Environmental ExposureREEDNCT06450951
A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals
A study testing Urinary EDC metabolite testing and Educational curriculum in people with Environmental Exposure, run by Million Marker Wellness, Inc. at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Urinary EDC metabolite testing and Educational curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,074 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals Among a Child-Bearing Age Cohort
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.
Read the 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.
- Conditions
- Environmental Exposure
- Being tested
- Urinary EDC metabolite testing, Educational curriculum
- Keywords
- phthalates, bisphenols, parabens, behavior change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary EDC metabolite testingDiagnostic test
Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.
Educational curriculumBehavioural
A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Active comparator | 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. Receives: Diagnostic Test: Urinary EDC metabolite testing; Behavioral: Educational curriculum |
| Test Only | Active comparator | The test-only arm includes EDC testing and report-back. Receives: Diagnostic Test: Urinary EDC metabolite testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in concentration of EDC metabolites after the intervention
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone
Measured: Pre and post intervention (three months in between measurements)
Changes in score of Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.
This surveys assesses EDC-specific environmental health literacy, based on questions in a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) or 1 (never) to 5 (always). Responses will be reverse coded during analysis as needed so that higher numbers reflect positive outcomes (higher EDC-EHL).
Measured: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Secondary outcomes (4)
Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.
The Readiness to Change question asks participants to choose the response (sentence) that most accurately describes their current efforts and interest in limiting their exposure to harmful chemicals. Responses will be coded from 1 to 5 with 5 reflecting greater readiness to reduce risky behaviors.
Measured: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Changes in wellness after the intervention.
Individual questions assess participants self-reported overall health, physical activity, sleep and stress.
Measured: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Change in Blood Biomarkers
Blood biomarkers including A1C, Cholesterol, Glucose, CRP etc. from at home Siphox Blood Test measure before and after the intervention.
Measured: Pre and post intervention (three months in between measurements)
Changes in exposures
Changes in self reported product (personal-care products, household products) exposures, including number of products used and number of ingredients of concern in products used.
Measured: baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start23 May 2024
- Primary completion28 Feb 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,074 participants (actual)
Sponsor and investigators
- Lead sponsor
- Million Marker Wellness, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Renown Health, University of Nevada, Reno
- Responsible party
- Principal investigator, Jenna Hua, Million Marker Wellness, Inc.
- Investigators
- Carol Kwaitkowski, PhD, Study director, Million Marker Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450951
- Sponsor's protocol ID
- 2R44ES034312-02
- Acronym
- REED
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Million Marker will disseminate research results and findings to the scientific community through presentations at scientific meetings and conferences and publications in academic journals, as well as through the mass media and online postings. The Principal Investigator of this study will make data and associated documentation/metadata available to external researchers under a data-sharing agreement in which a specific commitment is made to use the data for research purposes only, to not provide the data to a third party or distribute it in any form, and to properly acknowledge the source of funding for the collection of the data and the researchers involved in this study.
Publications
Hiatt RA, Brody JG. Environmental Determinants of Breast Cancer. Annu Rev Public Health. 2018 Apr 1;39:113-133. doi: 10.1146/annurev-publhealth-040617-014101. Epub 2018 Jan 12.
PubMed 29328875Heindel JJ, Blumberg B, Cave M, Machtinger R, Mantovani A, Mendez MA, Nadal A, Palanza P, Panzica G, Sargis R, Vandenberg LN, Vom Saal F. Metabolism disrupting chemicals and metabolic disorders. Reprod Toxicol. 2017 Mar;68:3-33. doi: 10.1016/j.reprotox.2016.10.001. Epub 2016 Oct 17.
PubMed 27760374Hwang S, Lim JE, Choi Y, Jee SH. Bisphenol A exposure and type 2 diabetes mellitus risk: a meta-analysis. BMC Endocr Disord. 2018 Nov 6;18(1):81. doi: 10.1186/s12902-018-0310-y.
PubMed 30400886Ghayda RA, Williams PL, Chavarro JE, Ford JB, Souter I, Calafat AM, Hauser R, Minguez-Alarcon L. Urinary bisphenol S concentrations: Potential predictors of and associations with semen quality parameters among men attending a fertility center. Environ Int. 2019 Oct;131:105050. doi: 10.1016/j.envint.2019.105050. Epub 2019 Jul 31.
PubMed 31376593Machtinger R, Gaskins AJ, Racowsky C, Mansur A, Adir M, Baccarelli AA, Calafat AM, Hauser R. Urinary concentrations of biomarkers of phthalates and phthalate alternatives and IVF outcomes. Environ Int. 2018 Feb;111:23-31. doi: 10.1016/j.envint.2017.11.011. Epub 2017 Nov 20.
PubMed 29161633Attina TM, Hauser R, Sathyanarayana S, Hunt PA, Bourguignon JP, Myers JP, DiGangi J, Zoeller RT, Trasande L. Exposure to endocrine-disrupting chemicals in the USA: a population-based disease burden and cost analysis. Lancet Diabetes Endocrinol. 2016 Dec;4(12):996-1003. doi: 10.1016/S2213-8587(16)30275-3. Epub 2016 Oct 17.
