Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 11:55 PM
Study NCT ID:
NCT07103356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Table-Top Water Pitcher to Reduce Arsenic Exposure Among Well Users in New Hampshire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020261', 'term': 'Arsenic Poisoning'}, {'id': 'D000069578', 'term': 'Waterborne Diseases'}], 'ancestors': [{'id': 'D020260', 'term': 'Heavy Metal Poisoning, Nervous System'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Water arsenic concentrations', 'timeFrame': '4 weeks', 'description': 'Changes in water arsenic concentrations from baseline to week 4'}, {'measure': 'Urinary arsenic concentrations', 'timeFrame': '4 weeks', 'description': 'Changes in urinary arsenic concentrations from baseline to week 4'}, {'measure': 'Reach', 'timeFrame': '4 weeks', 'description': 'Number of participants who receive the water pitcher filtration system among all eligible individuals and demographics'}, {'measure': 'Adoption', 'timeFrame': '4 weeks', 'description': 'Number of participants using the filtration system after receiving it; number of participants who intend to use the system after the study period ends; and demographics of participants who used the filtration system during the study period or intend to use it after the study period ends'}, {'measure': 'Implementation', 'timeFrame': '4 weeks', 'description': '% of participants who adhere to the intervention during the intervention period (Fidelity), including using the pitcher filtration system for all drinking and cooking water and changing filter cartridges as recommended (measured by questionnaire: at home, did you use the pitcher filtration system for all of your drinking water, more than half of your drinking water, half of your drinking water, less than half of your drinking water, or none of your drinking water AND did you use did you use the pitcher filtration system for all of your cooking water, more than half of your cooking water, half of your cooking water, less than half of your cooking water, or none of your cooking water)'}, {'measure': 'Maintenance', 'timeFrame': '8 weeks', 'description': '% of participants who continue to use the pitcher filtration system during the 8-week sustainability period when replacement filter cartridges are no longer provided (measured by questionnaire: at home, did you use the pitcher filtration system for all of your drinking water, more than half of your drinking water, half of your drinking water, less than half of your drinking water, or none of your drinking water AND did you use did you use the pitcher filtration system for all of your cooking water, more than half of your cooking water, half of your cooking water, less than half of your cooking water, or none of your cooking water)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arsenic', 'Private Well', 'Environmental Health', 'Filter'], 'conditions': ['Arsenic Poisoning', 'Environmental Exposure', 'Water-Related Diseases']}, 'descriptionModule': {'briefSummary': 'The goals of this clinical trial are to:\n\n1. gather preliminary data on the effectiveness of a table-top water pitcher filtration system in reducing arsenic exposure among individuals using private wells with elevated (\\>5 μg/L) arsenic concentrations, and\n2. identify the factors influencing implementation of the filter intervention (uptake and sustainability) and barriers and facilitators to its use.\n\nThe main questions it aims to answer are:\n\nDo water and urinary arsenic concentrations change from baseline to Week 4 of the water pitcher intervention?\n\nAre changes in arsenic concentrations maintained during the eight-week sustainability period?\n\n* Which factors facilitate or impede uptake, use, and sustainability of the intervention?\n* Are household income and/or home ownership associated with sustained filter use?\n\nParticipants will:\n\n* Receive a free 12-cup water filter pitcher and cartridge replacements\n* Use the pitcher filtration system, including replacement of filter cartridges, per manufacturer recommendations\n* Collect and mail water and urine samples at baseline, 4 weeks, and 12 weeks\n* Complete online questionnaires at baseline, 4 weeks, and 12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* NH resident\n* Receiving primary care at Dartmouth Hitchcock Clinics - Concord\n* Use a private water system as primary drinking water source\n* Do majority (\\>50%) of food preparation in home\n* Interested in receiving a free water arsenic test kit\n* Water arsenic \\>5 micrograms/L upon testing\n\nExclusion Criteria:\n\n* Use or plan to use a mitigation strategy to reduce exposure to arsenic-contaminated drinking water'}, 'identificationModule': {'nctId': 'NCT07103356', 'briefTitle': 'Table-Top Water Pitcher to Reduce Arsenic Exposure Among Well Users in New Hampshire', 'organization': {'class': 'OTHER', 'fullName': 'Trustees of Dartmouth College'}, 'officialTitle': 'Developing a Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial to Test a Table-Top Water Pitcher to Reduce Arsenic Exposure in Northern New England', 'orgStudyIdInfo': {'id': 'STUDY00033185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water Pitcher Filtration System', 'description': 'Arm 1: No reminders to change water pitcher filter cartridges Arm 2: Weekly reminders to change water pitcher filter cartridges', 'interventionNames': ['Behavioral: Water Pitcher Filtration System']}], 'interventions': [{'name': 'Water Pitcher Filtration System', 'type': 'BEHAVIORAL', 'description': 'Table-top water pitcher filtration system', 'armGroupLabels': ['Water Pitcher Filtration System']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caitlin Howe, PhD', 'role': 'CONTACT', 'email': 'caitlin.g.howe@dartmouth.edu', 'phone': '603-646-5419'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trustees of Dartmouth College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Epidemiology', 'investigatorFullName': 'Caitlin G. Howe', 'investigatorAffiliation': 'Trustees of Dartmouth College'}}}}