Personalized Biomonitoring for Reducing Environmental Exposures

(REED Trial)

Overseen By Chris Ribbens, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Million Marker Wellness, Inc.

Disqualifiers: Pregnancy, Diabetes, Kidney disease, Cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized biomonitoring and educational support can reduce exposure to harmful chemicals known as endocrine-disrupting chemicals (EDCs) found in urine. Participants will either receive EDC testing and feedback alone or additional educational resources, live coaching, and access to an online forum. The trial seeks not only to reduce EDC levels but also to enhance participants' understanding of environmental health and improve their readiness to make healthier choices. Individuals who are not pregnant, do not have diabetes or kidney disease, and can understand English may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to significant research on environmental health and personal well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this personalized biomonitoring and report-back intervention is safe?

Research shows that personalized health monitoring and feedback programs are generally safe for participants. These programs test for certain chemicals that can affect hormones, share the results with participants, and provide educational resources like online courses and discussion groups.

Previous studies have not reported any major negative effects. Since this program focuses on education and monitoring rather than medication, participants need not worry about side effects from chemicals. Participants usually find this type of program easy to handle.

Although this trial doesn't follow the usual phases, this educational approach is considered low-risk. Participants learn about their exposure to certain chemicals and how to reduce it, which can improve their overall well-being without adding new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores personalized biomonitoring to help reduce harmful environmental exposures. Unlike typical health interventions that offer general advice, this approach uses personalized data from EDC (endocrine-disrupting chemicals) testing to tailor feedback for each individual. One arm of the trial even includes an interactive online curriculum and access to live coaches, providing participants with a comprehensive and personalized educational experience. By focusing on individual data and personalized education, this trial aims to empower people with precise strategies to minimize their exposure to potentially harmful chemicals.

What evidence suggests that this trial's interventions could be effective for reducing EDC exposures?

Research has shown that personalized health tracking, combined with an educational program, can reduce exposure to chemicals that affect hormones. These chemicals, known as endocrine disruptors, interfere with the body's hormone systems. In this trial, participants in the Educational Intervention arm will receive both EDC testing and personalized report-back, along with a self-directed online interactive curriculum, access to live coaches, and an online forum. Early results suggest that personal exposure data and education encourage people to change their habits to lower these chemical levels in their bodies. Studies indicate that those who receive both testing and education better understand environmental health and are more likely to take steps to reduce their exposure. Combining testing, feedback, and educational support, such as online courses and coaching, proves more effective than just receiving test results, which is what participants in the Test Only arm will experience. ^{1 2 3 4 6}

Who Is on the Research Team?

Carol Kwaitkowski, PhD

Principal Investigator

Million Marker Wellness

Are You a Good Fit for This Trial?

This trial is for men and women of child-bearing age who are not pregnant, do not have diabetes, kidney disease or cancer, and can understand English. Participants must be willing to complete all study assessments.

Inclusion Criteria

I am not pregnant, do not have diabetes, kidney disease, or cancer, understand English, and am willing to complete all study tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo EDC testing and receive personalized report-back, engage in a self-directed online interactive curriculum with access to live coaches and an online forum

12 weeks

2 visits (in-person) for urine sample collection, ongoing online engagement

Follow-up

Participants are monitored for changes in EDC levels, readiness to change, and wellness

12 weeks

1 visit (in-person) for follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Biomonitoring and Report-back Intervention

Trial Overview The trial tests if a personalized report on EDC levels in urine combined with an educational program can reduce exposure to endocrine disruptors, boost understanding of environmental health, encourage protective behaviors, and improve well-being.

How Is the Trial Designed?

Group I: Educational Intervention Active Control 2 Interventions

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.

Group II: Test Only Active Control 1 Intervention

The test-only arm includes EDC testing and report-back.

Who Is Running the Clinical Trial?

Million Marker Wellness, Inc.

Lead Sponsor

Trials

2

Recruited

1,000+

Renown Health

Collaborator

Trials

5

Recruited

2,006,000+

University of Nevada, Reno

Collaborator

Trials

34

Recruited

20,200+

Published Research Related to This Trial

The Pediatric Quality of Life Inventory (PedsQL) showed strong responsiveness and predictive validity in a study of 4,637 pediatric patients, indicating it can effectively measure changes in health-related quality of life during hospital stays.

Patients with medically complex conditions had lower improvement scores on the PedsQL compared to those without chronic conditions, and lower admission scores were linked to higher risks of prolonged hospital stays and readmissions, highlighting its potential as a tool for assessing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting. Desai, AD., Zhou, C., Stanford, S., et al.[2022]

Biomonitoring is increasingly used to assess chemical exposure from both occupational and environmental sources, providing a comprehensive view of exposure through various absorption routes and considering individual differences in sensitivity.

