Log In Now

Staff Login Current Patients

About the Study

Why is This Research Being Done?

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

This study involves children and teens ages 8-19 years who are overweight with certain mood disorders and who may start or are currently taking a second-generation antipsychotic.  Weight gain is a significant concern in this patient population.  See recent survey results for more information.

Research Study Facts

This study is being conducted by Dr. Melissa DelBello from the University of Cincinnati in collaboration with Long Island Jewish Hospital and Cincinnati Childrens' Hospital Medical Center. This study is being funded by PCORI (Patient-Centered Outcomes Research Institute; Award # PCS-1406-19276). Approximately 1800 youth will be taking part in this study at 24 public and private mental health practices in the Greater Cincinnati and New York City regions. Study length for each patient is 2 years.

See the Study Promotional Flyer

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:

Bipolar Child

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

Participating Sites

Cincinnati Area

  • Butler Behavioral Health Services
  • Central Clinic
  • The Children’s Home of Cincinnati
  • Cincinnati Children’s Hospital Medical Center
  • Lighthouse Youth Services
  • NECCO
  • St. Aloysius
  • St. Joseph Orphanage
  • Talbert House

Map and Contact Info of all Cincinnati sites

 

New York City Area

  • Zucker Hillside Hospital
  • South Oaks Hospital
  • North Shore Child & Family Guidance Center
  • Maimonides Medical Center
  • The Child Center of New York
  • Mount Sinai Health System
  • SUNY Downstate/Kings County Hospital Center
  • Nassau University Medical Center
  • New York City Children's Center
  • Stonybrook Medicine

Map and Contact Info of all New York City sites

Partners

Northwell

Contact Us

Or send us an e-mail at mobilitystudy@uc.edu