.7 years

First QC Date

January 30, 2017

Results QC Date

November 9, 2020

Last Update Submit

February 9, 2023

Conditions

Pre Diabetes

Keywords

ChildrenTeensAdolescentsType 2 diabetesImpaired glucose toleranceExerciseNutritionEducation

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline Hemoglobin A1c

    16 weeks

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL

Insulin Superheroes Club Curriculum

Behavioral: Insulin Superheroes Club Curriculum

Interventions

Insulin Superheroes Club CurriculumBEHAVIORAL

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.

Arm 1

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 11832527BACKGROUND

  • 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.

    PMID: 28325785DERIVED

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehavior

Results Point of Contact

Title
Joan Han
Organization
UTHSC
jhan14@uthsc.edu
9012876408

Study Officials

  • Joan C Han, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 3, 2017

Study Start

March 1, 2015

Primary Completion

November 4, 2020

Study Completion

November 4, 2020

Last Updated

November 22, 2023

Results First Posted

November 22, 2023

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share