Effects of Exercise on Lipids and Endothelial Function in Youth

NCT07409064 | Recruiting

• 1 other identifier: 2024-0557
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthworks! Structured Weight Loss Participants

OTHER

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

Interventions

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.

Healthworks! Structured Weight Loss Participants

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• \. Physician judgement about inability to finish the protocol

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jordan Sill, MD

CONTACT

513-636-4200; jordan.sill@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 13, 2026
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

US (1)