Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT02121132
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2014-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Obesity Weight Evaluation Registry (POWER) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4276}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2014-04-21', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess Patient Response to Weight Management Program', 'timeFrame': '2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Measure Program Retention', 'timeFrame': '2 years', 'description': 'This will be measured by the number of visits and days that occur after the initial medical evaluation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '20071470', 'type': 'BACKGROUND', '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.'}, {'pmid': '9724677', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18596007', 'type': 'BACKGROUND', '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.'}, {'pmid': '18055652', 'type': 'BACKGROUND', '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.'}, {'pmid': '15286277', 'type': 'BACKGROUND', '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.'}, {'pmid': '14571229', 'type': 'BACKGROUND', '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.'}, {'pmid': '18055651', 'type': 'BACKGROUND', '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.'}, {'pmid': '18055654', 'type': 'BACKGROUND', '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.'}, {'pmid': '37971786', 'type': 'DERIVED', 'citation': 'Christison 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.'}, {'pmid': '30853195', 'type': 'DERIVED', '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.'}, {'pmid': '30677263', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nData 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).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or younger\n* overweight or obese patient\n* initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.\n\nExclusion Criteria:\n\n* no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02121132', 'acronym': 'POWER', 'briefTitle': 'Pediatric Obesity Weight Evaluation Registry (POWER) Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management', 'orgStudyIdInfo': {'id': '2013-7127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86326', 'city': 'Cottonwood', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fit Kids of Arizona at Northern Arizona Healthcare', 'geoPoint': {'lat': 34.73919, 'lon': -112.00988}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32206', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Science Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Children's Hospital", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': "Advocate Children's Hospital", 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Saint Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Riley Children's Hospital - IU Health", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Our Lady of the Lake', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '04402', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Eastern Maine Medical Center', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '04101', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': "Maine Medical Center - Barbara Bush Children's Hospital", 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "University of Michigan C.S. Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Helen DeVos Children's Hospital", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "University of Minnesota Amplatz Children's Hospital", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Hospital and Medical Center Omaha", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': "University of New Mexico Children's Hospital", 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duke Children's Hospital & Health Center", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Penn State Hershey Children's Hospital", 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Dell Children's Medical Center", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center at UT Southwestern", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Hospital of San Antonio", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU Health', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '54449', 'city': 'Wisconsin Rapids', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic', 'geoPoint': {'lat': 44.38358, 'lon': -89.81735}}], 'overallOfficials': [{'name': 'Shelley Kirk, PhD, RD, LD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': "Helen DeVos Children's Hospital", 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': "National Association of Children's Hospitals and Related Institutions (NACHRI)", 'class': 'UNKNOWN'}, {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'University of Illinois College of Medicine at Peoria', 'class': 'OTHER'}, {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, {'name': "The Children's Hospital of San Antonio", 'class': 'OTHER'}, {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, {'name': 'Florida Hospital for Children', 'class': 'OTHER'}, {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, {'name': 'University of Oklahoma', 'class': 'OTHER'}, {'name': 'MaineHealth', 'class': 'OTHER'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': 'Eastern Maine Medical Center', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Gramercy Pediatrics', 'class': 'OTHER'}, {'name': "St. Louis Children's Hospital", 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Tulsa', 'class': 'OTHER'}, {'name': 'Northern Arizona Healthcare', 'class': 'OTHER'}, {'name': 'University of Kentucky', 'class': 'OTHER'}, {'name': 'Arnold Palmer Hospital for Children', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}