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NCT Number: NCT07409064

Effects of Exercise on Lipids and Endothelial Function in Youth

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.

Recruiting

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Key information

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Jordan Sill, MD

CONTACT

[email protected]

513-636-4200

Jordan Sill, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 10-20 years
  • Obesity as defined by BMI ≥ 30 kg/m2 OR BMI ≥ 95%ile for age and sex
  • Planned to start the Healthworks! structured weight loss program.
  • English or Spanish speaking -

Exclusion criteria

  • Physician judgement about inability to finish the protocol

-

Treatment and study plan

exercise program

Other

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.

Primary outcomes

  1. Difference in Percent Change in Perfusion Units from Baseline to 6 months

    Time frame: 6 months

    To determine if increased levels of physical activity are associated with percent change in perfusion units utilizing laser flow doppler measurement at baseline and again after 6 months of a structured physical activity and weight loss program.

  2. Increase in Physical Activity will Lead to Change in Triglyceride Levels

    Time frame: 6 months

    To determine if higher levels of physical activity are associated with greater decreases in blood triglyceride levels in youth with obesity and hyperlipidemia undergoing a structured weight loss program.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Sill, MD

CONTACT

[email protected]

513-636-4200

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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