Effects of Exercise on Lipids and Endothelial Function in Youth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Program.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: 10 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Exercise on Lipids and Endothelial Function in Youth With Obesity Participating in a Weight Loss Management Program
Overview
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
- 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.
Primary outcome measures
- 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]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT07409064 · 2024-0557