Pediatric Obesity Weight Evaluation Registry (POWER) Study

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT02121132
Collaborator
Helen DeVos Children's Hospital (Other), Mayo Clinic (Other), Duke University (Other), National Association of Children's Hospitals and Related Institutions (NACHRI) (Other), Milton S. Hershey Medical Center (Other), University of New Mexico (Other), University of Illinois College of Medicine at Peoria (Other), Children's Hospital Los Angeles (Other), Connecticut Children's Medical Center (Other), The Children's Hospital of San Antonio (Other), Ann & Robert H Lurie Children's Hospital of Chicago (Other), Children's Mercy Hospital Kansas City (Other), Arkansas Children's Hospital Research Institute (Other), Florida Hospital for Children (Other), UCSF Benioff Children's Hospital Oakland (Other), University of Oklahoma (Other), MaineHealth (Other), Seattle Children's Hospital (Other), Eastern Maine Medical Center (Other), University of Florida (Other), University of California, Los Angeles (Other), Gramercy Pediatrics (Other), St. Louis Children's Hospital (Other), Dartmouth-Hitchcock Medical Center (Other), University of Alabama at Birmingham (Other), University of Tulsa (Other), Northern Arizona Healthcare (Other), University of Kentucky (Other), Arnold Palmer Hospital for Children (Other), The Cleveland Clinic (Other)
10,000
28
122
357.1
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 RaveĀ® 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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 1, 2014
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    No treatment

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Measure Program Retention [2 years]

      This will be measured by the number of visits and days that occur after the initial medical evaluation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Children's Hospital Little Rock Arkansas United States 72202
    2 Children's Hospital Los Angeles Los Angeles California United States 90027
    3 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    4 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    5 University of Florida Health Science Center Jacksonville Florida United States 32206
    6 Florida Hospital for Children Orlando Florida United States 32803
    7 Children's Healthcare of Atlanta Atlanta Georgia United States 30322
    8 St. Luke's Children's Hospital Boise Idaho United States 83702
    9 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60640
    10 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    11 Eastern Maine Medical Center Bangor Maine United States 04402
    12 Maine Medical Center - Barbara Bush Children's Hospital Portland Maine United States 04101
    13 University of Michigan C.S. Mott Children's Hospital Ann Arbor Michigan United States 48109
    14 Helen DeVos Children's Hospital Grand Rapids Michigan United States 49503
    15 University of Minnesota Amplatz Children's Hospital Minneapolis Minnesota United States 55454
    16 Mayo Clinic in Minnesota Rochester Minnesota United States 55905
    17 University of Mississippi Medical Center Jackson Mississippi United States 39216
    18 Children's Mercy Hospital Kansas City Missouri United States 64108
    19 University of New Mexico Children's Hospital Albuquerque New Mexico United States 87131
    20 Duke Children's Hospital & Health Center Durham North Carolina United States 27704
    21 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    22 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    23 Penn State Hershey Children's Hospital Hershey Pennsylvania United States 17033
    24 Dell Children's Medical Center Austin Texas United States 78723
    25 Children's Medical Center at UT Southwestern Dallas Texas United States 75390
    26 Cook Children's Medical Center Fort Worth Texas United States 76104
    27 Children's Hospital of San Antonio San Antonio Texas United States 78207
    28 Seattle Children's Hospital Seattle Washington United States 98105

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati
    • Helen DeVos Children's Hospital
    • Mayo Clinic
    • Duke University
    • National Association of Children's Hospitals and Related Institutions (NACHRI)
    • Milton S. Hershey Medical Center
    • University of New Mexico
    • 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
    • MaineHealth
    • Seattle Children's Hospital
    • Eastern Maine Medical Center
    • University of Florida
    • University of California, Los Angeles
    • Gramercy Pediatrics
    • St. Louis Children's Hospital
    • Dartmouth-Hitchcock Medical Center
    • University of Alabama at Birmingham
    • University of Tulsa
    • Northern Arizona Healthcare
    • University of Kentucky
    • Arnold Palmer Hospital for Children
    • The Cleveland Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02121132
    Other Study ID Numbers:
    • 2013-7127
    First Posted:
    Apr 23, 2014
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Children's Hospital Medical Center, Cincinnati
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2022