Bisphenol A, Endocrine Disrupting Chemicals, Environmental Exposure, Health Literacy, Phthalate Exposure, Survey
Conditions
Keywords
parabens, exposure, environment
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.
Detailed description
Exposures to endocrine disrupting chemicals (EDCs) have been linked to chronic diseases and conditions including breast cancer, metabolic syndrome, diabetes, and infertility. Timing of exposure, especially during pregnancy, may have a lifelong impact on the fetus, including neurodevelopmental problems and asthma. However, there have been no tools to allow those in the preconception, conception, and pregnancy stages to assess EDC exposures to ensure a healthy pregnancy and normal child development. Million Marker (MM) was born to fill this need. MM is a precision health company, built by a team of multidisciplinary scientists who are trained in environmental epidemiology, toxicology, analytical chemistry, biostatistics, data engineering, and business. MM's missions are to crowdsource and scale the biomonitoring of environmental chemicals and provide actionable results to consumers in a timely manner in order to empower individuals to proactively assess, track, and reduce their harmful environmental exposures. Starting with a few biomarkers of common EDCs, MM's ultimate vision is to discover all possible (a million) biomarkers of harmful exposures to inform and improve individual health outcomes and advance precision medicine. Less than a year after it was founded, Million Marker developed and sold the first product-a mail-in urine test for BPA and phthalates-and successfully helped users reduce exposures through personalized intervention plans. Customers are able to order a test kit online, receive the test kit via mail, take a comprehensive exposure survey (via the Million Marker app), send back samples via mail, view personalized reports with tailored product recommendations through a secure online portal, make lifestyle changes to reduce exposures, and retest to monitor progress. MM's initial target audience are individuals of reproductive age, due to the vulnerability pregnancy and preconception to EDC exposures. However, it is unclear to what extent the MM platform educates, motivates, and ultimately reduces EDC exposure in individuals in this age range. Therefore, the aims of the current proposal are to 1) test and validate a this first-of-its-kind mobile EDC reduction program in a prospective longitudinal cohort intervention trial; 2) assess changes in participants' environmental health literacy, attitudes, knowledge, and behaviors after using MM's products and services; and 3) evaluate the MM app and platform usability to improve the user experience. Validating this population with MM's program is a step towards these types of future studies. At the conclusion of the project, MM will be well-positioned to begin Phase II and will scale the EDCs testing and personalized intervention plan to fertility clinics and the general public.
Interventions
DIAGNOSTIC_TESTMail-in Urine Test for EDCs
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.
Sponsors
Million Marker Wellness, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* only one woman and her partner per household will be enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value. | Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention | Urine samples collected pre- and post-intervention to measure changes in EDC levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Validated survey on environmental health literacy will be conducted at baseline and upon completion of the second test. The surveys will be compared for changes. The EHL survey was adapted from the General Environmental Health Scale and was titled Environmental Health Literacy Scale with three subscales: knowledge, attitudes, and behaviors. Knowledge and attitude responses ranged from strongly disagree (1) to strongly agree (5) and behavior responses ranged from never (1) to always (5). Scores were summed across 3 questions within each subscale resulting in a range of 3 (worse) to 15 (better) for each subscale. |
Countries
United States
Participant flow
Recruitment details
Between August 2021 and July 2022, recruitment emails describing the study and asking for participation were sent to Healthy Nevada Project participants.
Participants by arm
| Arm | Count |
|---|---|
| Mobile EDC Reduction Program Million Marker's (MM) 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 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.
