MobilityStudy

About the Study

Why Was This Research Performed?

The purpose of this study was to determine if adding metformin to a healthy lifestyle program would help children and teens control weight gain caused by certain medications.

This study involved children and teens ages 8-19 years who were overweight with certain mood disorders and who started or were taking a second-generation antipsychotic at the first study visit. Weight gain was and is a significant concern in this patient population. More information here.

Research Study Facts

This study was conducted by the University of Cincinnati in collaboration with Northwell Health and Cincinnati Childrens' Hospital Medical Center. This study was funded by PCORI (Patient-Centered Outcomes Research Institute; Award # PCS-1406-19276). The study enrolled 1565 youth at 24 public and private mental health practices in the Greater Cincinnati and New York City regions. Study visits were completed from 2015 through 2022. Study length for each patient was up to 2 years.

See a TV segment about the study with a patient story (1 of 2)

See a TV segment about the study with a patient story (2 of 2; starts at 23:07 in video)

MOBILITY TEACH

A secondary study was offered to all participants of MOBILITY. This study was called MOBILITY TEACH (Telemedicine Enhanced Access during COVID-19 to Healthcare).

The purpose of MOBILITY TEACH was to understand how the COVID-19 pandemic impacted how youth received their care from their mental health providers, and how their schooling may have changed due to COVID-19.

Tweets by MOBILITY_Trial

Bipolar Disorder

What is Bipolar Disorder?

Bipolar Disorders are common mental illnesses defined by periods of mania and depression. With mania, or high moods, people may have high energy, excitement, irritability and sleeplessness. With depression, or low moods, people can experience sadness, anxiety and hopelessness.

Research studies suggest that these disorders most commonly begin during adolescence. Youth with Bipolar Disorders have poorer work and school functioning and poorer quality of life when compared to others who develop the illness later in life.

For more information please visit:

Study Interventions

Metformin

Metformin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of type II diabetes in youth 10 years of age and up. Metformin also decreases food intake in obese, non-diabetic individuals. Metformin is well tolerated and safe in youth. But like any drug, it has side effects. Some of the side effects are diarrhea, nausea, and vomiting, but these side effects usually decrease over time.

Metformin has previously been studied for reducing weight in youth treated with second generation antipsychotics, a common treatment for bipolar spectrum disorders. These studies suggest metformin treatment is possibly associated with lower weight.

More Information on Metformin
More Information on Metformin (Spanish)

Lifestyle Program

All patients enrolled in this study receive a healthy lifestyle program. This program gives recommendations about healthy eating and physical activity. Healthy lifestyle programs designed for youth may lead to weight loss in youth who struggle with weight control.

The healthy eating plan divides food into three categories: Green, Yellow and Red foods, like a traffic light. Healthy (Green) foods should be eaten regularly and high calorie (Red) foods should be eaten rarely. The physical activity plan includes a variety of moderate exercises with clear instructions and pictures. Watch the video below or follow the links for plan details.

VIDEO - Healthy Eating and Physical Activity Plan

Healthy Eating and Physical Activity Plan
Healthy Eating and Physical Activity Plan (Spanish)

For more information on healthy lifestyles please visit:
Cincinnati Children's Health Works