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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Other: Exercise Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Sill, MD; Phone Number: 513-636-4200; Email: jordan.sill@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Jordan Sill, MD; Phone Number: 513-636-4200; Email: jordan.sill@cchmc.org
      • Principal Investigator: Jordan Sill, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Physician judgement about inability to finish the protocol

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthworks! Structured Weight Loss Participants; Participants who are already participating in the Healthworks! structured weight loss program who are between the ages of 10-20 years old.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Percent Change in Perfusion Units from Baseline to 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.	6 months
Increase in Physical Activity will Lead to Change in Triglyceride Levels	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.	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: 2024-0557

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No