Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-29 @ 12:08 PM
Study NCT ID:
NCT07197216
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-12
First Post:
2025-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Tap Trust Intervention on Water Security Experiences and Beverage Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in child total plain water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Child total plain water intake assessed via validated beverage frequency questionnaires'}], 'secondaryOutcomes': [{'measure': 'Change in child unfiltered tap water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Child unfiltered tap water intake via validated beverage frequency questionnaires'}, {'measure': 'Change in child filtered tap water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Child filtered tap water intake via validated beverage frequency questionnaires'}, {'measure': 'Change in child bottled water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Child bottled water intake via validated beverage frequency questionnaires'}, {'measure': 'Change in child sugar-sweetened beverages (SSB) intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Child SSB intake via validated beverage frequency questionnaires'}, {'measure': 'Change in parent/caregiver total plain water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Parent/caregiver total plain water intake assessed via validated beverage frequency questionnaires'}, {'measure': 'Change in parent/caregiver unfiltered tap water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Parent/caregiver unfiltered tap water intake via validated beverage frequency questionnaires'}, {'measure': 'Change in parent/caregiver filtered water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Parent/caregiver filtered water intake via validated beverage frequency questionnaires'}, {'measure': 'Change in parent/caregiver bottled water intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Parent/caregiver bottled water intake via validated beverage frequency questionnaires'}, {'measure': 'Change in parent/caregiver SSB intake (oz/day)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Parent/caregiver SSB intake via validated beverage frequency questionnaires'}, {'measure': 'Change in parent/caregiver experience of home water security', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Parent/caregiver-reported experiences using home tap water, including ratings of taste, odor, appearance, and smell from questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drinking water quality', 'Child beverage intake', 'Preschoolers'], 'conditions': ['Beverage Intake', 'Child Health and Nutrition']}, 'descriptionModule': {'briefSummary': "The primary aim of this clinical trial is to determine whether the Tap Trust intervention increases water intake among preschool-aged children and their parents/caregivers by improving families' experiences with their home tap water."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Parents/caregivers of pre-school aged children from the Healthy Drinks, Healthy Futures study childcare centers that did not receive the program.\n2. Parents/caregivers must speak English or Spanish.\n3. Parents/caregivers of preschool-age children who don't have health conditions that preclude intake of water.\n\nExclusion Criteria:\n\nParents/caregivers who do not meet the inclusion criteria"}, 'identificationModule': {'nctId': 'NCT07197216', 'briefTitle': 'Evaluation of the Tap Trust Intervention on Water Security Experiences and Beverage Intake', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of the Tap Trust Intervention on Water Security Experiences and Beverage Intake', 'orgStudyIdInfo': {'id': '74926'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants will test their home tap water using kits mailed to their homes, with phone or Zoom assistance from the research team. Families with water quality concerns will receive remediation tailored to the issue (e.g., flushing guidance, filtration device and installation guidance). Participants will also receive reusable water bottles, educational handouts and videos, and phone or Zoom sessions with the research team that include motivational interviewing to set healthy beverage goals.', 'interventionNames': ['Behavioral: Tap Trust']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will not receive water testing kits, filtration devices, or educational resources during the study. After the study concludes, participants will have access to the intervention materials.'}], 'interventions': [{'name': 'Tap Trust', 'type': 'BEHAVIORAL', 'description': 'Home-based intervention includes tap water testing kits (instructions provided with videos or phone/Zoom), filtration devices if water quality concerns are identified, reusable water bottles and educational materials (handouts and videos), and phone/Zoom sessions with the research team using motivational interviewing.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305-5119', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Anisha I Patel, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This will need to be discussed with the community advisory board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Anisha I Patel', 'investigatorAffiliation': 'Stanford University'}}}}