Evaluation of Exercise Application Technology in Adolescents

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05720377
• Other study ID #: IRB-300007608
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Device:
• continuous glucose monitor (Freestyle Libre
15 minute phone interview by health care provider to assess health goals set at clinic visits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin fold thickness	reliable estimate of subcutaneous fat at various sites of the body	baseline
Primary	skin fold measurement	reliable estimate of subcutaneous fat at various sites of the body	3 month
Primary	skin fold measurement	reliable estimate of subcutaneous fat at various sites of the body	6 month
Primary	Body mass index	measure of body fat based on height and weight	baseline
Primary	Body mass index	measure of body fat based on height and weight	3 month
Primary	Body Mass Index	measure of body fat based on height and weight	6 month
Secondary	TNF-alpha	inflammatory marker in the blood	baseline
Secondary	TNF-alpha	inflammatory marker in the blood	3 months
Secondary	TNF-alpha	inflammatory marker in the blood	6 months
Secondary	IL-6	inflammatory marker in the blood	Baseline
Secondary	IL-6	inflammatory marker in the blood	3 months
Secondary	IL-6	inflammatory marker in the blood	6 months