NCT07409064

Effects of Exercise on Lipids and Endothelial Function in Youth

Effects of Exercise on Lipids and Endothelial Function in Youth With Obesity Participating in a Weight Loss Management Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

This study is for individuals who have a BMI that is at or above the 95th percentile and are participating in the Cincinnati Children's Hospital Healthworks! Structured weight loss program. The main reason for this research study is to determine how exercise affects an individual's high level of lipids (fats) in their blood and how well their blood vessels function.

Detailed description

During participation in the study, participants will be asked to wear a watch called a Garmin Vivosmart tracker. They will wear this watch for one week at a time, three separate times during the study. The watch looks very similar to a FitBit. The study team will take measurements from the Garmin tracker at every study visit and perform a Laser flow Doppler test to assess blood flow and Veggie Meter readings to assess vegetable intake during the baseline and 6-month follow-up visits. Participants will complete all other standard-of-care Healthworks! procedures during their time in this study, including routine blood draws, mental health screenings, and physical exams. The study team will collect this information from participant medical records. It may not always be possible to align participant study visits with a clinical Healthworks visit, so participants may need to come in a separate time for the study procedures to be completed. The Twilio® text messaging platform will be used to send text message notifications and reminders during the course of study participation for follow up visits, and daily reminders for participants to record their at-home study procedures. Participants can opt-out from these notifications if they choose. The study team expects each study visit to last about an hour. The study team also expects that participants will be in this research study for 6 months.

Conditions

• Obesity & Overweight

Interventions

Type	Name	Description
OTHER	Exercise Program	Single arm study to evaluate the effectiveness of standard of care exercise program intervention. Effectiveness to be measured with a Garmin Vivosmart Fitness watch, endothelial function testing, carotenoid testing, and standard of care triglyceride level blood draw.

Timeline

• Start date: 2025-09-17
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States