Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450951
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-04
Brief Title:
A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals
Sponsor:
Million Marker Wellness Inc
Organization:
Million Marker Wellness Inc
Study Overview
Official Title:
A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals Among a Child-Bearing Age Cohort
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REED
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
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 ie 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 n600 Participants 11 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 MMs 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 ie 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 EHLRtC 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
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 ie 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 n600 Participants 11 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 MMs 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 ie 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 EHLRtC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None