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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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05720377
Enrollment
0
Registered
2023-02-09
Start date
2024-02-01
Completion date
2027-12-31
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, PreDiabetes, Type 2 Diabetes

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)

Interventions

DEVICEcontinuous glucose monitor (Freestyle Libre

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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

longitudinal

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
skin fold thicknessbaselinereliable estimate of subcutaneous fat at various sites of the body
skin fold measurement3 monthreliable estimate of subcutaneous fat at various sites of the body
Body mass indexbaselinemeasure of body fat based on height and weight
Body Mass Index6 monthmeasure of body fat based on height and weight

Secondary

MeasureTime frameDescription
TNF-alphabaselineinflammatory marker in the blood
IL-6Baselineinflammatory marker in the blood

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026