Trial Outcomes & Findings for Personalized Mobile Intervention to Reduce Exposure to Endocrine Disrupting Chemicals in Adults of Child-Bearing Age (NCT NCT05780047)
NCT ID: NCT05780047
Last Updated: 2024-05-14
Results Overview
Urine samples collected pre- and post-intervention to measure changes in EDC levels
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
434 participants
Primary outcome timeframe
Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-intervention
Results posted on
2024-05-14
Participant Flow
Between August 2021 and July 2022, recruitment emails describing the study and asking for participation were sent to Healthy Nevada Project participants.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
434
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
384
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Did not submit baseline urine test kit
|
226
|
|
Overall Study
Lost to Follow-up
|
34
|
|
Overall Study
Did not submit second urine test kit
|
124
|
Baseline Characteristics
Two participants did not enter their age in the survey (missing data).
Baseline characteristics by cohort
| Measure |
Mobile EDC Reduction Program
n=434 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=434 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
434 Participants
n=434 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=434 Participants
|
|
Age, Continuous
|
30.7 years
n=434 Participants
|
|
Sex: Female, Male
Female
|
328 Participants
n=432 Participants • Two participants did not enter their age in the survey (missing data).
|
|
Sex: Female, Male
Male
|
104 Participants
n=432 Participants • Two participants did not enter their age in the survey (missing data).
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=434 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=434 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
44 Participants
n=434 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 Participants
n=434 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
7 Participants
n=434 Participants
|
|
Race/Ethnicity, Customized
White
|
344 Participants
n=434 Participants
|
|
Race/Ethnicity, Customized
Other
|
22 Participants
n=434 Participants
|
|
Region of Enrollment
United States
|
434 participants
n=434 Participants
|
|
Baseline metabolite concentrations
methyl paraben
|
69.48 ng/ml
STANDARD_DEVIATION 215.69 • n=191 Participants • Only 208 participants returned baseline urine test kits and 17 kits had errors in the lab analyses, resulting in 191 participants with baseline metabolite values.
|
|
Baseline metabolite concentrations
propyl paraben
|
22.86 ng/ml
STANDARD_DEVIATION 87.07 • n=191 Participants • Only 208 participants returned baseline urine test kits and 17 kits had errors in the lab analyses, resulting in 191 participants with baseline metabolite values.
|
|
Baseline metabolite concentrations
monobutyl phthalate
|
71.52 ng/ml
STANDARD_DEVIATION 105.73 • n=191 Participants • Only 208 participants returned baseline urine test kits and 17 kits had errors in the lab analyses, resulting in 191 participants with baseline metabolite values.
|
|
Baseline metabolite concentrations
monoethyl phthalate
|
151.60 ng/ml
STANDARD_DEVIATION 442.17 • n=191 Participants • Only 208 participants returned baseline urine test kits and 17 kits had errors in the lab analyses, resulting in 191 participants with baseline metabolite values.
|
|
Baseline metabolite concentrations
mono-(2-ethyl-5-carboxypentyl) phthalate
|
5.32 ng/ml
STANDARD_DEVIATION 17.88 • n=191 Participants • Only 208 participants returned baseline urine test kits and 17 kits had errors in the lab analyses, resulting in 191 participants with baseline metabolite values.
|
|
Environmental Health Literacy
Knowledge subscale
|
14.32 Scores on a Likert scale
STANDARD_DEVIATION 0.85 • n=433 Participants • 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. One participant had missing data for each of the knowledge and attitudes scales and 3 participants had missing data for the behaviors subscale.
|
|
Environmental Health Literacy
Attitudes subscale
|
13.03 Scores on a Likert scale
STANDARD_DEVIATION 1.54 • n=433 Participants • 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. One participant had missing data for each of the knowledge and attitudes scales and 3 participants had missing data for the behaviors subscale.
|
|
Environmental Health Literacy
Behaviors subscale
|
12.09 Scores on a Likert scale
STANDARD_DEVIATION 2.03 • n=431 Participants • 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. One participant had missing data for each of the knowledge and attitudes scales and 3 participants had missing data for the behaviors subscale.
|
PRIMARY outcome
Timeframe: Outcomes will be assessed at baseline (0-4 weeks) and up to 24 weeks for post-interventionPopulation: 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).
Urine samples collected pre- and post-intervention to measure changes in EDC levels
Outcome measures
| Measure |
Mobile EDC Reduction Program
n=55 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 556.90
|
|
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 20.50
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Mobile EDC Reduction Program
n=174 Participants
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.
|
|---|---|
|
Changes in Environmental Health Literacy Using the Environmental Literacy Survey
EHL Knowledge subscale
|
-0.16 units on a scale
Standard Deviation 1.13
|
|
Changes in Environmental Health Literacy Using the Environmental Literacy Survey
EHL attitudes subscale
|
-0.14 units on a scale
Standard Deviation 1.54
|
|
Changes in Environmental Health Literacy Using the Environmental Literacy Survey
EHL behaviors subscale
|
0.39 units on a scale
Standard Deviation 1.70
|
Adverse Events
Mobile EDC Reduction Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carol Kwiatkowski, VP of Research
Million Marker Wellness, Inc.
Phone: 510-305-5690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place