Nutrition and Blood Pressure Study For Children and Teens 11 to 18 Years Old
What is the purpose of this study?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial, to compare the effects of different nutrition plans on blood pressure and blood vessel function.
Who will be included in this study?
- Children and teenagers 11 to 18 years old with high or borderline high blood pressure AND who are not taking medicine to control their blood pressure or medicine to treat ADHD may be eligible to participate.
- Participants should be seen in the Cincinnati Children’s Hypertension Center (CCHC) prior to being enrolled in this study.
What is involved?
The study lasts for up to 18 months and includes 4 visits. You (if 18) or your child will be “randomized” into one of the study groups. Being “randomized” means that you or your child will be put into a group completely by chance (like flipping a coin). If you give permission to participate and you or your child qualifies for the study, a member of the study staff will review the study tests and procedures with you.
What are the benefits?
You or your child may receive no direct benefit from participating in this study. Potential benefits for your child may include a reduction in your child’s blood pressure and an improvement in how your child’s blood vessels respond to changes in blood flow. The greatest benefit is that the information learned from this research study may benefit other patients with high blood pressure in the future.
Will I get all the facts about the study?
If you are interested in participating or having your child participate, you 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. A 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 have signed this form and, if of age, your child has given at minimum his/her verbal agreement.
What are the risks and discomforts of the study?
There are no known medical risks involved with this study.
What is the pay?
Participants will receive a free echocardiogram (heart ultrasound) at the first visit and will receive between $50 and $100 for each additional visit. Additional compensation may be provided for meeting study-related goals.
Who should I contact for more information?
To receive further information and/or make an appointment, call the Cincinnati Children’s Hypertension Center (CCHC) at 513-636-4287.
Investigator Information:
Elaine Urbina, MD
Cincinnati Children’s Principal Investigator
Division of Cardiology
Cincinnati Children’s Hospital Medical Center
Sarah Couch, PhD
University of Cincinnati Principal Investigator
Department of Nutritional Sciences
University of Cincinnati
