Effects of Exercise on Lipids and Endothelial Function in Youth With Obesity Participating in a Weight Loss Management Program
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Difference in Percent Change in Perfusion Units from Baseline to 6 months
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •1\. Physician judgement about inability to finish the protocol
Arms & Interventions
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.
Intervention: Exercise Program (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jordan Sill
Assistant Professor
Children's Hospital Medical Center, Cincinnati