Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:58 PM
Study NCT ID:
NCT03939494
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Weight for Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mary.banks@cchmc.org', 'phone': '513-636-2147', 'title': 'Mary Banks', 'organization': "Cincinnati Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Each patient was observed for adverse events over their 6 month enrollment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 2, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Low HDL Cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Successful implementation of a "bundle of program enhancements" by existing clinical staff within existing pediatric weight management programs. This success will be defined by ≥80% of randomized intervention group participants and their parent/guardian attending the individual program orientation prior to their initial medical assessment as part of the pediatric weight management program and completing the interactive remote follow-up encounters to achieve the 26 provider contact hours in combination with time spent at clinic visits over the 6 month treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Completing Six Month Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Completion of the 6 month treatment period will be tracked.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participation Rates in Clinic Visits and Group Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 6 months', 'description': 'Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who have baseline data'}, {'type': 'SECONDARY', 'title': 'Change in Percent of the 95th Percentile for Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-2.35', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.', 'unitOfMeasure': 'percent of 95th percentile for BMI', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention of telehealth vs standard of care for change in percent of 95th percentile for body mass index.'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.80', 'upperLimit': '1.6'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '0.85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in percent body fat (%).', 'unitOfMeasure': 'percentage of body fat', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'After 6 months of data collection, percent body fat calculations are compared between the two groups'}, {'type': 'SECONDARY', 'title': 'Skeletal Muscle Mass Improvement Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '2.0'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '-0.45', 'upperLimit': '1.85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in skeletal muscle mass (kg). An improvement will be indicated by an increase in skeletal muscle mass.', 'unitOfMeasure': 'kg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in skeletal muscle mass after 6 month treatment period in intervention vs control group'}, {'type': 'SECONDARY', 'title': 'Improvement in Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '8.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '8.0'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '8.0'}, {'value': '-6.0', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in systolic blood pressure and diastolic blood pressure from baseline to 6 month evaluation in intervention participants vs control group participants'}, {'type': 'SECONDARY', 'title': 'Improvement in Lab Values for Serum ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '4.5'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is the change in the lab value of ALT', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in ALT blood value from baseline to 6 month visit'}, {'type': 'SECONDARY', 'title': 'Change in Triglyceride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-21.0', 'upperLimit': '16.0'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in triglyceride levels from baseline to 6 months in intervention vs control group participants', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in triglyceride levels from baseline to 6 months in intervention vs control group participants'}, {'type': 'SECONDARY', 'title': 'Change in Hba1C Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.15', 'upperLimit': '0.15'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in Hba1C from baseline to 6 month visit in intervention vs control group', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in Hba1C from baseline to 6 month visit in intervention vs control group'}, {'type': 'SECONDARY', 'title': 'Change in Non-HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '5.0'}, {'value': '9.00', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.00', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '1.0'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '15.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants'}, {'type': 'SECONDARY', 'title': 'Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Attendance of participants in each group at 3 month follow up visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants remaining in study after baseline to 3 month follow up study period'}, {'type': 'SECONDARY', 'title': 'Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'OG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Attendance of participants in each group at 6 month follow up visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants remaining at study end point with some amount of data provided'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'FG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'preAssignmentDetails': 'One additional participant enrolled to make up for a lost to follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.\n\nTelehealth Encounter: Contact will be made with participants via Face Time or Skype.'}, {'id': 'BG001', 'title': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'BG000', 'lowerLimit': '12.5', 'upperLimit': '18.0'}, {'value': '14.8', 'groupId': 'BG001', 'lowerLimit': '12.2', 'upperLimit': '17.6'}, {'value': '14.8', 'groupId': 'BG002', 'lowerLimit': '12.2', 'upperLimit': '18.