Evaluation of Exercise Application Technology in Adolescents

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Device: continuous glucose monitor (Freestyle Libre

Detailed Description

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)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christy Foster; Phone Number: 205-638-9107; Email: cafoster@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
      • Contact: Christy Foster, MD; Email: cafoster@uabmc.edu
      • Principal Investigator: Christy Foster, MD
      • Sub-Investigator: Jessica Schmitt, MD
      • Sub-Investigator: Grant Adams, CRNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese, receives access to exercise phone application; 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; 15 minute phone interview by health care provider to assess health goals set at clinic visits.; Other Names: Contact by health care provider
No Intervention: Obese, no intervention; obese, receives continuous glucose monitor
Experimental: Prediabetes, receives access to exercise phone application; 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; 15 minute phone interview by health care provider to assess health goals set at clinic visits.; Other Names: Contact by health care provider
No Intervention: Prediabetes, no intervention; prediabetes, receives continuous glucose monitor
Experimental: Type 2 diabetes, receives access to exercise phone application; 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; 15 minute phone interview by health care provider to assess health goals set at clinic visits.; Other Names: Contact by health care provider
No Intervention: Type 2 diabetes, no intervention; Type 2 diabetes, receives continuous glucose monitor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2024
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB-300007608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No