OverweightPOWERNCT02121132
Pediatric Obesity Weight Evaluation Registry (POWER) Study
An observational study of Overweight and Obesity, run by Children's Hospital Medical Center, Cincinnati at 38 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Overweight, Obesity
- How many people
- 4,276 participants
- Where
- 38 sitesUnited States
- Study dates
- May 2014to 28 Jun 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of New Mexico Children's Hospital
Albuquerque, New Mexico, 87131
University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Dell Children's Medical Center
Austin, Texas, 78723
Eastern Maine Medical Center
Bangor, Maine, 04402
Our Lady of the Lake
Baton Rouge, Louisiana, 70808
St. Luke's Children's Hospital
Boise, Idaho, 83702
The Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60640
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Fit Kids of Arizona at Northern Arizona Healthcare
Cottonwood, Arizona, 86326
Children's Medical Center at UT Southwestern
Dallas, Texas, 75390
Duke Children's Hospital & Health Center
Durham, North Carolina, 27704
Cook Children's Medical Center
Fort Worth, Texas, 76104
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Riley Children's Hospital - IU Health
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Florida Health Science Center
Jacksonville, Florida, 32206
Children's Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of California Los Angeles
Los Angeles, California, 90095
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, 55454
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Children's Hospital and Medical Center Omaha
Omaha, Nebraska, 68114
AdventHealth
Orlando, Florida, 32803
Advocate Children's Hospital
Park Ridge, Illinois, 60068
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Maine Medical Center - Barbara Bush Children's Hospital
Portland, Maine, 04101
VCU Health
Richmond, Virginia, 23298
Mayo Clinic in Minnesota
Rochester, Minnesota, 55905
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Seattle Children's Hospital
Seattle, Washington, 98105
Marshfield Clinic
Wisconsin Rapids, Wisconsin, 54449
About this study
Official title: Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Measure Program Retention
This will be measured by the number of visits and days that occur after the initial medical evaluation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,276 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Shelley Kirk, PhD, RD, LD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121132
- Sponsor's protocol ID
- 2013-7127
- Acronym
- POWER
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2014
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20071470Barlow 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.
PubMed 9724677Daniels 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.
PubMed 18596007Krebs 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.
PubMed 18055652National 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.
PubMed 15286277Schwimmer 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.
PubMed 14571229Barlow 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.
PubMed 18055651Spear 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.
PubMed 18055654Christison A, Tucker J, King E, Sweeney B, Cuda S, Frank M, Kirk S. Treating Children and Adolescents With Obesity: Characteristics of Success. Child Obes. 2024 Sep;20(6):416-424. doi: 10.1089/chi.2023.0083. Epub 2023 Nov 15.
PubMed 37971786Kumar 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.
PubMed 30853195Gross 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.
PubMed 30677263
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management
- ClinicalTrials.gov ID
- NCT02121132
- Acronym / sponsor ID
- POWER / 2013-7127
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,276 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- 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
- Study start
- May 2014 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Measure Program Retention
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 20071470Ogden 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.
- Background: PubMed 9724677Barlow 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.
- Background: PubMed 18596007Daniels 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.
- Background: PubMed 18055652Krebs 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.
- Background: PubMed 15286277National 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.
- Background: PubMed 14571229Schwimmer 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.
- Background: PubMed 18055651Barlow 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.
- Background: PubMed 18055654Spear 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.
- Derived from this study: PubMed 37971786Christison A, Tucker J, King E, Sweeney B, Cuda S, Frank M, Kirk S. Treating Children and Adolescents With Obesity: Characteristics of Success. Child Obes. 2024 Sep;20(6):416-424. doi: 10.1089/chi.2023.0083. Epub 2023 Nov 15.
- Derived from this study: PubMed 30853195Kumar 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.
- Derived from this study: PubMed 30677263Gross 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Kirk, PhD, RD, LD principal investigator
Children's Hospital Medical Center, Cincinnati
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Children's Hospital Medical Center, Cincinnati at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Patient Response to Weight Management Program (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121132, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.