A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals

NCT06450951 | Active Not Recruiting DMC

• 1 other identifier: 2R44ES034312-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Exposure

Keywords

phthalates; bisphenols; parabens; behavior change

Outcome Measures

Primary Outcomes (1)

• Changes in EDC metabolites after the intervention

  Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone

  Pre and post intervention (three months in between measurements)

Secondary Outcomes (3)

• Changes in Endocrine Disrupting Chemical - Environmental Health Literacy (EDC-EHL) after the intervention.

  Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)

• Changes in 'Readiness to Change' to reduce risky behaviors after the intervention.

  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.

  Measured before the intervention, after the intervention (3 months after baseline), and at follow-up (3 months after the intervention)

Study Arms (2)

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.

Diagnostic Test: Urinary EDC metabolite testing; Behavioral: Educational curriculum

Test Only

ACTIVE COMPARATOR

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

Diagnostic Test: Urinary EDC metabolite testing

Interventions

Urinary EDC metabolite testing DIAGNOSTIC_TEST

Mail-in urine samples tested for metabolites of bisphenols, phthalates, parabens, and oxybenzone.

Educational Intervention; Test Only

Educational curriculum BEHAVIORAL

A self-directed online interactive curriculum of EDC material, with access to live coaches and an online forum.

Educational Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Renown Health: collaborator
• University of Nevada, Reno: collaborator
• Million Marker Wellness, Inc.: lead

Study Sites (1)

Renown Health

Reno, Nevada, 89557, United States

Location

Related Publications (18)

• 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.

  PMID: 29328875 BACKGROUND

• Heindel 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.

  PMID: 27760374 BACKGROUND

• Hwang 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.

  PMID: 30400886 BACKGROUND

• Ghayda 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.

  PMID: 31376593 BACKGROUND

• Machtinger 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.

  PMID: 29161633 BACKGROUND

• Attina 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.

  PMID: 27765541 BACKGROUND

• Braun 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.

  PMID: 27857130 BACKGROUND

• Mustieles 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.

  PMID: 32120140 BACKGROUND

• Woods 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.

  PMID: 29078782 BACKGROUND

• Veiga-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.

  PMID: 26406292 BACKGROUND

• Raghavan 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.

  PMID: 30578470 BACKGROUND

• Gascon 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.

  PMID: 25445825 BACKGROUND

• Paciencia 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.

  PMID: 30740706 BACKGROUND

• Kalkbrenner 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.

  PMID: 25199954 BACKGROUND

• Oulhote 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.

  PMID: 32073305 BACKGROUND

• Gutierrez-Torres DS, Barraza-Villarreal A, Hernandez-Cadena L, Escamilla-Nunez C, Romieu I. Prenatal Exposure to Endocrine Disruptors and Cardiometabolic Risk in Preschoolers: A Systematic Review Based on Cohort Studies. Ann Glob Health. 2018 Jul 27;84(2):239-249. doi: 10.29024/aogh.911.

  PMID: 30873814 BACKGROUND

• Ho V, Pelland-St-Pierre L, Gravel S, Bouchard MF, Verner MA, Labreche F. Endocrine disruptors: Challenges and future directions in epidemiologic research. Environ Res. 2022 Mar;204(Pt A):111969. doi: 10.1016/j.envres.2021.111969. Epub 2021 Aug 27.

  PMID: 34461123 BACKGROUND

• Rochester JR, Kwiatkowski CF, Neveux I, Dabe S, Hatcher KM, Lathrop MK, Daza EJ, Eskenazi B, Grzymski JJ, Hua J. A Personalized Intervention to Increase Environmental Health Literacy and Readiness to Change in a Northern Nevada Population: Effects of Environmental Chemical Exposure Report-Back. Int J Environ Res Public Health. 2024 Jul 11;21(7):905. doi: 10.3390/ijerph21070905.

  PMID: 39063482 BACKGROUND

Study Officials

• Carol Kwaitkowski, PhD

  Million Marker Wellness

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: May 23, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting six months after publication
• Access Criteria: Researchers must submit an acceptable research plan (goals of the proposed research, the specific hypotheses to be examined, justification for research and methods), be affiliated with a recognized research institution, have demonstrated expertise in the area of the proposed research project, and receive independent approval from their governing institutional review board. Data will be available for use only to answer the specific question(s) indicated in the research plan. The researchers must provide a list of variable names and an outline of how research findings will be disseminated; and will be asked to sign a data-sharing agreement that commits to: 1) not attempt to identify any individual participant, 2) secure the data using appropriate software technology, 3) and destroy or return all data once analyses are complete. All final datasets will be de-identified. Final authorship on manuscripts will require review and approval by the Principal Investigators of this study.

Locations

US (1)