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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 14, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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.

Study Design
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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 : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Groups and Cohorts
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Group/Cohort
No treatment


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Locations
Show Show 28 study locations
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
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Principal Investigator: Shelley Kirk, PhD, RD, LD Children's Hospital Medical Center, Cincinnati
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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    
Other Study ID Numbers: 2013-7127
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
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