Clinical trial NCT05780047: Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals in Adults of Child-Bearing Age
Official title: Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals (EDCs) in Women of Child-Bearing Age and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocrine Disrupting Chemicals
Environmental Exposure
Health Literacy
Bisphenol A
Phthalate Exposure
Survey
Keywords: parabens
exposure
environment
Lead sponsor: Million Marker Wellness, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value.
timeFrame: Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention
Secondary outcomes:
measure: Changes in Environmental Health Literacy Using the Environmental Literacy Survey
timeFrame: 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.
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Million Marker Wellness Inc.
state: California
Study officials:
affiliation: Million Marker Wellness, Inc.
name: Jenna Hua, PhD
role: PRINCIPAL_INVESTIGATOR
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