National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix Epidemiology and Clinical Research Branch (PECRB), 1550 E. Indian School Rd., Phoenix, AZ, 85014, USA.
Department of Obstetrics and Gynecology, Valleywise Health Medical Center, Phoenix, AZ, USA.
BMC Public Health. 2024 Sep 29;24(1):2661. doi: 10.1186/s12889-024-20176-7.
The prevalence of childhood obesity and diabetes continues to rise in the United States (US), especially among minority populations. The objective of the Early Tracking of Childhood Health Determinants (ETCHED) study is to investigate the role of adverse fetal and early-life risk exposures that contribute to the development of childhood obesity and metabolic risk.
ETCHED is a longitudinal observational study of American Indian/Alaska Native (AI/AN) and Hispanic pregnant woman and their offspring. Pregnant mothers ≥ 18 years old are enrolled at a large public hospital system in the southwestern US. Enrolled mothers are followed through pregnancy, delivery, and the maternal/offspring dyad will be followed until the child's 18th birthday. At each maternal visit, questionnaires assessing medical history, diet, physical activity, sleep, perceived stress, and socioeconomic and sociocultural information are obtained. Standard laboratory tests during maternal visits include glycemic measures, lipids, and renal function. Additional bio samples obtained include venous blood samples and cord blood for obesity/metabolic biomarkers and genetic/epigenetic testing, urinalysis, placental tissue for examining functional pathways, breast milk for metabolomics, and stool for metabolites and microbiome analysis. The offspring will have 6 infant/toddler visits at 6-12 weeks, 4 months, 6 months, 18 months, 2 and 3 years respectively. Thereafter, they will undergo comprehensive research visits (major visits) at 4-5 years, 6-9 years, 10-13 years, and 14-17 years. The major visits in children include detailed medical history, anthropometry, developmental assessment, socioeconomic and environmental assessments (food insecurity, family structure, and childcare), feeding and activity, biochemical tests, genetics/epigenetic testing, and ultrasound elastography. Electronic health records will be reviewed for additional clinical information. The primary analysis will constitute estimation of correlation coefficients between continuous variables. The planned study duration in this ongoing study is 23-years.
This is a life course study that that will examine biological and environmental risk factors for obesity and cardiometabolic risk from the intrauterine period to early childhood and adolescence in a population with high-risk of obesity and type 2 diabetes in the United States. The ETCHED study would also provide a unique opportunity to combine multi-omics and clinical data to create novel integrative models to predict the cardiometabolic risk associated with childhood obesity and possibly identify etiopathogenetic mechanisms and future targets of intervention.
ClinicalTrials.gov identifier: NCT03481829. Updated July 19, 2024, https://clinicaltrials.gov/study/NCT03481829?cond=ETCHED&rank=1 .
在美国（US），儿童肥胖症和糖尿病的患病率持续上升，尤其是在少数族裔人群中。早期追踪儿童健康决定因素（ETCHED）研究的目的是研究导致儿童肥胖和代谢风险的不良胎儿和早期生活风险暴露的作用。
ETCHED 是一项针对美国印第安人/阿拉斯加原住民（AI/AN）和西班牙裔孕妇及其后代的纵向观察研究。≥ 18 岁的孕妇在位于美国西南部的一家大型公立医院系统中被招募。入组的母亲会在怀孕期间、分娩期间和母婴对子中被跟踪，直到孩子 18 岁生日。在每次母婴就诊时，都会使用问卷评估病史、饮食、身体活动、睡眠、感知压力以及社会经济和社会文化信息。在母婴就诊期间进行的标准实验室检查包括血糖测量、血脂和肾功能。还获得了其他生物样本，包括静脉血样和脐带血，用于肥胖/代谢生物标志物和遗传/表观遗传检测、尿液分析、胎盘组织用于检查功能途径、母乳用于代谢组学以及粪便用于代谢物和微生物组分析。后代将在 6-12 周、4 个月、6 个月、18 个月、2 岁和 3 岁时分别进行 6 次婴儿/学步儿就诊。此后，他们将在 4-5 岁、6-9 岁、10-13 岁和 14-17 岁时进行全面的研究就诊（主要就诊）。主要就诊包括详细的病史、人体测量学、发育评估、社会经济和环境评估（粮食不安全、家庭结构和儿童保育）、喂养和活动、生化检查、遗传/表观遗传检查以及超声弹性成像。将审查电子健康记录以获取其他临床信息。该正在进行的研究的计划研究持续时间为 23 年。
这是一项生命周期研究，将从宫内期到儿童期和青春期，在肥胖症和 2 型糖尿病风险较高的人群中，检查肥胖和心脏代谢风险的生物和环境风险因素。ETCHED 研究还将提供一个独特的机会，将多组学和临床数据结合起来，创建新的综合模型来预测与儿童肥胖相关的心脏代谢风险，并可能确定发病机制和未来的干预靶点。
ClinicalTrials.gov 标识符：NCT03481829。更新于 2024 年 7 月 19 日，https://clinicaltrials.gov/study/NCT03481829?cond=ETCHED&rank=1。
