Recruiting

Healthworks! Program

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07409064

Conditions

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 10 - 20

Healthy Volunteers: Not accepted

Interventions

Exercise Program

Study Details

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

Study ID

NCT07409064

Start date

Sep 17, 2025

Status verified date

Jan, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 20

Healthy Volunteers: Not accepted

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

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Study Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Difference in Percent Change in Perfusion Units from Baseline to 6 months [ Time Frame: 6 months ]
  • Increase in Physical Activity will Lead to Change in Triglyceride Levels [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jordan Sill, MD

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

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jordan Sill, MD

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

Principal Investigator:

Jordan Sill, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Feb 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-02-13.