Obesity & Overweight
Conditions
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.
Interventions
OTHERExercise 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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percent Change in Perfusion Units from Baseline to 6 months | 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 | 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. |
Countries
United States
Contacts
CONTACTJordan Sill, MD
Outcome results
None listed