Mail-in Urine Test for EDCs: 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. | 434 |
| Total | 434 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not submit baseline urine test kit | 226 |
| Overall Study | Did not submit second urine test kit | 124 |
| Overall Study | Lost to Follow-up | 34 |
Baseline characteristics
| Characteristic | Mobile EDC Reduction Program |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 434 Participants |
| Age, Continuous | 30.7 years |
| Baseline metabolite concentrations methyl paraben | 69.48 ng/ml STANDARD_DEVIATION 215.69 |
| Baseline metabolite concentrations mono-(2-ethyl-5-carboxypentyl) phthalate | 5.32 ng/ml STANDARD_DEVIATION 17.88 |
| Baseline metabolite concentrations monobutyl phthalate | 71.52 ng/ml STANDARD_DEVIATION 105.73 |
| Baseline metabolite concentrations monoethyl phthalate | 151.60 ng/ml STANDARD_DEVIATION 442.17 |
| Baseline metabolite concentrations propyl paraben | 22.86 ng/ml STANDARD_DEVIATION 87.07 |
| Environmental Health Literacy Attitudes subscale | 13.03 Scores on a Likert scale STANDARD_DEVIATION 1.54 |
| Environmental Health Literacy Behaviors subscale | 12.09 Scores on a Likert scale STANDARD_DEVIATION 2.03 |
| Environmental Health Literacy Knowledge subscale | 14.32 Scores on a Likert scale STANDARD_DEVIATION 0.85 |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 44 Participants |
| Race/Ethnicity, Customized Native American | 3 Participants |
| Race/Ethnicity, Customized Other | 22 Participants |
| Race/Ethnicity, Customized Pacific Islander | 7 Participants |
| Race/Ethnicity, Customized White | 344 Participants |
| Region of Enrollment United States | 434 participants |
| Sex: Female, Male Female | 328 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 434 |
| other Total, other adverse events | 0 / 434 |
| serious Total, serious adverse events | 0 / 434 |
Outcome results
Primary
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
Time frame: Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention
Population: 55 participants returned valid baseline and post-intervention urine samples for analysis. Values shown were adjusted for specific gravity. 7 participants had missing data for one or more variables necessary for the analysis (baseline, follow-up or specific gravity).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile EDC Reduction Program | Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value. | methylparaben | 5.83 ng/ml | Standard Deviation 156.71 |
| Mobile EDC Reduction Program | Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value. | propylparaben | 18.43 ng/ml | Standard Deviation 105.85 |
| Mobile EDC Reduction Program | Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value. | monobutyl phthalate | 56.94 ng/ml | Standard Deviation 117.48 |
| Mobile EDC Reduction Program | Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value. | monoethyl phthalate | 75.30 ng/ml | Standard Deviation 556.9 |
| Mobile EDC Reduction Program | Changes in Endocrine Disrupting Chemical (EDC) Levels as Measured by the Post-intervention Value Minus the Baseline Value. | mono-(2-ethyl-5-carboxypentyl) phthalate | -3.47 ng/ml | Standard Deviation 20.5 |
p-value: <0.05t-test, 1 sided
Secondary
Changes in Environmental Health Literacy Using the Environmental Literacy Survey
Validated survey on environmental health literacy will be conducted at baseline and upon completion of the second test. The surveys will be compared for changes. The EHL survey was adapted from the General Environmental Health Scale and was titled Environmental Health Literacy Scale with three subscales: knowledge, attitudes, and behaviors. Knowledge and attitude responses ranged from strongly disagree (1) to strongly agree (5) and behavior responses ranged from never (1) to always (5). Scores were summed across 3 questions within each subscale resulting in a range of 3 (worse) to 15 (better) for each subscale.
Time frame: 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.
Population: For analysis of EHL questions, three subscales were created to assess knowledge, attitudes and behaviors related to EHL. Ordinal Likert scale responses were summed within the three subscales to create an approximately continuous variable for each, ranging from 3 (worse) to 15 (better). A positive change score reflecting higher post-intervention values is better. Two participants had missing data for the knowledge and attitude subscales and three had missing data for the behaviors subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile EDC Reduction Program | Changes in Environmental Health Literacy Using the Environmental Literacy Survey | EHL Knowledge subscale | -0.16 units on a scale | Standard Deviation 1.13 |
| Mobile EDC Reduction Program | Changes in Environmental Health Literacy Using the Environmental Literacy Survey | EHL attitudes subscale | -0.14 units on a scale | Standard Deviation 1.54 |
| Mobile EDC Reduction Program | Changes in Environmental Health Literacy Using the Environmental Literacy Survey | EHL behaviors subscale | 0.39 units on a scale | Standard Deviation 1.7 |
Comparison: Paired samples t-tests were run to compare whether EHL knowledge, attitudes and behavior changed after the intervention. EHL scores were expected to increase between pre and post testing.p-value: <0.05paired samples t-test