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Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

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ClinicalTrials.gov Identifier: NCT02121132
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Helen DeVos Children's Hospital
Mayo Clinic
Duke University
National Association of Children's Hospitals and Related Institutions (NACHRI)
Penn State Hershey Children's Hospital
UNM Children's Hospital
University of Illinois College of Medicine at Peoria
Children's Hospital Los Angeles
Connecticut Children's Medical Center
The Children's Hospital of San Antonio
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Mercy Hospital Kansas City
Arkansas Children's Hospital Research Institute
Florida Hospital for Children
UCSF Benioff Children’s Hospital Oakland
University of Oklahoma
Barbara Bush Children's Hospital at Maine Medical Center
Seattle Children's Hospital
Eastern Maine Medical Center
University of Florida
University of California, Los Angeles
Gramercy Pediatrics
St. Louis Children's Hospital
Children's Hospital at Dartmouth (CHaD) Pediatric Lipid and Weight Management Center
University of Alabama at Birmingham
University of Oklahoma-Tulsa
Fit Kids of Arizona
University of Kentucky
Orlando Health/Arnold Palmer Hospital Center for Digestive Health and Nutrition
Cleveland Clinic Children's
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date April 21, 2014
First Posted Date April 23, 2014
Last Update Posted Date March 21, 2019
Study Start Date May 2014
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02121132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 22, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Obesity Weight Evaluation Registry (POWER) Study
Official Title Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be overweight and obese patients (18 years of age or younger) who are seen for an initial medical evaluation in a pediatric weight management program from March 1, 2014 through April 30, 2020.
Condition
  • Overweight
  • Obesity
Intervention Not Provided
Study Groups/Cohorts No treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 22, 2014)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • no exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shelley Kirk, PhD, RD, LD 513-636-4305 Shelley.Kirk@cchmc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02121132
Other Study ID Numbers 2013-7127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators
  • Helen DeVos Children's Hospital
  • Mayo Clinic
  • Duke University
  • National Association of Children's Hospitals and Related Institutions (NACHRI)
  • Penn State Hershey Children's Hospital
  • UNM Children's Hospital
  • University of Illinois College of Medicine at Peoria
  • Children's Hospital Los Angeles
  • Connecticut Children's Medical Center
  • The Children's Hospital of San Antonio
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Children's Mercy Hospital Kansas City
  • Arkansas Children's Hospital Research Institute
  • Florida Hospital for Children
  • UCSF Benioff Children’s Hospital Oakland
  • University of Oklahoma
  • Barbara Bush Children's Hospital at Maine Medical Center
  • Seattle Children's Hospital
  • Eastern Maine Medical Center
  • University of Florida
  • University of California, Los Angeles
  • Gramercy Pediatrics
  • St. Louis Children's Hospital
  • Children's Hospital at Dartmouth (CHaD) Pediatric Lipid and Weight Management Center
  • University of Alabama at Birmingham
  • University of Oklahoma-Tulsa
  • Fit Kids of Arizona
  • University of Kentucky
  • Orlando Health/Arnold Palmer Hospital Center for Digestive Health and Nutrition
  • Cleveland Clinic Children's
Investigators
Principal Investigator: Shelley Kirk, PhD, RD, LD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date March 2019