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

April 18, 2024 updated by: Million Marker Wellness, Inc.

Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals (EDCs) in Women of Child-Bearing Age and Their Partners

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

434

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Million Marker Wellness Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value.
Time Frame: 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
Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Environmental Health Literacy Using the Environmental Literacy Survey
Time Frame: Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention. Change scores are reported as the post-intervention subscale score minus the baseline score.
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. The EHL survey was adapted from the "General Environmental Health Scale" and was titled "Environmental Health Literacy Scale" with three subscales: knowledge, attitudes, and behaviors. Knowledge and attitude responses ranged from strongly disagree (1) to strongly agree (5) and behavior responses ranged from never (1) to always (5). Scores were summed across 3 questions within each subscale resulting in a range of 3 (worse) to 15 (better) for each subscale.
Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention. Change scores are reported as the post-intervention subscale score minus the baseline score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Million Marker Wellness, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R43ES034312-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Million Marker will disseminate research results and findings to the scientific community through presentations at scientific meetings and conferences and publications in academic journals, as well as through the mass media and online postings. The Principal Investigator of this study will make data and associated documentation/metadata available to external researchers under a data-sharing agreement in which a specific commitment is made to use the data for research purposes only, to not provide the data to a third party or distribute it in any form, and to properly acknowledge the source of funding for the collection of the data and the researchers involved in this study.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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