Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:22 AM
Study NCT ID:
NCT07461857
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minority-focused Environmental Health Education and Tracking (MEET) Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.', 'timeFrame': 'Measured before the intervention, after the intervention (1 months after baseline), and at follow-up (1 months after the intervention)', 'description': 'This surveys assesses EDC-specific environmental health literacy, based on questions in a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) or 1 (never) to 5 (always). Responses will be reverse coded during analysis as needed so that higher numbers reflect positive outcomes (higher EDC-EHL).'}, {'measure': "Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.", 'timeFrame': 'Measured before the intervention, after the intervention (1 months after baseline), and at follow-up (1 months after the intervention)', 'description': 'The Readiness to Change question asks participants to choose the response (sentence) that most accurately describes their current efforts and interest in limiting their exposure to harmful chemicals. Responses will be coded from 1 to 5 with 5 reflecting greater readiness to reduce risky behaviors.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bisphenols', 'parabens', 'phthalates', 'endocrine disrupting chemicals', 'EDCs'], 'conditions': ['Environmental Exposure']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'U.S. Department of Health and Human Services. System Usability Scale (SUS)'}, {'pmid': '32128233', 'type': 'BACKGROUND', 'citation': 'Dugas M, Gao GG, Agarwal R. Unpacking mHealth interventions: A systematic review of behavior change techniques used in randomized controlled trials assessing mHealth effectiveness. Digit Health. 2020 Feb 20;6:2055207620905411. doi: 10.1177/2055207620905411. eCollection 2020 Jan-Dec.'}, {'type': 'BACKGROUND', 'citation': 'Ajzen, I. The theory of planned behavior. Organ. Behav. Hum. Decis. 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Environ Int. 2018 Feb;111:23-31. doi: 10.1016/j.envint.2017.11.011. Epub 2017 Nov 20.'}, {'pmid': '31376593', 'type': 'BACKGROUND', 'citation': 'Ghayda RA, Williams PL, Chavarro JE, Ford JB, Souter I, Calafat AM, Hauser R, Minguez-Alarcon L. Urinary bisphenol S concentrations: Potential predictors of and associations with semen quality parameters among men attending a fertility center. Environ Int. 2019 Oct;131:105050. doi: 10.1016/j.envint.2019.105050. Epub 2019 Jul 31.'}, {'pmid': '30400886', 'type': 'BACKGROUND', 'citation': 'Hwang S, Lim JE, Choi Y, Jee SH. Bisphenol A exposure and type 2 diabetes mellitus risk: a meta-analysis. BMC Endocr Disord. 2018 Nov 6;18(1):81. doi: 10.1186/s12902-018-0310-y.'}, {'pmid': '27760374', 'type': 'BACKGROUND', 'citation': 'Heindel JJ, Blumberg B, Cave M, Machtinger R, Mantovani A, Mendez MA, Nadal A, Palanza P, Panzica G, Sargis R, Vandenberg LN, Vom Saal F. Metabolism disrupting chemicals and metabolic disorders. Reprod Toxicol. 2017 Mar;68:3-33. doi: 10.1016/j.reprotox.2016.10.001. Epub 2016 Oct 17.'}, {'pmid': '29328875', 'type': 'BACKGROUND', 'citation': 'Hiatt RA, Brody JG. Environmental Determinants of Breast Cancer. Annu Rev Public Health. 2018 Apr 1;39:113-133. doi: 10.1146/annurev-publhealth-040617-014101. Epub 2018 Jan 12.'}], 'seeAlsoLinks': [{'url': 'https://www.ewg.org/apps/', 'label': 'Environmental Working Group. Healthy Living App.'}, {'url': 'https://silentspring.org/detox-me-app-tips-healthier-living', 'label': 'Silent Spring Institute. Detox Me.'}, {'url': 'https://thinkdirtyapp.com', 'label': 'Think Dirty'}, {'url': 'https://www.clearya.com/', 'label': 'Clearya'}, {'url': 'https://www.pewresearch.org/internet/fact-sheet/mobile/', 'label': 'Mobile Fact Sheet'}, {'url': 'https://www.apple.com/ios/app-store/.', 'label': 'App Store'}, {'url': 'https://play.google.com/store?hl=en_US', 'label': 'Google Play'}, {'url': 'https://millionmarker.com/', 'label': 'Million Marker'}, {'url': 'https://thinkmobiles.com/blog/how-much-cost-make-app/', 'label': 'How much does it cost to make an app?'}, {'url': 'https://zoom.us.', 'label': 'Zoom'}, {'url': 'https://www.qsrinternational.com/nvivo-qualitative-data-analysis-software/home.', 'label': 'Nvivo'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is identify educational material related to EDC exposures that is culturally appropriate for the black community and test the usability of the material. The main questions this study aims to answer are:\n\n1. identify problematic lifestyle behaviors and products in a minority population that may contribute to harmful exposures and subsequently determine the most effective and sustainable lifestyle recommendations to reduce exposures;\n2. develop culturally appropriate educational EDC EHL materials by collaborating with community groups and adapting from Million Marker's existing extensive online educational resources and recommendations;\n3. integrate developed educational materials and targeted recommendations in existing Million Marker platform and test the usability of the material using a cohort of 100 black community members.", 'detailedDescription': "Integrate and test the usability of MEET. Use design iteration process to integrate developed educational materials and targeted recommendations in existing Million Marker platform and test the usability of the material using a cohort of 100 black community members.\n\nThe education material and recommendations developed for this project updates/adds on to the current Million Marker educational platform. This updated platform, MEET will incorporate culturally-sensitive feedback for an African American population. MEET will utilize a friendly user interface, and multiple options for engagement and incorporation of science translation/education.