Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

All patients 18 years of age or younger who have completed an initial medical assessment between March 1, 2014 through August 31, 2015 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 February 28, 2016. 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.

Who is eligible to participate?

Inclusion Criteria: - age 18 years or younger - overweight or obese patient - initial medical evaluation in a pediatric weight management program between March 1, 2014-August 31, 2015. Exclusion Criteria: - no exclusion criteria

Last updated:

7/11/2014

NCT ID:

NCT02121132

IRB Number:

14-000508