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-22', 'size': 519355, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-27T22:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2019-04-11', 'resultsFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-11', 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs', 'timeFrame': '6 months', 'description': 'Successful implementation of a "bundle of program enhancements" by existing clinical staff within existing pediatric weight management programs. This success will be defined by ≥80% of randomized intervention group participants and their parent/guardian attending the individual program orientation prior to their initial medical assessment as part of the pediatric weight management program and completing the interactive remote follow-up encounters to achieve the 26 provider contact hours in combination with time spent at clinic visits over the 6 month treatment period.'}, {'measure': 'Number of Participants Completing Six Month Treatment Period', 'timeFrame': '6 months', 'description': 'Completion of the 6 month treatment period will be tracked.'}], 'secondaryOutcomes': [{'measure': 'Participation Rates in Clinic Visits and Group Sessions', 'timeFrame': 'Baseline to 6 months', 'description': 'Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.'}, {'measure': 'Change in Percent of the 95th Percentile for Body Mass Index', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.'}, {'measure': 'Change in Percentage of Body Fat', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in percent body fat (%).'}, {'measure': 'Skeletal Muscle Mass Improvement Over Time', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in skeletal muscle mass (kg). An improvement will be indicated by an increase in skeletal muscle mass.'}, {'measure': 'Improvement in Systolic and Diastolic Blood Pressure', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).'}, {'measure': 'Improvement in Lab Values for Serum ALT', 'timeFrame': '6 months', 'description': 'The health outcome to be evaluated is the change in the lab value of ALT'}, {'measure': 'Change in Triglyceride', 'timeFrame': '6 months', 'description': 'Change in triglyceride levels from baseline to 6 months in intervention vs control group participants'}, {'measure': 'Change in Hba1C Levels', 'timeFrame': '6 months', 'description': 'Change in Hba1C from baseline to 6 month visit in intervention vs control group'}, {'measure': 'Change in Non-HDL Cholesterol', 'timeFrame': '6 months', 'description': 'Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants'}, {'measure': 'Change in Fasting Glucose', 'timeFrame': '6 months', 'description': 'Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants'}, {'measure': 'Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.', 'timeFrame': '3 months', 'description': 'Attendance of participants in each group at 3 month follow up visit'}, {'measure': 'Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.', 'timeFrame': '6 months', 'description': 'Attendance of participants in each group at 6 month follow up visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'POWER is uniquely positioned to evaluate characteristics of multi-component PWM programs that are associated with "favorable" health outcomes for treatment-seeking youth with obesity. The POWER Data Coordinating Center developed ranking reports of the 33 participating sites based on weight status change at 6 months. An in-depth review of program design of 4 "top-performing" sites was conducted. A unique feature identified was offering an individual program orientation session to patient-families prior to the start of the multi-component PWM program. This orientation helped patient-families better understand the program\'s expectations, and offered an opportunity to evaluate readiness to change, barriers for making lifestyle changes, and mental health problems. This information was used to tailor the intervention to better meet the needs of participating patient-families. When a survey of program characteristics was conducted of the 33 participating sites, this "top-performing site" was the only one to offer such a program orientation session prior to patient-families starting the PWM program. Therefore this program feature was included as part of the "bundle of program enhancements" (BPE) for this proposed pragmatic pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 12 years of age and \\< 18\n* Scheduled for a new patient clinic visit at the multi-component PWM program at CCHMC or HDVCH\n* Severe obesity (≥ 120% of the 95th percentile for BMI based on age and gender at time of screening visit)\n* Able to understand and complete the consent process\n* Have access to a smart phone, device, or computer with a web camera\n* Have access to the internet\n\nExclusion Criteria:\n\n* Lacking capacity to provide informed consent\n* Non-English speaking\n* Participating in any other weight management program or research study related to weight management\n* Have a sibling participating in any other weight management program or research study related to weight management\n* Taking anti-obesity medication (Phentermine, Orlistat, Qsymia, Naltrxone-Bupropion, Lorcaserin, others at the discretion of the PI)'}, 'identificationModule': {'nctId': 'NCT03939494', 'briefTitle': 'Healthy Weight for Teens', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot', 'orgStudyIdInfo': {'id': '2018-4028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth Intervention', 'description': 'This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.', 'interventionNames': ['Behavioral: Telehealth Encounter']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Control', 'description': 'This arm will participate in their normal clinic/program routine.'}], 'interventions': [{'name': 'Telehealth Encounter', 'type': 'BEHAVIORAL', 'description': 'Contact will be made with participants via Face Time or Skype.', 'armGroupLabels': ['Telehealth Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Indiana', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.02005, 'lon': -86.72889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': "Helen DeVos Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}