Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05950620
Status:
RECRUITING
Last Update Posted:
2023-07-19
First Post:
2023-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bringing Weight Management Into the Primary Care Pediatric Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-17', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'Body weight in kg'}, {'measure': 'Change in body height', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'Body height in meters'}, {'measure': 'Change in BMI', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'BMI will be calculated using the formula: kg weight / m2 height. Will be in both absolute and percentile for age'}, {'measure': 'Impact on glucose control', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'Hemoglobin A1c levels'}, {'measure': 'Impact on fatty liver', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'Levels of liver enzymes ALT, AST'}, {'measure': 'Impact on lipid levels', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.'}], 'secondaryOutcomes': [{'measure': 'Patient follow-up metrics', 'timeFrame': 'Baseline to follow-up (1-3 years)', 'description': 'Patient clinical follow-up rate, medication adherence, and retention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.', 'detailedDescription': 'The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients in a general pediatrician's office internally in Portland, Oregon.", 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren with obesity (BMI \\> 30 kg/m2 or \\> 95th percentile) or in need of weight management of unwanted weight gain.\n\nExclusion Criteria:\n\nNone.'}, 'identificationModule': {'nctId': 'NCT05950620', 'briefTitle': 'Bringing Weight Management Into the Primary Care Pediatric Practice', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice', 'orgStudyIdInfo': {'id': 'IRB 24927'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': 'Pediatric patients with obesity or in need of weight management for unwanted weight gain.', 'interventionNames': ['Other: Medical obesity management.']}, {'label': 'Controls', 'description': 'Historic controls matched to the Intervention group on age, sex, and BMI percentile.'}], 'interventions': [{'name': 'Medical obesity management.', 'type': 'OTHER', 'description': 'Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susanne Purnell', 'role': 'CONTACT', 'email': 'spurnell@childrens-clinic.com', 'phone': '503-297-3371'}], 'facility': "The Children's Clinic", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Jonathan Q Purnell, MD', 'role': 'CONTACT', 'email': 'purnellj@ohsu.edu', 'phone': '503-494-1056'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study uses anonymized data. No IPD will be generated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'William H. Hurt Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan Purnell', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}