Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02121132|
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : February 1, 2021
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
- Assess Patient Response to Weight Management Program [ Time Frame: 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.
- Measure Program Retention [ Time Frame: 2 years ]This will be measured by the number of visits and days that occur after the initial medical evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121132
|Contact: Shelley Kirk, PhD, RD, LD||513-636-4305||Shelley.Kirk@cchmc.org|
|Principal Investigator:||Shelley Kirk, PhD, RD, LD||Children's Hospital Medical Center, Cincinnati|