Evaluation of Exercise Application Technology in Adolescents

NCT ID: NCT05720377

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2027-12-31

Brief 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.

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)

Conditions

Type 2 Diabetes; PreDiabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

continuous glucose monitor (Freestyle Libre

Intervention Type: DEVICE

15 minute phone interview by health care provider to assess health goals set at clinic visits.

Obese, no intervention

obese, receives continuous glucose monitor

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

continuous glucose monitor (Freestyle Libre

Intervention Type: DEVICE

15 minute phone interview by health care provider to assess health goals set at clinic visits.

Prediabetes, no intervention

prediabetes, receives continuous glucose monitor

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

continuous glucose monitor (Freestyle Libre

Intervention Type: DEVICE

15 minute phone interview by health care provider to assess health goals set at clinic visits.

Type 2 diabetes, no intervention

Type 2 diabetes, receives continuous glucose monitor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

continuous glucose monitor (Freestyle Libre

15 minute phone interview by health care provider to assess health goals set at clinic visits.

Intervention Type: DEVICE

Other Intervention Names

Contact by health care provider

Eligibility Criteria

Inclusion Criteria

• 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

• BMI <95th percentile
• Specific obesity syndrome
• Inability to participate in exercise workouts

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Christy Foster

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB-300007608

Identifier Type: -

Identifier Source: org_study_id