- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461857
Minority-focused Environmental Health Education and Tracking Pilot Study (MEET)
Minority-focused Environmental Health Education and Tracking (MEET) Pilot Study
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:
- 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;
- 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;
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
The 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.
The 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.
The 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.
The 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94704
- Million Marker
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identify as black
- Have access to a smartphone or computer
Exclusion Criteria:
- Do not identify as black
- Do not have access to a smartphone or computer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Black Community Participants
Members of the black community
|
A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.
Time Frame: Measured before the intervention, after the intervention (1 months after baseline), and at follow-up (1 months after the intervention)
|
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).
|
Measured before the intervention, after the intervention (1 months after baseline), and at follow-up (1 months after the intervention)
|
|
Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.
Time Frame: Measured before the intervention, after the intervention (1 months after baseline), and at follow-up (1 months after the intervention)
|
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.
|
Measured before the intervention, after the intervention (1 months after baseline), and at follow-up (1 months after the intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jayne Foley, MPPM, MPH, Million Marker Wellness
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20252771
- 1R43MD018950-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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