PubMed 27765541Braun JM. Early-life exposure to EDCs: role in childhood obesity and neurodevelopment. Nat Rev Endocrinol. 2017 Mar;13(3):161-173. doi: 10.1038/nrendo.2016.186. Epub 2016 Nov 18.
PubMed 27857130Mustieles V, Zhang Y, Yland J, Braun JM, Williams PL, Wylie BJ, Attaman JA, Ford JB, Azevedo A, Calafat AM, Hauser R, Messerlian C. Maternal and paternal preconception exposure to phenols and preterm birth. Environ Int. 2020 Apr;137:105523. doi: 10.1016/j.envint.2020.105523. Epub 2020 Feb 29.
PubMed 32120140Woods MM, Lanphear BP, Braun JM, McCandless LC. Gestational exposure to endocrine disrupting chemicals in relation to infant birth weight: a Bayesian analysis of the HOME Study. Environ Health. 2017 Oct 27;16(1):115. doi: 10.1186/s12940-017-0332-3.
PubMed 29078782Veiga-Lopez A, Kannan K, Liao C, Ye W, Domino SE, Padmanabhan V. Gender-Specific Effects on Gestational Length and Birth Weight by Early Pregnancy BPA Exposure. J Clin Endocrinol Metab. 2015 Nov;100(11):E1394-403. doi: 10.1210/jc.2015-1724. Epub 2015 Sep 25.
PubMed 26406292Raghavan R, Romano ME, Karagas MR, Penna FJ. Pharmacologic and Environmental Endocrine Disruptors in the Pathogenesis of Hypospadias: a Review. Curr Environ Health Rep. 2018 Dec;5(4):499-511. doi: 10.1007/s40572-018-0214-z.
PubMed 30578470Gascon M, Casas M, Morales E, Valvi D, Ballesteros-Gomez A, Luque N, Rubio S, Monfort N, Ventura R, Martinez D, Sunyer J, Vrijheid M. Prenatal exposure to bisphenol A and phthalates and childhood respiratory tract infections and allergy. J Allergy Clin Immunol. 2015 Feb;135(2):370-8. doi: 10.1016/j.jaci.2014.09.030. Epub 2014 Oct 30.
PubMed 25445825Paciencia I, Cavaleiro Rufo J, Silva D, Martins C, Mendes F, Farraia M, Delgado L, de Oliveira Fernandes E, Padrao P, Moreira P, Severo M, Barros H, Moreira A. Exposure to indoor endocrine-disrupting chemicals and childhood asthma and obesity. Allergy. 2019 Jul;74(7):1277-1291. doi: 10.1111/all.13740. Epub 2019 Mar 5.
PubMed 30740706Kalkbrenner AE, Schmidt RJ, Penlesky AC. Environmental chemical exposures and autism spectrum disorders: a review of the epidemiological evidence. Curr Probl Pediatr Adolesc Health Care. 2014 Nov;44(10):277-318. doi: 10.1016/j.cppeds.2014.06.001. Epub 2014 Sep 5.
PubMed 25199954Oulhote Y, Lanphear B, Braun JM, Webster GM, Arbuckle TE, Etzel T, Forget-Dubois N, Seguin JR, Bouchard MF, MacFarlane A, Ouellet E, Fraser W, Muckle G. Gestational Exposures to Phthalates and Folic Acid, and Autistic Traits in Canadian Children. Environ Health Perspect. 2020 Feb;128(2):27004. doi: 10.1289/EHP5621. Epub 2020 Feb 19.
PubMed 32073305
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals Among a Child-Bearing Age Cohort
- ClinicalTrials.gov ID
- NCT06450951
- Acronym / sponsor ID
- REED / 2R44ES034312-02
- Conditions
- Environmental Exposure
- Keywords
- phthalates, bisphenols, parabens, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,074 participants (actual)
- Lead sponsor
- Million Marker Wellness, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Renown Health, University of Nevada, Reno
- Study start
- 23 May 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Active comparator | Diagnostic Test: Urinary EDC metabolite testing, Behavioral: Educational curriculumThe 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. |
| Test Only | Active comparator | Diagnostic Test: Urinary EDC metabolite testingThe test-only arm includes EDC testing and report-back. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary EDC metabolite testingMail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone. | Diagnostic test | Educational Intervention, Test Only |
| Educational curriculumA self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum. | Behavioural | Educational Intervention |
Primary outcome
Changes in concentration of EDC metabolites after the intervention
Time frame: Pre and post intervention (three months in between measurements)
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone
Changes in score of Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.
Time frame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
This surveys assesses EDC-specific environmental health literacy, based on questions in a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) or 1 (never) to 5 (always). Responses will be reverse coded during analysis as needed so that higher numbers reflect positive outcomes (higher EDC-EHL).
4 secondary outcomes
Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.
Time frame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Changes in wellness after the intervention.
Time frame: Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)
Change in Blood Biomarkers
Time frame: Pre and post intervention (three months in between measurements)
Changes in exposures
Time frame: baseline, 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 29328875Hiatt RA, Brody JG. Environmental Determinants of Breast Cancer. Annu Rev Public Health. 2018 Apr 1;39:113-133. doi: 10.1146/annurev-publhealth-040617-014101. Epub 2018 Jan 12.
