Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

There are two groups for this study: a clinical WLS group and a CLI group. You (if you are a participant who is 18 or older) or your teen will not be randomly chosen to participate in either of these groups. You or your teen will be eligible to participate in the CLI group.

These are the things that will happen while in the CLI study group:

• Measurements of blood pressure, heart rate, temperature, respiratory rate, height, weight, waist and hips
• Completion of surveys about alcohol use, liver symptoms and quality of life  
• Physical exam 
• Review of health, medical history and medication history
• Review of diet/food eaten within the last 24 hours  
• Blood draw for laboratory tests
• MRI at the beginning and end of the study
• 400-meter walk tests
• Liver biopsy for research (at end of the study to reassess liver disease status)
• Completion of Healthy Eating Plan tracker
• Meet with a Registered Dietician for individual sessions
• Completion of 6 group cooking and nutrition classes with a Registered Dietician
• Completion of 13 web-based behavioral management sessions

If you or your teen qualifies for this study, and you agree to participate, you will come to Cincinnati Children’s for 27 study visits over the next year. We will provide you or your teen with a FitBit activity monitor and ask that you or he/she wears it throughout the study.

The individual sessions with the registered dietician (RD) are each 60 minutes and will occur every other week for the first 12 weeks (or 3 months) of the study. Then, they will occur every 4 weeks, or monthly, for the remainder of the study. The RD will help you or your teen to set dietary, lifestyle and physical activity goals and incentives, as well as provide educational materials about diet, behavior and exercise.

The group cooking and nutrition classes, also 60 minutes each with the RD, occur on a monthly basis. You or your teen will learn recipes, have “hands-on” cooking activities and receive small take-away gifts to use in your home kitchen.

The web-based management sessions cover issues that are relative and important to obese teens. These topics include body image; thoughts, feelings and actions; sleep hygiene; healthy coping; and adherence.

You or your teen will have a liver biopsy after receiving treatment for 52 weeks. The biopsy will be used to determine if improvement in NASH was more common in those participants who had WLS compared to those who were treated with the CLI.  Also, we may learn more about NASH in children and teens.

Participants, parents or guardians interested in having their teen participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.