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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Personalized Biomonitoring and Report-back Intervention?

Research indicates that technology-based interventions, like electronic tools for monitoring, can improve home-based care by providing reliable systems to track treatment-related issues. Additionally, providing feedback from patient-reported outcomes has been associated with improved care processes and patient outcomes, suggesting that personalized biomonitoring could be effective in reducing environmental exposures. ^{1 2 3 4 5}

How is the Personalized Biomonitoring and Report-back Intervention treatment different from other treatments for reducing environmental exposures?

This treatment is unique because it uses personalized biomonitoring to assess individual exposure to environmental chemicals and provides tailored feedback to participants, helping them understand and reduce their exposure. Unlike traditional methods, it combines personal exposure data with an interactive online curriculum to empower individuals to make informed decisions about their environmental health. ^{6 7 8 9 10}

Research Team

Carol Kwaitkowski, PhD

Principal Investigator

Million Marker Wellness

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

AMTRA: a multicentered experience of a web-based monitoring and tailored toxicity management system for cancer patients. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Over- and Underestimation of Success Rates]. [2019]

3. United States 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. [2022]

4. England 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. [2022]

5. Germany 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Biomonitoring: is body burden relevant to public health? [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Biomonitoring and biomarkers: exposure assessment will never be the same. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Exploring the external exposome using wearable passive samplers - The China BAPE study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Participant engagement to develop report-back materials for personal air monitoring. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

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