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What is the purpose of this study?
To learn the benefits and risks of a surgical approach to weight management in extremely overweight (obese) adolescents. Information will help surgeons make future treatment decisions for these adolescents.
Who will be included in this study?
Any extremely overweight adolescent (age 19 or younger) who qualifies for weight-loss surgery. The study will involve over 200 teens from all participating hospitals.
What is involved?
Initially, this study will last for two years and include six visits. However, with additional funding, we plan to continue following patients for up to five years. The following procedures will take place during the study:
- Questionnaires
- Blood work
- Measurements
What are the benefits?
Your child may receive no direct benefit. The biggest benefit is that your child may be helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Do I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form will provide detailed information on the procedures, the risks, the benefits, the compensation, whom to contact with questions or concerns, and more. A member of the study staff will review the consent form with you to ensure all questions are answered.
What are the risks?
Minimal risks regarding this study will be discussed in detail before you agree to have your child participate.
What is the pay?
Participants may receive up to $300 and parents $75 for attending all four study visits and completing the two-year study.
Whom do I contact for more information?
Cynthia Spikes
Clinical Research Coordinator
Department of Pediatric Surgery
Cincinnati Children’s Hospital Medical Center
MLC 2022
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Phone: 513-636-7932
Email: cynthia.spikes@cchmc.org
