Cardiometabolic Risk Study
Reference Number: 201103056
WHAT IS THE PURPOSE OF THE STUDY?
Dr. Ginger Nicol is currently conducting a study at the Washington University School of Medicine to test the effectiveness of a 17 week family-based behavioral weight loss program in overweight or obese youth who are treated with antipsychotic medications.
WHO IS NEEDED?
Overweight or obese (BMI percentile greater than or equal to 85) children 6-18 years old who are currently being treated with antipsychotic medications for one or more childhood onset psychiatric disorders.
WHAT IS INVOLVED IF I PARTICIPATE?
Duration: Approximately 17 weeks.
Tests/Procedures: -Child and caregiver will be interviewed by phone for eligibility. Screening and initial diagnostic assessments will occur in-person or by phone.
-Eligible participants will be randomized to receive either: 1) weekly in-person diet and exercise intervention (through a family-based, behavioral weight loss program) or 2) monthly diet and exercise education.
-Medical assessments (including imaging, ECG, and blood tests) at baseline and 17 weeks.
Risks: There are no physical risks associated with the psychiatric diagnostic and assessment procedures or with the behavioral weight loss therapy provided in this study. There may be minimal risks associated with the blood draws and imaging procedures conducted in this study; these risks are the same as if your child was having a blood draw or imaging test ordered by a physician.
Benefits: Your child will be screened for risk factors for serious medical conditions that may not show any symptoms, such as heart disease, stroke, and liver disease. If your child is overweight, he/she may also acquire skills to help improve his/her diet, activity level, and ultimately, he/she may lose weight and gain the health benefits that would accompany weight reduction.
Compensation: Participants will receive reimbursement for their time and effort. Transportation can be provided as needed.
WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?
Ginger Nicol, M.D.
WHERE WILL THE STUDY TAKE PLACE?
Medical assessments will be performed at the Washington University School of Medicine in St. Louis, Barnes-Jewish Hospital, and St. Louis Children’s Hospital.
Julie Schweiger phone: 314-362-3153
Vincent Huang phone: 314-362-5939