- Background: PubMed 27760374Heindel JJ, Blumberg B, Cave M, Machtinger R, Mantovani A, Mendez MA, Nadal A, Palanza P, Panzica G, Sargis R, Vandenberg LN, Vom Saal F. Metabolism disrupting chemicals and metabolic disorders. Reprod Toxicol. 2017 Mar;68:3-33. doi: 10.1016/j.reprotox.2016.10.001. Epub 2016 Oct 17.
- Background: PubMed 30400886Hwang S, Lim JE, Choi Y, Jee SH. Bisphenol A exposure and type 2 diabetes mellitus risk: a meta-analysis. BMC Endocr Disord. 2018 Nov 6;18(1):81. doi: 10.1186/s12902-018-0310-y.
- Background: PubMed 31376593Ghayda RA, Williams PL, Chavarro JE, Ford JB, Souter I, Calafat AM, Hauser R, Minguez-Alarcon L. Urinary bisphenol S concentrations: Potential predictors of and associations with semen quality parameters among men attending a fertility center. Environ Int. 2019 Oct;131:105050. doi: 10.1016/j.envint.2019.105050. Epub 2019 Jul 31.
- Background: PubMed 29161633Machtinger R, Gaskins AJ, Racowsky C, Mansur A, Adir M, Baccarelli AA, Calafat AM, Hauser R. Urinary concentrations of biomarkers of phthalates and phthalate alternatives and IVF outcomes. Environ Int. 2018 Feb;111:23-31. doi: 10.1016/j.envint.2017.11.011. Epub 2017 Nov 20.
- Background: PubMed 27765541Attina TM, Hauser R, Sathyanarayana S, Hunt PA, Bourguignon JP, Myers JP, DiGangi J, Zoeller RT, Trasande L. Exposure to endocrine-disrupting chemicals in the USA: a population-based disease burden and cost analysis. Lancet Diabetes Endocrinol. 2016 Dec;4(12):996-1003. doi: 10.1016/S2213-8587(16)30275-3. Epub 2016 Oct 17.
- Background: PubMed 27857130Braun JM. Early-life exposure to EDCs: role in childhood obesity and neurodevelopment. Nat Rev Endocrinol. 2017 Mar;13(3):161-173. doi: 10.1038/nrendo.2016.186. Epub 2016 Nov 18.
- Background: PubMed 32120140Mustieles V, Zhang Y, Yland J, Braun JM, Williams PL, Wylie BJ, Attaman JA, Ford JB, Azevedo A, Calafat AM, Hauser R, Messerlian C. Maternal and paternal preconception exposure to phenols and preterm birth. Environ Int. 2020 Apr;137:105523. doi: 10.1016/j.envint.2020.105523. Epub 2020 Feb 29.
- Background: PubMed 29078782Woods MM, Lanphear BP, Braun JM, McCandless LC. Gestational exposure to endocrine disrupting chemicals in relation to infant birth weight: a Bayesian analysis of the HOME Study. Environ Health. 2017 Oct 27;16(1):115. doi: 10.1186/s12940-017-0332-3.
- Background: PubMed 26406292Veiga-Lopez A, Kannan K, Liao C, Ye W, Domino SE, Padmanabhan V. Gender-Specific Effects on Gestational Length and Birth Weight by Early Pregnancy BPA Exposure. J Clin Endocrinol Metab. 2015 Nov;100(11):E1394-403. doi: 10.1210/jc.2015-1724. Epub 2015 Sep 25.
- Background: PubMed 30578470Raghavan R, Romano ME, Karagas MR, Penna FJ. Pharmacologic and Environmental Endocrine Disruptors in the Pathogenesis of Hypospadias: a Review. Curr Environ Health Rep. 2018 Dec;5(4):499-511. doi: 10.1007/s40572-018-0214-z.
- Background: PubMed 25445825Gascon M, Casas M, Morales E, Valvi D, Ballesteros-Gomez A, Luque N, Rubio S, Monfort N, Ventura R, Martinez D, Sunyer J, Vrijheid M. Prenatal exposure to bisphenol A and phthalates and childhood respiratory tract infections and allergy. J Allergy Clin Immunol. 2015 Feb;135(2):370-8. doi: 10.1016/j.jaci.2014.09.030. Epub 2014 Oct 30.
- Individual participant dataSharing planned: Yes. Million Marker will disseminate research results and findings to the scientific community through presentations at scientific meetings and conferences and publications in academic journals, as well as through the mass media and online postings. The Principal Investigator of this study will make data and associated documentation/metadata available to external researchers under a data-sharing agreement in which a specific commitment is made to use the data for research purposes only, to not provide the data to a third party or distribute it in any form, and to properly acknowledge the source of funding for the collection of the data and the researchers involved in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Kwaitkowski, PhD study director
Million Marker Wellness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary EDC metabolite testing and Educational curriculum in people with Environmental Exposure, run by Million Marker Wellness, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in concentration of EDC metabolites after the intervention (time frame: Pre and post intervention (three months in between measurements)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450951, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.