Clinical trial NCT02121132: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Keywords: Overweight
Obesity
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Helen DeVos Children's Hospital
name: Mayo Clinic
name: Duke University
name: National Association of Children's Hospitals and Related Institutions (NACHRI)
name: Milton S. Hershey Medical Center
name: University of New Mexico
name: University of Illinois College of Medicine at Peoria
name: Children's Hospital Los Angeles
name: Connecticut Children's Medical Center
name: The Children's Hospital of San Antonio
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Children's Mercy Hospital Kansas City
name: Arkansas Children's Hospital Research Institute
name: Florida Hospital for Children
name: UCSF Benioff Children's Hospital Oakland
name: University of Oklahoma
name: MaineHealth
name: Seattle Children's Hospital
name: Eastern Maine Medical Center
name: University of Florida
name: University of California, Los Angeles
name: Gramercy Pediatrics
name: St. Louis Children's Hospital
name: Dartmouth-Hitchcock Medical Center
name: University of Alabama at Birmingham
name: University of Tulsa
name: Northern Arizona Healthcare
name: University of Kentucky
name: Arnold Palmer Hospital for Children
name: The Cleveland Clinic
First posted: 2014-04-23
Enrollment: 4276
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Assess Patient Response to Weight Management Program
timeFrame: 2 years
Secondary outcomes:
measure: Measure Program Retention
timeFrame: 2 years
Other outcomes:
Locations:
city: Cottonwood
country: United States
facility: Fit Kids of Arizona at Northern Arizona Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Jacksonville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Boise
country: United States
facility: St. Luke's Children's Hospital
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Children's Hospital
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Hospital - IU Health
state: Indiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Portland
country: United States
facility: Maine Medical Center - Barbara Bush Children's Hospital
state: Maine
city: Ann Arbor
country: United States
facility: University of Michigan C.S. Mott Children's Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Amplatz Children's Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital and Medical Center Omaha
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Children's Hospital
state: New Mexico
city: Durham
country: United States
facility: Duke Children's Hospital & Health Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Children's Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center at UT Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: San Antonio
country: United States
facility: Children's Hospital of San Antonio
state: Texas
city: Richmond
country: United States
facility: VCU Health
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Wisconsin Rapids
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Shelley Kirk, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Schwimmer JB, Deutsch R, Rauch JB, Behling C, Newbury R, Lavine JE. Obesity, insulin resistance, and other clinicopathological correlates of pediatric nonalcoholic fatty liver disease. J Pediatr. 2003 Oct;143(4):500-5. doi: 10.1067/S0022-3476(03)00325-1.
citation: Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
citation: Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.
citation: Kumar S, King EC, Christison AL, Kelly AS, Ariza AJ, Borzutzky C, Cuda S, Kirk S; POWER Work Group. Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. J Pediatr. 2019 May;208:57-65.e4. doi: 10.1016/j.jpeds.2018.12.049. Epub 2019 Mar 8.
citation: Gross AC, Kaizer AM, Kelly AS, Rudser KD, Ryder JR, Borzutzky CR, Santos M, Tucker JM, Yee JK, Fox CK; POWER Work Group. Long and Short of It: Early Response Predicts Longer-Term Outcomes in Pediatric Weight Management. Obesity (Silver Spring). 2019 Feb;27(2):272-279. doi: 10.1002/oby.22367.