Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals in Adults of Child-Bearing Age

NCT05780047 | Completed Results DMC

• 1 other identifier: 1R43ES034312-01
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention study is to determine to what extent the Million Marker (MM) program reduces users' endocrine disruption chemical (EDC) exposure levels and changes their environmental health awareness and behaviors. The main questions it aims to answer are:

• Can the investigators see a reduction in EDC levels in participants' urine samples after using the MM Detect and Detox kit?
• Can the investigators see a change in participants' environmental health literacy, knowledge, and behaviors after using MM's products and services?
• How can Million Marker improve their app and platform to improve the user experience? Participants will collect their urine pre- and post-intervention, and will take a comprehensive exposure survey (via the MM app) before sending back their samples. This exposure survey will ask about participant's product use, diet, and lifestyle behaviors. Participants will also fill out surveys pre- and post-intervention assessing their perception of environmental health, as well as usability of the platform.

Conditions

Endocrine Disrupting Chemicals; Environmental Exposure; Health Literacy; Bisphenol A; Phthalate Exposure; Survey

Keywords

parabens; exposure; environment

Outcome Measures

Primary Outcomes (1)

• Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value.

  Urine samples collected pre- and post-intervention to measure changes in EDC levels

  Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention

Secondary Outcomes (1)

• Changes in Environmental Health Literacy Using the Environmental Literacy Survey

  Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention. Change scores are reported as the post-intervention subscale score minus the baseline score.

Study Arms (1)

Mobile EDC reduction program

EXPERIMENTAL

Million Marker's (MM) first-of-its-kind mobile endocrine disrupting chemical (EDC) reduction program will be tested and validated in a prospective longitudinal cohort intervention trial. 50 women in reproductive age and their partners will be recruited from the Healthy Nevada Project, an existing state-wide health monitoring effort. Using MM's services, participants' urine samples will be collected two times (at pre- and post-intervention) to measure changes in EDC levels. Changes in participants' environmental health literacy, attitudes, knowledge, and behaviors will be assessed after using MM's products and services. Validated surveys on environmental health literacy and readiness to change and analyses of participants' lifestyle behaviors and product use will be conducted at baseline (first test) and upon completion of the second test. The investigators will evaluate the MM app and platform usability to improve the user experience, using the System Usability Score (SUS) survey.

Diagnostic Test: Mail-in Urine Test for EDCs

Interventions

Mail-in Urine Test for EDCs DIAGNOSTIC_TEST

Million Marker provides a mail-in urine test for Bisphenol A (BPA) and phthalates. Users take a comprehensive exposure survey (via the MM app), send back their samples, view their personalized reports with tailored product recommendations, make changes to reduce their exposures, and retest to monitor their progress. Participants will also fill out surveys to assess changes in their environmental health literacy, readiness to change, and analyses of lifestyle behaviors and product use.

Also known as: Million Marker Detect and Detox test kit

Mobile EDC reduction program

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-40 years
• in good health, 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
• already consented for re-contact with the Healthy Nevada Project
• owning a smartphone
• willing to complete all study assessments

You may not qualify if:

• only one woman and her partner per household will be enrolled

Sponsors & Collaborators

• Million Marker Wellness, Inc.: lead

Study Sites (1)

Million Marker Wellness Inc.

Berkeley, California, 94704, United States

Location

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Limitations and Caveats

The lack of specificity and sensitivity in the EHL survey was a limitation of this study. The difficulty in assessing low levels of EDC metabolites was also a challenge, as the current EDC testing panel has high detection limits for some of the metabolites. The high attrition rate for the second urine test was also a problem, likely due to a long lag time without enough engagement and insufficient incentives.

Results Point of Contact

• Title: Carol Kwiatkowski, VP of Research
• Organization: Million Marker Wellness, Inc.

carol@millionmarker.com

510-305-5690

Study Officials

• Jenna Hua, PhD

  Million Marker Wellness, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 22, 2023
• Study Start: May 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 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)