Evaluation of Exercise Application Technology in Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will be recruited directly from the Childrens of Alabama pediatric endocrine clinic. Thirty patients who have obesity, prediabetes or Type 2 diabetes will be enrolled. During the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. Our study team will approach interested participants during their routine clinic visit. Consent will be obtained by study team during their endocrine clinic visit. Review of their medical records will be done and age, gender and race will be extracted from the medical record. A baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. Once enrolled, the patients will then be randomized.Within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or Type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. The randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and Type 2 diabetes. Those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. Follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw. Intervention Group Access provided to exercise application Provided with Fitbit to wear and measure activity Weekly check-in with provider to determine how exercise goals have been that week. If unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week. Meeting with nutrition at Baseline visit Continuous glucose monitor provided (plan to wear for 14 days during each month) Non-Intervention Group Meeting with nutrition at Baseline visit Continuous glucose monitor provided (plan to wear for 14 days at baseline visit, 3 month visit and 6 month visit)

Official Title
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Evaluation of Exercise Application Technology and Continuous Glucose Monitoring to Improve Weight Loss and Metabolic Markers in Adolescents

Conditions
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Type 2 Diabetes, PreDiabetes, Obesity

Intervention / Treatment
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* Device: continuous glucose monitor (Freestyle Libre


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: longitudinal
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese, receives access to exercise phone application<br>obese, receives access to exercise phone application and interval contact by health provider in between clinic visits , receives continuous glucose monitor | Device: continuous glucose monitor (Freestyle Libre<br>* 15 minute phone interview by health care provider to assess health goals set at clinic visits.<br>* Other names: Contact by health care provider;|
| No Intervention: Obese, no intervention<br>obese, receives continuous glucose monitor | |
| Experimental: Prediabetes, receives access to exercise phone application<br>prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor | Device: continuous glucose monitor (Freestyle Libre<br>* 15 minute phone interview by health care provider to assess health goals set at clinic visits.<br>* Other names: Contact by health care provider;|
| No Intervention: Prediabetes, no intervention<br>prediabetes, receives continuous glucose monitor | |
| Experimental: Type 2 diabetes, receives access to exercise phone application<br>prediabetes receives access to exercise phone application and interval contact by health provider in between clinic visit, receives continuous glucose monitor | Device: continuous glucose monitor (Freestyle Libre<br>* 15 minute phone interview by health care provider to assess health goals set at clinic visits.<br>* Other names: Contact by health care provider;|
| No Intervention: Type 2 diabetes, no intervention<br>Type 2 diabetes, receives continuous glucose monitor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin fold thickness | reliable estimate of subcutaneous fat at various sites of the body | baseline | 
| skin fold measurement | reliable estimate of subcutaneous fat at various sites of the body | 3 month | 
| skin fold measurement | reliable estimate of subcutaneous fat at various sites of the body | 6 month | 
| Body mass index | measure of body fat based on height and weight | baseline | 
| Body mass index | measure of body fat based on height and weight | 3 month | 
| Body Mass Index | measure of body fat based on height and weight | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha | inflammatory marker in the blood | baseline | 
| TNF-alpha | inflammatory marker in the blood | 3 months | 
| TNF-alpha | inflammatory marker in the blood | 6 months | 
| IL-6 | inflammatory marker in the blood | Baseline | 
| IL-6 | inflammatory marker in the blood | 3 months | 
| IL-6 | inflammatory marker in the blood | 6 months |