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

March 21, 2024 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Cottonwood, Arizona, United States, 86326
        • Recruiting
        • Fit Kids of Arizona at Northern Arizona Healthcare
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Principal Investigator:
          • Wendy Ward, PhD
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • Claudia Borzutzky, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:
      • Oakland, California, United States, 94609
        • Recruiting
        • UCSF Benioff Children's Hospital Oakland
        • Principal Investigator:
          • June Tester, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Principal Investigator:
          • Elizabeth Estrada, MD
    • Florida
      • Jacksonville, Florida, United States, 32206
        • Recruiting
        • University of Florida Health Science Center
        • Principal Investigator:
          • Madeline Joseph, MD
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta
        • Principal Investigator:
          • Stephanie Walsh, MD
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • St. Luke's Children's Hospital
        • Principal Investigator:
          • Mindy Gaddis, MD, FAAP
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Principal Investigator:
          • Helen Binns, MD, MPH
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Advocate Children's Hospital
        • Contact:
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Principal Investigator:
          • Amy Christison, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Hospital - IU Health
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • Maine
      • Bangor, Maine, United States, 04402
        • Recruiting
        • Eastern Maine Medical Center
        • Principal Investigator:
          • Valerie O'Hara, DO
      • Portland, Maine, United States, 04101
        • Recruiting
        • Maine Medical Center - Barbara Bush Children's Hospital
        • Principal Investigator:
          • Michael Dedekian, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan C.S. Mott Children's Hospital
        • Principal Investigator:
          • Susan Woolford, MD
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital
        • Principal Investigator:
          • Jared Tucker, PhD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota Amplatz Children's Hospital
        • Principal Investigator:
          • Claudia Fox, MD, MPH
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Minnesota
        • Principal Investigator:
          • Seema Kumar, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Whitney Herrings, PD, MPH
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Principal Investigator:
          • Sarah Hampl, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Children's Hospital
        • Principal Investigator:
          • Sylvia Negrete, MD
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Recruiting
        • Duke Children's Hospital & Health Center
        • Principal Investigator:
          • Sarah Armstrong, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • Shelley Kirk, PhD, RD, LD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Ashley Weedn, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Hershey Children's Hospital
        • Principal Investigator:
          • Ronald Williams, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • The Medical University of South Carolina
        • Contact:
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center
        • Principal Investigator:
          • Stephen Pont, MD
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Children's Medical Center at UT Southwestern
        • Principal Investigator:
          • Jon Oden, MD
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center
        • Principal Investigator:
          • Alejandro de la Torre, MD
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Children's Hospital of San Antonio
        • Principal Investigator:
          • Susan Kuda, MD
    • Virginia
    • Washington
      • Seattle, Washington, United States, 98105
        • Completed
        • Seattle Children's Hospital
    • Wisconsin
      • Wisconsin Rapids, Wisconsin, United States, 54449
        • Recruiting
        • Marshfield Clinic
        • Principal Investigator:
          • Anoop Iqbal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Mayo Clinic
University of California, Los Angeles
University of Alabama at Birmingham
University of Oklahoma
The Cleveland Clinic
Duke University
University of Florida
Milton S. Hershey Medical Center
Seattle Children's Hospital
Dartmouth-Hitchcock Medical Center
Ann & Robert H Lurie Children's Hospital of Chicago
University of Kentucky
Children's Mercy Hospital Kansas City
Children's Hospital Los Angeles
St. Louis Children's Hospital
University of New Mexico
UCSF Benioff Children's Hospital Oakland
University of Tulsa
Arkansas Children's Hospital Research Institute
University of Illinois College of Medicine at Peoria
MaineHealth
Connecticut Children's Medical Center
Helen DeVos Children's Hospital
Florida Hospital for Children
Arnold Palmer Hospital for Children
Eastern Maine Medical Center
The Children's Hospital of San Antonio
National Association of Children's Hospitals and Related Institutions (NACHRI)
Gramercy Pediatrics
Northern Arizona Healthcare

Investigators

  • Principal Investigator: Shelley Kirk, PhD, RD, LD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimated)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-7127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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