Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-29 @ 8:57 PM
Study NCT ID:
NCT06074159
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2023-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of Clinician-Mediated Report-Back
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "All study participants in two pregnancy cohorts will get a personal exposure report for chemicals measured during their pregnancy. 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive in-clinic to measure differences in participants' environmental health literacy. Pre-and post-tests are administered before and after report-back."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Environmental health literacy as measured by pre-and post-tests (questionnaires).', 'timeFrame': '2 weeks', 'description': '2 weeks after completing a pre-test and receiving their personal results, study participants will take a post-test. Pre-and post-tests include true and false, as well as scale questions that measure shifts in environmental health literacy before and after report-back.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'The study trains clinicians to return personal exposure results to study participants in pregnancy cohorts, and measures outcomes for environmental health literacy for both clinicians and study participants.', 'detailedDescription': 'To design and implement clinic-based report-back for endocrine disrupting compounds and analyze the impacts of doing so, investigators train clinicians to report-back individual chemical results to study participants in two pregnancy cohorts and then evaluate outcomes for both clinicians and patients, including shifts in environmental health behaviors, using interviews and pre-and post-tests. All study participants will get a personal exposure report and 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive them in-clinic to measure additional benefits of clinical report-back for participant learning, exposure-related behaviors, and relationships to the study and clinical care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants are of reproductive age\n\nExclusion Criteria:\n\n* Under 18 years old or past reproductive age'}, 'identificationModule': {'nctId': 'NCT06074159', 'briefTitle': 'Impacts of Clinician-Mediated Report-Back', 'organization': {'class': 'OTHER', 'fullName': 'Silent Spring Institute'}, 'officialTitle': 'Expanding Effective Report-back of Environmental Exposures in Clinic-Based Studies', 'orgStudyIdInfo': {'id': '1R21ES032934-01A1b'}, 'secondaryIdInfos': [{'id': '1R21ES032934-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21ES032934-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'In-clinic report-back', 'description': '200 participants receive their personal exposure results from a clinician', 'interventionNames': ['Behavioral: In-clinic report-back']}, {'type': 'OTHER', 'label': 'Online', 'description': '200 participants receive their personal exposure results from a website online', 'interventionNames': ['Behavioral: In-clinic report-back']}], 'interventions': [{'name': 'In-clinic report-back', 'type': 'BEHAVIORAL', 'description': 'Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors', 'armGroupLabels': ['In-clinic report-back', 'Online']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard T.H Chan School of Public Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '00936', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico Medical Sciences Campus', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Jennifer Ohayon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Silent Spring Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silent Spring Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Puerto Rico', 'class': 'OTHER'}, {'name': 'Northeastern University', 'class': 'OTHER'}, {'name': 'Harvard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}