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

项目总结/文摘

Project Summary/Abstract 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. Tools and services are urgently needed to allow individuals to learn about their personal EDC exposures and how to reduce them. Million Marker (MM) is a precision health company that was formed to fill this need. Our mission is 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 exposures and live a healthier lifestyle. Starting with a few biomarkers of common EDCs, our ultimate vision is to discover all possible (“a million”) biomarkers of EDC exposure to inform and improve individual health outcomes and advance precision medicine. MM is uniquely capable of carrying out this mission, with our team of multidisciplinary scientists who are highly trained in environmental epidemiology, toxicology, analytical chemistry, biostatistics, data engineering, and business. In Phase I of this study, we developed and tested the FIRST mobile EDC intervention service (app and exposure report-back) for its efficacy in increasing EH literacy (EHL), readiness to reduce exposures (i.e. readiness to change, RtC), and system usability among reproductive-age participants recruited from the Healthy Nevada Project (HNP), one of the largest population health cohorts in the world. We found a general trend of decreased EDC exposure with the intervention, as well as increased RtC. However, some participants did not increase their RtC and had difficulty carrying out the intervention on their own (which resulted in 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. Therefore, in this Phase II proposal, we 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). We plan to develop an EDC-specific online intervention curriculum (Aim 1); test the effectiveness of our intervention programs (Aim 2); and determine changes in EDC exposure before and after each intervention program (Aim 3). For Aim 1, we will recruit 15 men and 15 women of child-bearing age from HNP, our Phase I collaborator to participate in the intervention. For Aims 2 and 3, we will recruit and randomize 300 women and 300 men of reproductive age (total n=600) from HNP. Our target population is adult men and women of reproductive age (18-44 years old), who are also our target population (as stated in our Commercialization Plan). At the conclusion of this project, we will be well-positioned to begin Phase IIB and will scale our products and services to clinics and the general public, with the eventual aims of FDA approval, insurance coverage, and incorporation into routine clinical care.