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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

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
Overweight Obesity

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort
No treatment



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Shelley Kirk, PhD, RD, LD 513-636-4305 Shelley.Kirk@cchmc.org

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Locations
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United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Principal Investigator: Wendy Ward, PhD         
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Claudia Borzutzky, MD         
UCSF Benioff Children's Hospital Oakland Recruiting
Oakland, California, United States, 94609
Principal Investigator: June Tester, MD         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Principal Investigator: Elizabeth Estrada, MD         
United States, Florida
University of Florida Health Science Center Recruiting
Jacksonville, Florida, United States, 32206
Principal Investigator: Madeline Joseph, MD         
Florida Hospital for Children Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: Angela Fals, MD         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Stephanie Walsh, MD         
United States, Idaho
St. Luke's Children's Hospital Recruiting
Boise, Idaho, United States, 83702
Principal Investigator: Mindy Gaddis, MD, FAAP         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60640
Principal Investigator: Helen Binns, MD, MPH         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Principal Investigator: Amy Christison, MD         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04402
Principal Investigator: Valerie O'Hara, DO         
Maine Medical Center - Barbara Bush Children's Hospital Recruiting
Portland, Maine, United States, 04101
Principal Investigator: Michael Dedekian, MD         
United States, Michigan
University of Michigan C.S. Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Susan Woolford, MD         
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Jared Tucker, PhD         
United States, Minnesota
University of Minnesota Amplatz Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55454
Principal Investigator: Claudia Fox, MD, MPH         
Mayo Clinic in Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Seema Kumar, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Principal Investigator: Whitney Herrings, PD, MPH         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Sarah Hampl, MD         
United States, New Mexico
University of New Mexico Children's Hospital Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: Sylvia Negrete, MD         
United States, North Carolina
Duke Children's Hospital & Health Center Recruiting
Durham, North Carolina, United States, 27704
Principal Investigator: Sarah Armstrong, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Shelley Kirk, PhD, RD, LD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Ashley Weedn, MD         
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Ronald Williams, MD         
United States, Texas
Dell Children's Medical Center Recruiting
Austin, Texas, United States, 78723
Principal Investigator: Stephen Pont, MD         
Children's Medical Center at UT Southwestern Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Jon Oden, MD         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Alejandro de la Torre, MD         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Principal Investigator: Susan Kuda, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Lenna Liu, MD, PhD         
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)
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
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Principal Investigator: Shelley Kirk, PhD, RD, LD Children's Hospital Medical Center, Cincinnati

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02121132     History of Changes
Other Study ID Numbers: 2013-7127
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Overweight
Obesity
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms