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Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals in Adults of Child-Bearing Age

Sponsor
Million Marker Wellness, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05780047
Collaborator
(none)
220
Enrollment
1
Location
1
Arm
6
Actual Duration (Months)
36.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this intervention study is to determine to what extent the Million Marker (MM) program reduces users' endocrine disruption chemical (EDC) exposure levels and changes their environmental health awareness and behaviors. The main questions it aims to answer are:

  • Can the investigators see a reduction in EDC levels in participants' urine samples after using the MM Detect and Detox kit?

  • Can the investigators see a change in participants' environmental health literacy, knowledge, and behaviors after using MM's products and services?

  • How can Million Marker improve their app and platform to improve the user experience? Participants will collect their urine pre- and post-intervention, and will take a comprehensive exposure survey (via the MM app) before sending back their samples. This exposure survey will ask about participant's product use, diet, and lifestyle behaviors. Participants will also fill out surveys pre- and post-intervention assessing their perception of environmental health, as well as usability of the platform.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Mail-in Urine Test for EDCs
 N/A

Detailed Description

Exposures to endocrine disrupting chemicals (EDCs) have been linked to chronic diseases and conditions including breast cancer, metabolic syndrome, diabetes, and infertility. Timing of exposure, especially during pregnancy, may have a lifelong impact on the fetus, including neurodevelopmental problems and asthma. However, there have been no tools to allow those in the preconception, conception, and pregnancy stages to assess EDC exposures to ensure a healthy pregnancy and normal child development. Million Marker (MM) was born to fill this need. MM is a precision health company, built by a team of multidisciplinary scientists who are trained in environmental epidemiology, toxicology, analytical chemistry, biostatistics, data engineering, and business. MM's missions are to crowdsource and scale the biomonitoring of environmental chemicals and provide actionable results to consumers in a timely manner in order to empower individuals to proactively assess, track, and reduce their harmful environmental exposures. Starting with a few biomarkers of common EDCs, MM's ultimate vision is to discover all possible ("a million") biomarkers of harmful exposures to inform and improve individual health outcomes and advance precision medicine. Less than a year after it was founded, Million Marker developed and sold the first product-a mail-in urine test for BPA and phthalates-and successfully helped users reduce exposures through personalized intervention plans. Customers are able to order a test kit online, receive the test kit via mail, take a comprehensive exposure survey (via the Million Marker app), send back samples via mail, view personalized reports with tailored product recommendations through a secure online portal, make lifestyle changes to reduce exposures, and retest to monitor progress. MM's initial target audience are individuals of reproductive age, due to the vulnerability pregnancy and preconception to EDC exposures. However, it is unclear to what extent the MM platform educates, motivates, and ultimately reduces EDC exposure in individuals in this age range. Therefore, the aims of the current proposal are to 1) test and validate a this first-of-its-kind mobile EDC reduction program in a prospective longitudinal cohort intervention trial; 2) assess changes in participants' environmental health literacy, attitudes, knowledge, and behaviors after using MM's products and services; and 3) evaluate the MM app and platform usability to improve the user experience. Validating this population with MM's program is a step towards these types of future studies. At the conclusion of the project, MM will be well-positioned to begin Phase II and will scale the EDCs testing and personalized intervention plan to fertility clinics and the general public.

Study Design

Study Type:
Interventional
Actual Enrollment :
220 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals (EDCs) in Women of Child-Bearing Age and Their Partners
Actual Study Start Date :
May 1, 2022
Actual Primary Completion Date :
Oct 31, 2022
Actual Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mobile EDC reduction program

Million Marker's (MM) first-of-its-kind mobile endocrine disrupting chemical (EDC) reduction program will be tested and validated in a prospective longitudinal cohort intervention trial. 50 women in reproductive age and their partners will be recruited from the Healthy Nevada Project, an existing state-wide health monitoring effort. Using MM's services, participants' urine samples will be collected two times (at pre- and post-intervention) to measure changes in EDC levels. Changes in participants' environmental health literacy, attitudes, knowledge, and behaviors will be assessed after using MM's products and services. Validated surveys on environmental health literacy and readiness to change and analyses of participants' lifestyle behaviors and product use will be conducted at baseline (first test) and upon completion of the second test. The investigators will evaluate the MM app and platform usability to improve the user experience, using the System Usability Score (SUS) survey.

Diagnostic Test: Mail-in Urine Test for EDCs
Million Marker provides a mail-in urine test for Bisphenol A (BPA) and phthalates. Users take a comprehensive exposure survey (via the MM app), send back their samples, view their personalized reports with tailored product recommendations, make changes to reduce their exposures, and retest to monitor their progress. Participants will also fill out surveys to assess changes in their environmental health literacy, readiness to change, and analyses of lifestyle behaviors and product use.
Other Names:
  • Million Marker Detect and Detox test kit

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in endocrine disrupting chemical (EDC) levels [Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention]

      Urine samples collected pre- and post-intervention to measure changes in EDC levels

    Secondary Outcome Measures

    1. Changes in environmental health literacy using the Environmental Literacy Survey [Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention]

      Validated survey on environmental health literacy will be conducted at baseline and upon completion of the second test. The surveys will be compared for changes.

    2. Changes in readiness to change using the Readiness to Change Survey [Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention]

      Validated survey on readiness to change will be conducted at baseline and upon completion of the second test. The surveys will be compared for changes.

    3. Changes in digital health literacy using the Digital Health Literacy Instrument [Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention]

      Validated survey on digital health literacy will be conducted at baseline and upon completion of the second test. The surveys will be compared for changes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ages 18-40 years

    • in good health, not pregnant, free from diabetes or known kidney disease or cancer (these conditions may interfere with EDC metabolism)

    • able to understand written and spoken English

    • already consented for re-contact with the Healthy Nevada Project

    • owning a smartphone

    • willing to complete all study assessments

    Exclusion Criteria:
    • only one woman and her partner per household will be enrolled

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Million Marker Wellness Inc. Berkeley California United States 94704

    Sponsors and Collaborators

    • Million Marker Wellness, Inc.

    Investigators

    • Principal Investigator: Jenna Hua, PhD, Million Marker Wellness, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Million Marker Wellness, Inc.
    ClinicalTrials.gov Identifier:
    NCT05780047
    Other Study ID Numbers:
    • 1R43ES034312-01
    First Posted:
    Mar 22, 2023
    Last Update Posted:
    Mar 24, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Million Marker Wellness, Inc.
    parabens
    exposure
    environment

    Study Results

    No Results Posted as of Mar 24, 2023