Pediatric Obesity Weight Evaluation Registry (POWER) Study

Obesity Clinical Trial

— POWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02121132
• Other study ID #: 2013-7127
• Status: Recruiting
• Start date: May 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Shelley Kirk, PhD, RD, LD
• Phone: 513-636-4305
• Email: Shelley.Kirk[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pediatric Obesity

Locations

Country	Name	City	State
United States	University of New Mexico Children's Hospital	Albuquerque	New Mexico
United States	University of Michigan C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Dell Children's Medical Center	Austin	Texas
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Our Lady of the Lake	Baton Rouge	Louisiana
United States	St. Luke's Children's Hospital	Boise	Idaho
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Fit Kids of Arizona at Northern Arizona Healthcare	Cottonwood	Arizona
United States	Children's Medical Center at UT Southwestern	Dallas	Texas
United States	Duke Children's Hospital & Health Center	Durham	North Carolina
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Penn State Hershey Children's Hospital	Hershey	Pennsylvania
United States	Riley Children's Hospital - IU Health	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Florida Health Science Center	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of Minnesota Amplatz Children's Hospital	Minneapolis	Minnesota
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Children's Hospital and Medical Center Omaha	Omaha	Nebraska
United States	AdventHealth	Orlando	Florida
United States	Advocate Children's Hospital	Park Ridge	Illinois
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Maine Medical Center - Barbara Bush Children's Hospital	Portland	Maine
United States	VCU Health	Richmond	Virginia
United States	Mayo Clinic in Minnesota	Rochester	Minnesota
United States	Children's Hospital of San Antonio	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington
United States	Marshfield Clinic	Wisconsin Rapids	Wisconsin

Sponsors (31)

Lead Sponsor

Collaborator

Children's Hospital Medical Center, Cincinnati

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

Country where clinical trial is conducted

United States, 

References & Publications (8)

Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. doi: 10.1542/peds.102.3.e29. — View 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. — View Citation

Daniels SR, Greer FR; Committee on Nutrition. Lipid screening and cardiovascular health in childhood. Pediatrics. 2008 Jul;122(1):198-208. doi: 10.1542/peds.2008-1349. — View Citation

Krebs NF, Himes JH, Jacobson D, Nicklas TA, Guilday P, Styne D. Assessment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S193-228. doi: 10.1542/peds.2007-2329D. — View Citation

National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available. — View Citation

Ogden CL, Carroll MD, Curtin LR, Lamb MM, Flegal KM. Prevalence of high body mass index in US children and adolescents, 2007-2008. JAMA. 2010 Jan 20;303(3):242-9. doi: 10.1001/jama.2009.2012. Epub 2010 Jan 13. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Patient Response to Weight Management Program	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	Measure Program Retention	This will be measured by the number of visits and days that occur after the initial medical evaluation.	2 years