PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Bipolar disorder is a brain disorder that causes people to have periods of unstable moods. People with bipolar disorder may have problems focusing and sleep less than normal while feeling high energy. People with bipolar disorder may also feel sad or hopeless or want to hurt themselves. Bipolar disorder often begins during childhood or the teenage years.

Medicines called second-generation antipsychotics are used to treat bipolar disorder but can cause side effects, including weight gain. Youth and their parents find weight gain to be the most difficult side effect. Healthy eating, exercising, and other activities that encourage a healthy lifestyle may help patients avoid weight gain. Taking a medicine called metformin may also help control weight gain. However, researchers have only studied these weight control options for short time periods in controlled settings. This makes it hard to know whether these treatments will work over longer periods of time for patients treated outside of research settings.

This study looks at two ways to help manage weight gain and overall health in youth with bipolar disorder: using a program to help youth and families make healthy choices, or using that program along with metformin.

Who can this research help?

The results of this research may help overweight and obese youth with bipolar disorder prevent or manage weight gain.

What is the research team doing?

Researchers are recruiting 1,800 overweight or obese youth ages 8 to 19 years old who have bipolar disorder and take medicine that can cause weight gain. Researchers are recruiting these youth from 24 private and community mental health clinics in the Greater Cincinnati and New York City regions.

The researchers assign all youth in the study to use LIFE, a program that guides youth and their families in making healthy eating plans, exercising, and avoiding activities with little or no exercise. The research team is assigning half the youth in the study by chance to receive metformin in addition to this program. The research team is testing both options to see whether they improve weight change, blood pressure, blood sugar, and cholesterol. The team is also looking at how each treatment affects self-esteem, mood, and quality of life. Finally, the team is also looking at how often youth take their medicine and how satisfied youth are with their treatment.

Before the research project started, 497 patients, 344 caregivers, and 54 clinicians completed an online survey and gave their opinions on the study design. Patients, parents, and mental health advocates contribute to study decisions.

Research methods at a glance