Funding expands UC research into weight gain side effects of bipolar medication

Funding expands UC research into weight gain side effects of bipolar medication

Five-state initiative promotes metformin and healthy lifestyle interventions in youth

University of Cincinnati researchers have been approved for funding by the Patient-Centered Outcomes Research Institute (PCORI) to expand the implementation of healthy lifestyle interventions and metformin prescription to help manage weight gain in overweight or obese youth taking second-generation antipsychotic medications (SGAs).

SGAs are commonly used to treat youth living with mood, autism and psychotic disorders. Although these medications work well to help manage symptoms of these disorders, they are associated with significant weight gain, which is linked to long-term health problems and a negative impact on weight satisfaction, relationships with friends and overall quality of life. Weight gain is also the most common reason youth stop taking an SGA.

Led by UC's Melissa DelBello, MD, and Christina Klein, PhD, the project aims to broadly implement these interventions for youth prescribed an SGA at academic and community mental health centers in Ohio, Kentucky, Massachusetts, New York and Pennsylvania.

"The overall goal is to increase the number of SGA-treated youth (aged 8 to 19) with overweight/obesity who are offered metformin and healthy lifestyle education to manage weight gain," said DelBello, the Dr. Stanley and Mickey Kaplan endowed chair and professor of the Department of Psychiatry and Behavioral Neuroscience in UC's College of Medicine.

The MOBILITY study tested the effectiveness of the drug metformin and healthy lifestyle changes to prevent or reduce weight gain in youth taking medication to treat bipolar disorder. Photo/DuckyCards/iStock.

This project will focus on implementing findings from the MOBILITY study, PCORI-funded comparative clinical effectiveness research (CER) showing the effectiveness of treatment with metformin and distribution of healthy lifestyle intervention on reducing body mass index (BMI) compared with distribution of healthy lifestyle intervention alone after six months and two years.

Metformin is a medication that can help with managing weight gain and help people feel full after eating. The lifestyle intervention included a brief, eight-minute video and online/printed materials about a healthy eating and exercise plan.

MOBILITY showed that metformin and healthy lifestyle instruction in "real-life" settings had positive effects on weight that lasted for two years in SGA-treated youth, with the results published in The Lancet Psychiatry in 2025. Findings from MOBILITY are consistent with those of other recent studies as well as several recently published clinical best practice guidelines.

"Youth treated with SGAs, their caregivers and their doctors can use these results to help manage their weight and overall health," said Klein, assistant professor in UC's Department of Psychiatry and Behavioral Neuroscience in the College of Medicine. "We intend to provide youth and their caregivers with opportunities to learn about metformin and healthy lifestyle education and participate in treatment planning around weight management by accessing online educational patient-centered video and materials."

Melissa DelBello, MD

The team will also implement clinical support tools within electronic health records and hold on-site and online training to educate prescribers and clinic staff about the importance of monitoring weight and height in SGA-treated youth, how to identify which patients should be offered metformin and lifestyle instruction, how to prescribe metformin, and how to track outcomes over time.

"Importantly, youth and caregivers have been involved in shaping both the MOBILITY study and this implementation award and will be partnering with us over the course of the project to assure that all outcomes are patient-centered and relevant and do not cause undue burden," DelBello said.

Even the most impactful findings from clinical research studies can take years to make it into widespread clinical practice. This PCORI-funded project is focused on cutting that lag time and smoothing the path to uptake.

"In addition to funding patient-centered comparative clinical effectiveness research, PCORI funds implementation projects like this one to support the use of findings from PCORI-funded research in clinical practice," said PCORI Executive Director Nakela L. Cook, MD. "By implementing evidence addressing a key gap in care for youth prescribed second-generation antipsychotic medications, this project has the potential to improve patient outcomes and healthcare delivery. We look forward to following the project's progress."

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This funding award has been approved pending completion of PCORI's business and programmatic review and issuance of a formal award contract.

PCORI is a nonprofit organization with a mission to fund patient-centered CER designed to provide patients and those who care for them with evidence to make better-informed healthcare decisions.

Featured illustration at top of a doctor discussing medication with a mother and son. Photo/Drazen_/iStock Photo.

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