\n\nThe investigators will use eligibility criteria to recruit additional study participants that are: a) aged 18 and older; b) able to understand written and spoken English; c) owning a smartphone; and d) willing to complete all study assessments. Recruitment will be assisted by BCI's community advisory board. Again, investigators will utilize existing BCI's network, mailing lists and social media promotion to recruit potential participants. The investigators expect to enroll approximately 50% women and 100% African American.\n\nThe feasibility and usability testing will be conducted virtually. Recruited and consented community members (n=100) will use the platform for 4 weeks. Pre and post surveys will completed at the beginning and after 4 weeks. Surveys will cover environmental health and internet literacy, health app use, readiness to change and perceived identity, product use and breast cancer risk. The survey results will identify gaps in user perception and awareness to inform our education and marketing strategies. The investigators hypothesize that participants' environmental health literacy, attitudes, knowledge and behaviors will change after using MEET and receiving their personalized recommendations. The changes in participants' behaviors will be compared and assessed by examining the changes in lifestyle behaviors and product use, which will be captured through participants' exposure journals. The investigators expect to see a reduction in using EDC containing products, touching receipts, using less plastics, etc. Participants will also fill out an adapted System Usability Score (SUS)79 to assess users' perception of usability of the platform. The investigators expect to obtain high SUS scores, and will address any deficiencies based on SUS results and user feedback. Follow up surveys will be compared in order to assess trends over time, and begin to incorporate user feedback and behavior into the platform. Information collected will also inform our Phase II grant and future research studies.\n\nThe investigators will assess changes in participants' environmental health literacy, attitudes, knowledge, and behaviors after using MEET. Summary statistics will be generated on participants' responses. Changes will be calculated based on paired values of individual responses. The investigators will analyze percentage changes by individual responses as well as response categories (attitude, knowledge and behaviors). A Chi-square goodness of fit test will be used for pre-post comparisons. For pre-post category comparisons within individual participants, the Wilcoxon rank-sum test will be used to compare the differences.\n\nThe expected sample size of 100 will provide sufficient power to detect a difference in participant behaviors and attitudes at baseline (before using MEET) and after using MEET."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as black\n* Have access to a smartphone or computer\n\nExclusion Criteria:\n\n* Do not identify as black\n* Do not have access to a smartphone or computer'}, 'identificationModule': {'nctId': 'NCT07461857', 'acronym': 'MEET', 'briefTitle': 'Minority-focused Environmental Health Education and Tracking (MEET) Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Million Marker Wellness, Inc.'}, 'officialTitle': 'Minority-focused Environmental Health Education and Tracking (MEET) Pilot Study', 'orgStudyIdInfo': {'id': '20252771'}, 'secondaryIdInfos': [{'id': '1R43MD018950-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R43MD018950-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Black Community Participants', 'description': 'Members of the black community', 'interventionNames': ['Behavioral: Education curriculum']}], 'interventions': [{'name': 'Education curriculum', 'type': 'BEHAVIORAL', 'description': 'A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.', 'armGroupLabels': ['Black Community Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Million Marker', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'Jayne Foley, MPPM, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Million Marker Wellness'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Starting six months after publication', 'ipdSharing': 'YES', 'accessCriteria': 'Researchers must submit an acceptable research plan (goals of the proposed research, the specific hypotheses to be examined, justification for research and methods), be affiliated with a recognized research institution, have demonstrated expertise in the area of the proposed research project, and receive independent approval from their governing institutional review board. Data will be available for use only to answer the specific question(s) indicated in the research plan. The researchers must provide a list of variable names and an outline of how research findings will be disseminated; and will be asked to sign a data-sharing agreement that commits to: 1) not attempt to identify any individual participant, 2) secure the data using appropriate software technology, 3) and destroy or return all data once analyses are complete. All final datasets will be de-identified. Final authorship on manuscripts will require review and approval by the Principal Investigators of this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Million Marker Wellness, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Environmental Health Scientist', 'investigatorFullName': 'Jenna Hua', 'investigatorAffiliation': 'Million Marker Wellness, Inc.'}}}}