Pediatric Obesity Weight Evaluation Registry (POWER) Study

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fit Kids of Arizona at Northern Arizona Healthcare, Cottonwood, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

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

Registry information

Official study title

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

Acronym: POWER

Important dates

Study start: 2014
Primary completion: 2024
Study completion: 2024
First posted: Apr 23, 2014
Registry last updated: Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed