Pediatric Obesity Weight Evaluation Registry (POWER) Study
- Conditions
- OverweightObesity
- Registration Number
- NCT02121132
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
The main objective of this study is to establish a national pediatric obesity registry known as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical data from individual comprehensive pediatric weight management programs around the United States for overweight and obese youth.
- Detailed Description
All patients 18 years of age or younger who have completed an initial medical assessment between March 1, 2014 through April 30, 2020 will be approached for this study.
Data from individual follow up visits or group intervention sessions, depending on the program design of each institution, will be collected through October 31, 2020. The data included in this study will be collected during routine medical care. Information that could identify a participant will be removed from the data. Data will be entered into a secure database called Medidata Rave® CDMS. This database will be managed by the Data Coordinating Center (DCC) at Cincinnati Children's Hospital Medical Center (CCHMC).
The DCC will combine all the data from each site. Additional data cleaning and data quality monitoring will be performed. Combined datasets for analysis will be provided by the DCC in a format agreed upon by the POWER Governance Board. Data will be stored in a secure and protected format and will not include any written or electronic protected health information (PHI/EPHI). The DCC will store the data on a secure server.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4276
- age 18 years or younger
- overweight or obese patient
- initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
- no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess Patient Response to Weight Management Program 2 years This is a composite outcome measure that will be measured with changes in patient weight and BMI, fasting lipid profile, liver enzymes, fasting glucose and insulin, hemoglobin A1C and blood pressure.
- Secondary Outcome Measures
Name Time Method Measure Program Retention 2 years This will be measured by the number of visits and days that occur after the initial medical evaluation.
Trial Locations
- Locations (38)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
St. Luke's Children's Hospital
🇺🇸Boise, Idaho, United States
Our Lady of the Lake
🇺🇸Baton Rouge, Louisiana, United States
Marshfield Clinic
🇺🇸Wisconsin Rapids, Wisconsin, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Fit Kids of Arizona at Northern Arizona Healthcare
🇺🇸Cottonwood, Arizona, United States
Maine Medical Center - Barbara Bush Children's Hospital
🇺🇸Portland, Maine, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Riley Children's Hospital - IU Health
🇺🇸Indianapolis, Indiana, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Children's Medical Center at UT Southwestern
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
UCSF Benioff Children's Hospital Oakland
🇺🇸Oakland, California, United States
University of New Mexico Children's Hospital
🇺🇸Albuquerque, New Mexico, United States
Advocate Children's Hospital
🇺🇸Park Ridge, Illinois, United States
Penn State Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
University of Minnesota Amplatz Children's Hospital
🇺🇸Minneapolis, Minnesota, United States
Duke Children's Hospital & Health Center
🇺🇸Durham, North Carolina, United States
Mayo Clinic in Minnesota
🇺🇸Rochester, Minnesota, United States
Children's Hospital and Medical Center Omaha
🇺🇸Omaha, Nebraska, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Children's Hospital of San Antonio
🇺🇸San Antonio, Texas, United States
AdventHealth
🇺🇸Orlando, Florida, United States
University of Michigan C.S. Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
VCU Health
🇺🇸Richmond, Virginia, United States