WithdrawnNot Applicable

Evaluation of Exercise Application Technology in Adolescents

Stopped: Funding not obtained

0Started 2024-02-01

Plain-language summary

The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.

Who can participate

Age range

14 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Type 2 diabetes arm * BMI \> 95th percentile * A1c\> 6.5% * Age 14-17 (2 years post-menarchal) Inclusion for Prediabetes Arm * Age 14-17 (2 years post-menarchal) * A1c 5.7-6.4% Inclusion for Obesity Arm * Age 14-17 (2 years post-menarchal) * A1c 5.7-6.4% Exclusion Criteria for all arms * BMI \<95th percentile * Specific obesity syndrome * Inability to participate in exercise workouts

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was listed as 'withdrawn' before it even enrolled anyone — are there any similar ongoing studies looking at exercise apps for adolescents with type 2 diabetes, prediabetes, or obesity that my child might be eligible for instead?
2The trial was focused on measuring changes in BMI and skin fold thickness in teenagers — given my child's current situation with weight and blood sugar, is tracking these specific physical measurements something we should be doing regularly as part of their care plan regardless of a trial?
3Since this study involved an exercise app technology for adolescents, are there any evidence-based digital tools or structured physical activity programs you'd recommend we try now, rather than waiting for a clinical trial to become available?
4Because this trial was withdrawn before starting, we don't have any safety or outcome data from it — what does current evidence say about using app-based exercise programs to manage prediabetes or obesity in teenagers?
5Would it make sense to focus on standard lifestyle interventions like nutrition counseling or supervised exercise programs first, while keeping an eye out for future trials that pick up where this one left off?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

skin fold thickness

Timeframe: baseline

skin fold measurement

Timeframe: 3 month

skin fold measurement

Timeframe: 6 month

Body mass index

Timeframe: baseline

Body mass index

Timeframe: 3 month

Body Mass Index

Timeframe: 6 month

Trial details

NCT IDNCT05720377

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Type 2 Diabetes trials