Million Marker Wellness, Inc, Berkeley, California, USA.
University of Nevada, Reno, Reno, Nevada, USA.
Trials. 2024 Nov 25;25(1):793. doi: 10.1186/s13063-024-08627-3.
Exposures to endocrine disrupting chemicals (EDCs) have been linked to chronic diseases including breast cancer, metabolic syndrome, diabetes, and infertility. Exposure during pregnancy may have a lifelong impact on the fetus. Services are needed to allow individuals to learn about their personal EDC exposures and how to reduce them. Million Marker (MM) aims to crowdsource and scale the biomonitoring of environmental chemicals and provide actionable results to empower individuals to proactively assess, track, and reduce their EDC exposures. In previous research, we developed and tested the first mobile EDC intervention service (mail-in urine testing and exposure report-back) for its efficacy in increasing EH literacy (EHL), willingness to reduce exposures (i.e., readiness to change, RtC), and system usability. After intervention, we found increased EHL, increased RtC in women (but not men), and decreased EDC exposure. However, some participants did not increase their RtC and had difficulty carrying out the intervention on their own. 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 study, we will address these perceived limitations.
We will test a self-directed online interactive curriculum with live counseling sessions and individualized support modeled after the highly effective Diabetes Prevention Program (DPP). Recruiting from the Healthy Nevada Project (HNP), one of the largest population health cohorts in the world, we test the effectiveness of our EDC-specific online intervention curriculum via EHL and RtC surveys and determine changes in EDC exposure before and after intervention in a randomized controlled trial. We will also test for common clinical biomarkers via a commercially available at-home test (Siphox). We will recruit and randomize 300 women and 300 men of reproductive age (total n=600) from HNP. Our target population is men and women of reproductive age (18-44 years old).
At the conclusion of this project, we will be well-positioned to scale our services to clinics and the general public, with the eventual aims of FDA approval, insurance coverage, and incorporation into routine clinical care.
内分泌干扰物 (EDC) 的暴露与包括乳腺癌、代谢综合征、糖尿病和不育在内的慢性疾病有关。怀孕期间的暴露可能会对胎儿产生终身影响。需要提供服务，让个人了解自己的 EDC 暴露情况以及如何减少这些暴露。百万标记 (MM) 旨在众包和扩展环境化学物质的生物监测，并提供可行的结果，使个人能够主动评估、跟踪和减少 EDC 暴露。在之前的研究中，我们开发并测试了第一个移动 EDC 干预服务（邮寄尿液检测和暴露报告反馈），以评估其提高 EH 素养 (EHL)、减少暴露的意愿（即改变的准备程度，RtC）和系统可用性的效果。干预后，我们发现 EHL 增加了，女性的 RtC 增加了（但男性没有），EDC 暴露减少了。然而，一些参与者并没有增加他们的 RtC，并且自己进行干预有困难。这些不太理想的结果的原因是 EHL 主题的难度——参与者仍然觉得自己没有准备好将他们的知识应用于更健康的生活方式改变。因此，在这项研究中，我们将解决这些感知到的局限性。
我们将测试一种具有在线互动课程的自我指导式课程，该课程具有模拟高度有效的糖尿病预防计划 (DPP) 的现场咨询课程和个性化支持。我们将从世界上最大的人群健康队列之一的健康内华达州项目 (HNP) 招募参与者，通过 EHL 和 RtC 调查测试我们的 EDC 特定在线干预课程的有效性，并在随机对照试验中确定干预前后 EDC 暴露的变化。我们还将通过市售的家庭测试（Siphox）测试常见的临床生物标志物。我们将从 HNP 招募并随机分配 300 名育龄期女性和 300 名男性（总共 600 名）。我们的目标人群是育龄期（18-44 岁）的男性和女性。
在这个项目结束时，我们将做好充分准备，将我们的服务扩展到诊所和公众，最终目标是获得 FDA 批准、保险覆盖，并纳入常规临床护理。