Key challenges in biomonitoring include developing cost-effective methods for frequent monitoring, establishing specific guidance values for exposure biomarkers, and expanding the range of validated effect biomarkers to improve health assessments in the workplace.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance values for the biomonitoring of occupational exposure. State of the art. Aitio, A.[2015]

The Patient Health Questionnaire-9 item 9 identified a higher prevalence of suicidal risk (24%) compared to the Columbia Suicide Severity Rating Scale (C-SSRS) (6%) and clinical assessments (1.4%), indicating that the PHQ-9 may produce more false positives.

The C-SSRS demonstrated high sensitivity (95%) and specificity (95%) for identifying suicidal risk, suggesting it is a more reliable screening tool when combined with timely clinical assessments for effective follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Electronic Screening for Suicidal Risk With the Patient Health Questionnaire Item 9 and the Columbia Suicide Severity Rating Scale in an Outpatient Psychiatric Clinic. Viguera, AC., Milano, N., Laurel, R., et al.[2022]

Modern biomonitoring programs can now measure over 200 chemicals in our bodies, which may shift the focus from traditional exposure assessments to direct measurement of chemical concentrations in biological samples.

While biomonitoring provides valuable data on chemical exposure, it does not directly inform individuals about their health risks, highlighting the need for effective communication strategies to help the public understand these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomonitoring and biomarkers: exposure assessment will never be the same. Paustenbach, D., Galbraith, D.[2022]

The study highlights the issue of misclassification in determining patient responders in interventional studies due to the unreliable measurement of outcomes, which can lead to significant overestimation or underestimation of treatment effectiveness.

A new method is proposed to more accurately estimate the true proportion of responders, which can improve the reliability of results in both single and controlled study groups, enhancing the interpretation of patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Over- and Underestimation of Success Rates]. Höder, J., Eisemann, N., Hüppe, A.[2019]

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

In a study involving 84 healthy participants aged 60-69, wearable passive air samplers were used to monitor personal exposure to airborne chemicals over five months, revealing significant variations in exposure profiles.

The study identified three particularly toxic exposures—dichlorvos from insecticides, naphthalene from mothballs, and polyaromatic hydrocarbons—highlighting the potential health risks associated with common environmental chemicals and the effectiveness of wearable monitors in assessing exposure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the external exposome using wearable passive samplers - The China BAPE study. Koelmel, JP., Lin, EZ., Guo, P., et al.[2021]

Engaging adolescents and their caregivers in focus groups led to the development of effective report-back documents that clearly present personal air sampling results, including pollutant information and health risks.

The final report-back document was designed to be electronic and interactive, providing participants with personalized data visualizations and actionable strategies for reducing exposure to air pollution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant engagement to develop report-back materials for personal air monitoring. Ryan, PH., Wolfe, C., Parsons, A., et al.[2023]

The AMTRA system, a web-based tool for monitoring treatment-related toxicity in cancer patients, was used by 168 patients undergoing chemotherapy, resulting in over 31,000 toxicity registrations and enabling timely clinical interventions for severe symptoms.

Patients reported high compliance with oral chemotherapy at 98.7%, and many found the AMTRA system helpful for communication with healthcare providers and felt more in control of their treatment management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMTRA: a multicentered experience of a web-based monitoring and tailored toxicity management system for cancer patients. Rasschaert, M., Vulsteke, C., De Keersmaeker, S., et al.[2021]

Biomonitoring effectively measures the presence and concentration of chemicals in humans through blood, urine, or breath, providing valuable data on chemical exposure over time.

The review emphasizes the importance of careful interpretation of biomonitoring data, highlighting that while it establishes baseline exposure information, detection of chemicals does not necessarily equate to health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomonitoring: is body burden relevant to public health? Paustenbach, D., Galbraith, D.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06450951?term=%22environmental%20health%22%20OR%20%22environmental%20exposure%22&aggFilters=status:not%20rec&rank=1

Study Details | A Personalized Biomonitoring and Report ... The intervention includes EDC testing and exposure report-back, a self-directed online interactive curriculum with access to live coaches, and an online forum.

2. trialx.com trialx.com/clinical-trials/listings/316610/a-personalized-biomonitoring-and-report-back-intervention-to-reduce-exposure-to-endocrine-disrupting-chemicals/

A Personalized Biomonitoring and Report-back ... The goal of this clinical trial is to learn if a personalized biomonitoring report-back and educational intervention in child-bearing aged men ...

3. withpower.com withpower.com/trial/phase-environmental-exposures-5-2024-0e6c3

Personalized Biomonitoring for Reducing Environmental ... The intervention includes EDC testing and exposure report-back, a self-directed online interactive curriculum with access to live coaches, and an online forum.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11587698/

Reducing Exposures to Endocrine Disruptors (REED) study, a ... We will test and compare the effectiveness of 1) EDC exposure report-back (control), and 2) a self-directed online interactive curriculum of EDC ...

5. sbir.gov sbir.gov/awards/203297

Award | SBIR 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39587613/

Reducing Exposures to Endocrine Disruptors (REED) ... A personalized at-home intervention program to reduce exposure to endocrine disrupting chemicals among a child-bearing age cohort.