Evaluation of Exercise Application Technology and Continuous Glucose Monitoring to Improve Weight Loss and Metabolic Markers in Adolescents
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
| 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:
|
| No Intervention: Type 2 diabetes, no intervention Type 2 diabetes, receives continuous glucose monitor |
Outcome Measures
Primary Outcome Measures
- skin fold thickness [baseline]
reliable estimate of subcutaneous fat at various sites of the body
- skin fold measurement [3 month]
reliable estimate of subcutaneous fat at various sites of the body
- skin fold measurement [6 month]
reliable estimate of subcutaneous fat at various sites of the body
- Body mass index [baseline]
measure of body fat based on height and weight
- Body mass index [3 month]
measure of body fat based on height and weight
- Body Mass Index [6 month]
measure of body fat based on height and weight
Secondary Outcome Measures
- inflammatory markers [baseline]
TNF-alpha and IL6-cytokines measured in the serum
- inflammatory markers [3 months]
TNF-alpha and IL6-cytokines measured in the serum
- inflammatory markers [6 months]
TNF-alpha and IL6-cytokines measured in the serum
Eligibility Criteria
Criteria
Inclusion Criteria
Type 2 diabetes BMI> 95th percentile A1c>6.5% Age 14-17 (2 years post menarchal)
Prediabetes Age 14-17 (2 years post menarchal)
Obese Age 14-17 (2 years post menarchal) BMI >95th percentile >95th percentile
Exclusion criteria BMI < 95th percentile
Subjects with specific syndromes associated with obesity such as Prader-Willi syndrome Diagnosis of diabetes Inability in participant in exercise application workouts
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300007608