Diabetes Prevention Program in Youth

February 9, 2023 updated by: University of Tennessee

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Insulin Superheroes Club Curriculum
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline Hemoglobin A1c
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline Body Mass Index Z-score
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Waist Circumference Z-score
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Systolic Blood Pressure Z-score
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Diastolic Blood Pressure Z-score
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Percent Body Fat
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Total Cholesterol
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline LDL Cholesterol
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline HDL Cholesterol
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Non-HDL Cholesterol
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Triglycerides
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Six Minute Walk Test Distance
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Right Handgrip Strength
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Left Handgrip Strength
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Combined Handgrip Strength
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Sit-and-reach Lower Body Flexibility
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months
Change From Baseline Shuttle Run Speed
Time Frame: 16 weeks, 6 months, 9 months, 12 months
16 weeks, 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tennessee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joan C Han, MD, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-03716-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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