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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 Northwell Health 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/Midwest Area

  • Butler Behavioral Health Services
  • Central Clinic
  • Child Focus
  • The Children’s Home of Cincinnati
  • The Children's Home of Northern Kentucky
  • Cincinnati Children’s Hospital Medical Center
  • Nationwide Children's Hospital (Columbus, OH)
  • NECCO
  • Ohio State University Medical Center (Columbus, OH)
  • Samaritan Behavioral Health (Dayton, OH)
  • Seton Medical Center (Austin, TX)
  • South Community (Dayton, OH)
  • St. Aloysius Orphanage
  • St. Joseph Orphanage
  • Talbert House
  • TCN Family Solutions (Dayton, OH)
  • University of Cincinnati
  • University Hospital (Cleveland, OH)

Map and Contact Info of all Midwest sites

 

New York/East Coast Area

  • Albert Solnit Psychiatric Center (Middletown, CT)
  • The Child Center of New York
  • Children's Hospital of Philadelphia (Philadelphia, PA)
  • Graham Windham
  • Jersey Shore University Medical Center (Neptune, NJ)
  • Maimonides Medical Center
  • Massachusetts General Hospital (Boston, MA)
  • McLean Hospital (Boston, MA)
  • Mount Sinai Health System
  • Nassau University Medical Center
  • New York City Children's Center
  • North Shore Child & Family Guidance Center
  • NYU Medical Center
  • South Oaks Hospital
  • Stony Brook University Hospital (Stony Brook, NY)
  • SUNY Downstate/Kings County Hospital Center
  • University of Rochester (Rochester, NY)
  • Zucker Hillside Hospital

Map and Contact Info of all East Coast sites

Partners

Northwell

Contact Us

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