Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if severely obese teens with non-alcoholic steatohepatitis (NASH) have more improvement with their NASH when they have weight loss surgery (WLS) or when they participate in a comprehensive lifestyle intervention (CLI).
We also want to test whether imaging studies and blood tests can be used to monitor the improvement in NASH after treatment (currently only a liver biopsy can do this).
Who can participate?
Severely obese teens, 12 to 19 years old, who have a diagnosis of NASH (confirmed by a liver biopsy within the last year), may be eligible for participation.
Those who have poorly controlled diabetes or cirrhosis, are taking more than 400 international units (IUs) of Vitamin E a day since the liver biopsy, or have had prior weight loss surgery, will not be able to take part in this study.
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.
What are the good things that can happen from this research?
You or your teen may or may not receive any direct benefit from participating in this study. However, potential benefits may include those resulting from the counseling about diet and exercise, or from health information obtained during the physical exams, laboratory tests and other study procedures. You or your teen’s liver disease may also improve because of treatment.
When we finish the research, we expect that we will know more about how NASH responds to CLI treatment. This may help other children and teens with NASH later on.
Will I get all the facts about the study?
You as a participant, or as a parent interested in having your teen participate, will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns, and more.
𠊊 member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until you as the participant, or a parent or guardian has signed this form and, if of age, the teen has given at minimum his/her verbal agreement.