CINCINNATI—Researchers at the University of Cincinnati (UC) have been approved for a $12.9 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) to assess strategies for minimizing obesity and weight gain in children with bipolar disorders.
Melissa DelBello, MD, will be the principal investigator at UC for the study, which will also involve many researchers at Cincinnati Children’s Hospital Medical Center and Long Island Jewish Medical Center in New York. DelBello is the Dr. Stanley and Mickey Kaplan Professor and Chair of the Department of Psychiatry and Behavioral Neuroscience at the UC College of Medicine, a UC Health psychiatrist and co-director of the Mood Disorders Center at the UC Neuroscience Institute. Michael Sorter, MD, will be leading the efforts at Cincinnati Children’s Hospital Medical Center and Christoph Correll, MD, will be leading efforts at Long Island Jewish.
Also today, Bin Huang, PhD, an associate professor in the UC Department of Pediatrics and a biostatistician in the Division of Biostatistics and Epidemiology at Cincinnati Children’s Hospital Medical Center, was approved for a $1.4 million PCORI grant to develop methods to make it easier and more efficient for patients with juvenile idiopathic arthritis, their families and their clinicians to determine which treatment to use next if a first-line therapy does not produce the desired response.
These projects are two of 34 awards totaling $120 million that PCORI approved today to fund patient-centered clinical comparative clinical effectiveness research (CER). All were approved by PCORI’s board pending completion of a business programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed health care decisions.
"We’re really excited to have this opportunity to systematically evaluate strategies to help children with bipolar spectrum illnesses improve their mental and physical health” says DelBello, who notes that the study will rely heavily on patient and community involvement and was inspired by John Hutton, MD, a professor of pediatrics at UC and associate dean for information services at the College of Medicine.
The study is titled "MOBILITY: Improving Patient-Centered Outcomes Among Overweight and Obese Youth with Bipolar Spectrum Disorders Treated with Second-Generation Antipsychotics.” It will assess whether healthy lifestyle interventions plus the diabetes drug metformin are more effective than lifestyle interventions alone in reducing weight gain and metabolic problems and improving the mental health of overweight and obese youth with bipolar disorders.
Studies have shown that patients with bipolar disorder are at greater risk than the general population for being overweight and obese, partly because of treatment with medications associated with weight gain.
"These treatments work, but unfortunately the side effects can include weight gain and we need to find a way to mitigate the high rates of obesity and improve treatment adherence,” says DelBello. "Designing the study was a group effort; we are fortunate to have the opportunity to partner with regional and national mental health facilities, including Lindner Center of HOPE (co-owned by UC Health and the Lindner Family Foundation), community mental health sites and agencies such as NAMI (National Alliance for Mental Illness) Southwest Ohio and the American Academy of Child and Adolescent Psychiatry.”
DelBello says the study will have a very strong biostatistical team, led by co-investigator Jeff Welge, PhD, a Department of Psychiatry and Behavioral Neuroscience faculty member who provides biostatistician expertise to the department.
MOBILITY will also leverage the resources of the Center for Clinical and Translational Science and Training (CCTST), including data collection and management using REDCap, a Web-based software platform.