A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals (REED)

May 12, 2026 updated by: Jenna Hua, Million Marker Wellness, Inc.

A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals Among a Child-Bearing Age Cohort

The goal of this clinical trial is to learn if a personalized biomonitoring report-back and educational intervention in child-bearing aged men and women can reduce endocrine disrupting chemicals (EDCs) measured in urine, increase participants' understanding of environmental health (environmental health literacy; EHL), increase their readiness and behaviors to reduce exposures, and improve their well-being.

The intervention includes EDC testing and exposure report-back, a self-directed online interactive curriculum with access to live coaches, and an online forum. The investigators hypothesize that the intervention will be more effective than EDC testing and report-back alone at reducing EDC exposures (behavior change and metabolite concentrations), as well as increasing EHL, readiness to reduce exposures, and well-being.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Exposures to endocrine disrupting chemicals (EDCs) have been linked to chronic diseases, including breast cancer, metabolic syndrome, diabetes, and infertility. EDC-related health and economic burden is estimated to be $340 billion annually. Exposure during pregnancy may have a lifelong impacts on the fetus, including preterm birth, low birth weight, hypospadias, allergies, asthma and behavioral issues. Today, consumers can order genetic tests to find out about their health predispositions. However, genetics are unchangeable. There are few services that allow people to understand their environmental health (EH) in order to optimize health by changing their lifestyles. Consumers are becoming more aware of the hazardous effects of EDCs, and are calling for such services. Million Marker (MM), a consumer-focused science company, was created to fill this gap. MM aims to crowdsource the biomonitoring of environmental chemicals and increase EH awareness at individual and population levels. MM provides results in a timely manner so individuals can proactively assess, track, and reduce their exposures.

In Phase I of this study, MM developed and tested the FIRST mobile EDC intervention service (app and exposure report-back) for its efficacy in reducing EDC levels, increasing EH literacy (EHL), increasing readiness to reduce exposures (i.e. readiness to change, RtC), and assessing system usability among reproductive-age participants recruited from the Healthy Nevada Project (HNP), one of the largest population health cohorts in the world. A general trend of decreased EDC exposure with the intervention, as well as increased RtC was found. However, some participants did not increase their RtC and had difficulty carrying out the intervention on their own (with no decrease in EDC exposure). The reasons for these less optimal results were the difficulty in the EHL subject matter-participants still felt ill-prepared to apply their knowledge to making healthier lifestyle changes, and cited financial reasons and limited choices as barriers to change. Therefore, in this Phase II proposal, the investigators will address these perceived limitations by 1) developing and 2) testing a self-directed online interactive curriculum with live counseling sessions and individualized support modeled after the highly effective Diabetes Prevention Program (DPP) and Omada Health (which provides a digital interactive DPP).

MM plans to achieve this through three aims. Aim 1: Develop an EDC-specific online intervention curriculum leveraging the extensive experience in EDC research, curriculum development, and digitizing DPP from world experts. Following the format of DPP and using an iterative human-centered design process, investigators will test the program with a pilot group of 30 participants (15 males and 15 females) and evaluate it using the System Usability Score (SUS) measuring user engagement, satisfaction, and retention. Aim 2: Test the effectiveness of the intervention programs. Investigators will test and compare the effectiveness of (1) a mobile EDC reduction program (control, previously assessed in Phase I), and (2) a self-directed online interactive curriculum of EDC EHL material (treatment, developed in Aim 1) with personalized support. The investigators hypothesize that the self-directed online interactive curriculum with personalized support will be more effective (superior) than the mobile EDC reduction program at increasing EDC-specific EHL, readiness to reduce exposures, and well-being. These two arms will be tested in a longitudinal EDC randomized control trial (n=600). Participants (1:1 male to female) of reproductive age will be recruited from HNP, MMs Phase I collaborator and randomly assigned to one of the interventions. Outcomes for this aim will measure surveyed changes pre- post-interventions in EDC EHL, RtC, and well-being using the same validated instruments used in Phase I to assess the outcomes. Aim 3: Determine changes in EDC exposure before and after each intervention program. Using MMs existing EDC panel (used in Phase I, part of MM's current direct-to-consumer testing service) that tests for 13 chemical metabolites including BPA, BPA alternatives, phthalates, parabens and oxybenzone, participants' urine samples will be collected twice (at pre- and post-intervention) to measure changes in EDC levels. The investigators hypothesize that participants in the online intervention arms will have increased EDC-specific EHL and readiness to reduce exposures (i.e. RtC), a higher sense of well-being, and a greater reduction in EDC levels compared to the original intervention.

By developing, testing and improving this new intervention option, MM will be one step closer to product-market fit and offering a cost-effective service for reducing EDC exposures, increasing EHL/RtC, and improving well-being and clinical outcomes. As reflected in the support letters from OBGYNs and fertility clinics, patients are seeking such interventions and clinics are looking to offer these (paid) add-on services in order to optimize patients' fertility and differentiate from other clinics. If the aims are achieved, MM will be ready for Phase IIB and will begin to scale products and services to clinics and the general public, with the eventual aims of FDA approval, insurance coverage, and incorporation into routine clinical care.

Study Type

Interventional

Enrollment (Estimated)

600

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
    • Nevada
      • Reno, Nevada, United States, 89557
        • Renown Health

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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; and willing to complete all study assessments.

Exclusion Criteria:

-

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Educational Intervention
The educational intervention arm includes EDC testing and personalized report-back, a self-directed online interactive curriculum of EDC material, access to live coaches, and an online forum.
Diagnostic test: Urinary EDC metabolite testing
Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.
Behavioral: Educational curriculum
A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.
Active Comparator: Test Only
The test-only arm includes EDC testing and report-back.
Diagnostic test: Urinary EDC metabolite testing
Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in EDC metabolites after the intervention
Time Frame: Pre and post intervention (three months in between measurements)
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone
Pre and post intervention (three months in between measurements)

Secondary 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 (3 months after baseline), and at follow-up (3 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 (3 months after baseline), and at follow-up (3 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 (3 months after baseline), and at follow-up (3 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 (3 months after baseline), and at follow-up (3 months after the intervention)
Changes in wellness after the intervention.
Time Frame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Individual questions assess participants self-reported overall health, physical activity, sleep and stress.
Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)

Collaborators and Investigators

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

Sponsor

Million Marker Wellness, Inc.

Collaborators

University of Nevada, Reno
Renown Health

Investigators

  • Study Director: Carol Kwaitkowski, PhD, Million Marker Wellness

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 23, 2024

Primary Completion (Actual)

February 28, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2R44ES034312-02 (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 six 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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