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.
