Clinical trial NCT06450951: A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals
Official title: A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals Among a Child-Bearing Age Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Environmental Exposure
Keywords: phthalates
bisphenols
parabens
behavior change
Lead sponsor: Million Marker Wellness, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Renown Health
name: University of Nevada, Reno
First posted: 2024-06-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Changes in EDC metabolites after the intervention
timeFrame: Pre and post intervention (three months in between measurements)
Secondary outcomes:
measure: Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.
timeFrame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
measure: Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.
timeFrame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
measure: Changes in wellness after the intervention.
timeFrame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Other outcomes:
Locations:
city: Reno
country: United States
facility: Renown Health
state: Nevada
Study officials:
affiliation: Million Marker Wellness
name: Carol Kwaitkowski, PhD
role: STUDY_DIRECTOR
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