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.

项目摘要/摘要 内分泌干​​扰化学物质（EDC）的暴露与慢性疾病有关 包括乳腺癌，代谢综合征，糖尿病和不育的疾病。暴露时间，尤其是 在怀孕期间，可能会对胎儿产生终生影响。迫切需要工具和服务以允许 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 为满足这一需求而成立的精密卫生公司。 我们的任务是众包和扩展环境化学品的生物监测并提供 及时向消费者采取可行的结果，以授权个人主动评估， 追踪并减少他们的曝光度，过着更健康的生活方式。从几个共同的生物标志物开始 EDCS，我们的最终愿景是发现EDC暴露的所有可能（“一百万”）生物标志物，以告知和 MM具有独特的能力 这项使命是我们的多学科科学家团队，他们在环境流行病学方面受过良好培训 毒理学，分析化学，生物统计学，数据工程和业务。 在本研究的第一阶段中，我们开发并测试了第一个移动EDC干预服务（APP和 曝光报告案）的提高EH识字率（EHL）的效率，准备减少暴露（即 准备更改，RTC）和从中招募的复制年龄参与者中的系统可用性 内华达州健康项目（HNP）是世界上最大的人口健康队列之一。我们找到了一般 EDC暴露于干预措施以及RTC增加的趋势。但是，一些参与者 没有增加他们的RTC，并且很难自行进行干预（这导致没有 减少EDC暴露）。这些最佳结果的原因是EHL受试者的困难 物质 - 参与者仍然不准备将知识应用于更健康的生活方式。 因此，在此II阶段提案中，我们将通过1）开发和测试来解决这些感知的局限 由实时咨询会议和个性化支持建模的自我指导的在线互动课程 在高效预防糖尿病计划（DPP）和OMADA健康之后（提供数字化 交互式DPP）。 我们计划开发EDC特定的在线干预课程（AIM 1）；测试我们的有效性 干预计划（目标2）；并确定每次干预之前和之后EDC暴露的变化 程序（AIM 3）。对于AIM 1，我们将从HNP招募15名男性和15名育龄的女性，我们的第一阶段 合作者参加干预。对于目标2和3，我们将招募和随机使300名妇女和 HNP的300名生殖年龄（总数n = 600）。我们的目标人口是成年男女 生殖年龄（18-44岁）也是我们的目标人群（如我们的商业化所述 计划）。在该项目的结论中，我们将有充分的位置开始IIB阶段，并将扩展我们的产品 以及为诊所和公众提供的服务，最终以FDA批准，保险范围的目的 并纳入常规临床护理中。