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Diabetes Prevention Program in Youth

NCT ID: NCT03042936

Last Updated: 2023-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-11-04

Brief Summary

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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.

Detailed Description

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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

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Pre Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Insulin Superheroes Club Curriculum

Group Type EXPERIMENTAL

Insulin Superheroes Club Curriculum

Intervention Type 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.

Interventions

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Insulin 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan C Han, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

References

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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.

Reference Type BACKGROUND
PMID: 11832527 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28325785 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15-03716-XP

Identifier Type: -

Identifier Source: org_study_id