Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT04422951
Status:
TERMINATED
Last Update Posted:
2023-10-16
First Post:
2020-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tom.robinson@stanford.edu', 'phone': '(650) 723-5331', 'title': 'Thomas N. Robinson, MD, MPH', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study did not meet its planned enrollment and did not achieve statistical power.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 2.5 months, when participation ended.', 'eventGroups': [{'id': 'EG000', 'title': 'Education Plus Behavioral Rx', 'description': 'Participants receive health education plus a 6-month usual care behavioral intervention for weight control.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Body Mass Index From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Education Plus Behavioral Rx', 'description': 'Participants receive health education plus a 6-month usual care behavioral intervention for weight control.'}], 'timeFrame': 'Change from baseline to 6 months', 'description': 'body mass index = weight in kilograms divided by the squared height in meters', 'reportingStatus': 'POSTED', 'populationDescription': 'No participant had post-baseline BMI data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wise Interventions Plus Behavioral Rx', 'description': 'Participants receive Wise social psychological interventions (growth mindset and values self-affirmation) plus a 6-month usual care behavioral intervention for weight control.'}, {'id': 'FG001', 'title': 'Education Plus Behavioral Rx', 'description': 'Participants receive health education plus a 6-month usual care behavioral intervention for weight control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'To enter the study, the child and at least one parent/guardian must have agreed to participate, and both child and adult were considered to be enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Education Plus Behavioral Rx', 'description': 'Participants receive health education plus a 6-month usual care behavioral intervention for weight control.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-30', 'size': 338926, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-07T12:20', 'hasProtocol': True}, {'date': '2022-05-13', 'size': 173459, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-16T12:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Delays and complications due to the Covid pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2020-06-05', 'resultsFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-13', 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Mass Index From Baseline to 6 Months', 'timeFrame': 'Change from baseline to 6 months', 'description': 'body mass index = weight in kilograms divided by the squared height in meters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity randomized to receive the wise social psychological interventions plus a usual care behavioral intervention for weight management compared to children randomized to receive additional education plus a usual care behavioral intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10-16 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate\n\nExclusion Criteria:\n\n* Medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy\n\nMedications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone\n\nConditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason\n\nConditions limiting participation in the assessments - child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in his/her native language\n\nUnable to read, understand or complete informed consent in English or Spanish'}, 'identificationModule': {'nctId': 'NCT04422951', 'briefTitle': 'Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity', 'orgStudyIdInfo': {'id': '54341'}, 'secondaryIdInfos': [{'id': 'R01DK123286', 'link': 'https://reporter.nih.gov/quickSearch/R01DK123286', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wise interventions plus behavioral Rx', 'description': 'Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care behavioral intervention for weight control.', 'interventionNames': ['Behavioral: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education plus behavioral Rx', 'description': 'Health education plus a usual care behavioral intervention for weight control', 'interventionNames': ['Behavioral: Education plus usual care behavioral treatment']}], 'interventions': [{'name': 'Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment', 'type': 'BEHAVIORAL', 'description': 'Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care behavioral intervention for weight control in children with obesity', 'armGroupLabels': ['Wise interventions plus behavioral Rx']}, {'name': 'Education plus usual care behavioral treatment', 'type': 'BEHAVIORAL', 'description': '6-month health education plus usual care behavioral intervention for weight control in children with obesity', 'armGroupLabels': ['Education plus behavioral Rx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Thomas Robinson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Limited access data will be shared within six months of the publication date for the primary outcome publication or within two years of the date that the database is locked for analysis, whichever occurs first.', 'ipdSharing': 'YES', 'description': 'Data sharing will be based on the policy for data sharing issued by the NIH and consistent with HIPAA privacy standards. Our data management team will prepare de-identified public use data set from this study for deposition in a repository.', 'accessCriteria': 'User registration will be required. Users must agree to the conditions of use governing access to the public release data (a data use agreement), including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Thomas Robinson', 'investigatorAffiliation': 'Stanford University'}}}}