A Personalized Digital Intervention Program to Reduce Exposure to Endocrine Disrupting Chemicals among a Child-Bearing Age Cohort

个性化数字干预计划，以减少育龄人群接触内分泌干扰化学物质的机会

• 批准号: 10699889
• 负责人: Jenna Hua
• 金额: $ 102.83万
• 依托单位: MILLION MARKER WELLNESS INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699889
• 关键词: Address; Adult; Age; Analytical Chemistry; Asthma; Awareness; Back; Behavioral; Biological Markers; Biological Monitoring; Biometry; Businesses; Chemical Exposure; Chemicals; Chronic Disease; Clinic; Clinical; Counseling; Curriculum Management System; Data Engineering; Diabetes Mellitus; Disease; Economic Burden; Educational Curriculum; Endocrine Disruptors; Environmental Epidemiology; Environmental Exposure; Environmental Health; Exposure to; Female; Female of child bearing age; Fertility; Fetus; General Population; Genetic; Health; Hypersensitivity; Hypospadias; Individual; Infertility; Insurance Coverage; Intervention; Knowledge; Learning; Letters; Life Style; Link; Low Birth Weight Infant; Marketing; Measures; Metabolic syndrome; Mission; Modeling; Nevada; Outcome; Outcome Assessment; Parabens; Participant; Patient Recruitments; Patients; Personal Satisfaction; Persons; Phase; Population; Positioning Attribute; Precision Health; Predisposition; Pregnancy; Premature Birth; Process; Randomized; Randomized, Controlled Trials; Readiness; Reporting; Research; Sampling; Science; Scientist; Self Direction; Services; Surveys; System; Target Populations; Testing; Toxicology; Training; Urine; Vision; Well in self; Woman; Work; arm; chemical reduction; child bearing; clinical care; cohort; commercialization; compare effectiveness; cost effective; crowdsourcing; curriculum development; diabetes prevention program; digital; digital intervention; effectiveness testing; empowerment; environmental chemical; environmental chemical exposure; experience; genetic testing; global health; health literacy; healthy lifestyle; human centered design; improved; instrument; intervention program; literacy; male; malignant breast neoplasm; men; mobile application; multidisciplinary; online intervention; phase 1 study; phthalates; population health; post intervention; precision medicine; prevent; programs; public health relevance; recruit; reproductive; response; satisfaction; service intervention; testing services; tool; treatment arm; trend; usability

Project Summary/Abstract 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. Tools and services are urgently needed to allow individuals to learn about their personal EDC exposures and how to reduce them. Million Marker (MM) is a precision health company that was formed to fill this need. Our mission is 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 exposures and live a healthier lifestyle. Starting with a few biomarkers of common EDCs, our ultimate vision is to discover all possible (“a million”) biomarkers of EDC exposure to inform and improve individual health outcomes and advance precision medicine. MM is uniquely capable of carrying out this mission, with our team of multidisciplinary scientists who are highly trained in environmental epidemiology, toxicology, analytical chemistry, biostatistics, data engineering, and business. In Phase I of this study, we developed and tested the FIRST mobile EDC intervention service (app and exposure report-back) for its efficacy in increasing EH literacy (EHL), readiness to reduce exposures (i.e. readiness to change, RtC), and system usability among reproductive-age participants recruited from the Healthy Nevada Project (HNP), one of the largest population health cohorts in the world. We found a general trend of decreased EDC exposure with the intervention, as well as increased RtC. However, some participants did not increase their RtC and had difficulty carrying out the intervention on their own (which resulted in 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. Therefore, in this Phase II proposal, we 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). We plan to develop an EDC-specific online intervention curriculum (Aim 1); test the effectiveness of our intervention programs (Aim 2); and determine changes in EDC exposure before and after each intervention program (Aim 3). For Aim 1, we will recruit 15 men and 15 women of child-bearing age from HNP, our Phase I collaborator to participate in the intervention. For Aims 2 and 3, we will recruit and randomize 300 women and 300 men of reproductive age (total n=600) from HNP. Our target population is adult men and women of reproductive age (18-44 years old), who are also our target population (as stated in our Commercialization Plan). At the conclusion of this project, we will be well-positioned to begin Phase IIB and will scale our products and services to clinics and the general public, with the eventual aims of FDA approval, insurance coverage, and incorporation into routine clinical care.

项目总结/摘要 暴露于内分泌干扰化学品（EDCs）与慢性疾病有关， 包括乳腺癌、代谢综合征、糖尿病和不孕症。暴露的时间，特别是 在怀孕期间，可能会对胎儿产生终身影响。迫切需要工具和服务， 个人了解他们的个人EDC暴露以及如何减少它们。百万标记（MM）是一个 精准健康公司正是为了满足这一需求而成立的。 我们的使命是众包和规模化的环境化学品的生物监测，并提供 及时向消费者提供可操作的结果，以使个人能够主动评估， 跟踪，减少他们的暴露，过更健康的生活方式。从一些常见的生物标志物开始 EDC，我们的最终愿景是发现EDC暴露的所有可能的（“一百万”）生物标志物， 改善个人健康状况，推进精准医疗。MM是唯一能够执行 这项使命，与我们在环境流行病学方面训练有素的多学科科学家团队一起， 毒理学、分析化学、生物统计学、数据工程和商业。 在本研究的I期，我们开发并测试了FIRST移动的EDC干预服务（应用程序和 暴露报告），以评价其在提高EH素养（EHL）、准备减少暴露（即 准备改变，RtC），和系统的可用性之间的生殖年龄的参与者招募从 健康内华达州项目（HNP），世界上最大的人口健康队列之一。我们找到一个将军 干预后EDC暴露量呈下降趋势，RtC增加。然而，一些参与者 没有增加他们的RtC，并且很难自己进行干预（这导致没有 减少EDC暴露）。这些不太理想的结果的原因是在弹流学科的困难 参与者仍然觉得没有准备好将他们的知识应用于更健康的生活方式的改变。 因此，在第二阶段的提案中，我们将通过1）开发和2）测试来解决这些感知到的局限性 一个自我导向的在线互动课程与现场咨询会议和个性化的支持建模 在高效的糖尿病预防计划（DPP）和Omada Health（提供数字 交互式DPP）。 我们计划开发针对EDC的在线干预课程（目标1）;测试我们的 干预计划（目标2）;并确定每次干预前后EDC暴露的变化 方案（目标3）。对于目标1，我们将从国家警察招募15名育龄男子和15名育龄妇女， 合作者参与干预。对于目标2和3，我们将招募300名妇女并随机分组， 来自国家警察的300名育龄男子（共计600人）。我们的目标人群是成年男女， 生育年龄（18-44岁），也是我们的目标人群（如我们的商业化中所述 计划）。在该项目结束时，我们将做好准备，开始开始阶段IIB，并扩展我们的产品 以及为诊所和公众提供服务，最终目标是获得FDA批准，保险覆盖， 并纳入常规临床护理。