The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has launched the Early Tracking of Childhood Health Determinants (ETCHED) study, a longitudinal observational study aimed at understanding the early life factors that influence childhood health, particularly in high-risk populations. The study, which began enrolling participants in April 2022, plans to follow up to 750 mothers and their children from pregnancy until the child's 18th birthday, with a planned study duration of 23 years, completing in April 2045.
Study Design and Objectives
ETCHED is a single-site study conducted at Valleywise Health Medical Center (VHMC) in Phoenix, Arizona, focusing on pregnant women of American Indian/Alaska Native (AI/AN) or Hispanic race/ethnicity. The primary objective is to investigate the associations between maternal risk factors such as pre-pregnancy BMI, gestational weight gain, and glycemia with offspring's birth weight and adiposity during infancy (0-24 months of age).
Secondary objectives include:
- Studying the associations of maternal risk factors with weight, adiposity, and physical growth patterns during childhood and adolescence (2-18 years of age).
- Studying the role of maternal clinical, genetic, biochemical, lifestyle, and psychosocial factors during pregnancy in mediating the associations between maternal risk factors and birth weight of the offspring, and weight, adiposity metabolic profile, and neurodevelopment during infancy, childhood, and adolescence.
- Examining the role of family, socioeconomic, and environmental factors influencing child growth patterns, body composition and neurodevelopment in infancy and childhood.
- Assessing the frequency of hepatic steatosis in children and its association with BMI and biochemical alterations.
- Examining the relationship between maternal risk factors, early childhood exposures, and changes in gut microbiome during infancy, childhood, and adolescence.
- Studying the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia and placental function, methylome, transcriptome, proteome and metabolome with weight, adiposity, and physical growth patters during childhood and adolescence (2–18 years of age).
Data Collection and Analysis
Data collection involves in-person assessments, medical record reviews, phone interviews, and virtual media. Maternal data includes demographics, anthropometric measures, medical and obstetric history, laboratory evaluations, and biospecimens (blood, urine, stool, cord blood, placental tissue, and breast milk). Offspring data includes demographics, birth history, socioeconomic history, medical history, lifestyle habits, laboratory evaluations, and biospecimens (blood, urine, and stool). DNA and RNA data are collected on both mothers and offspring.
The study plans to analyze subgroups defined by race and ethnicity, given the participant demographics. Statistical analyses will include correlation coefficients between continuous variables and linear regression models to examine the roles of potential mediators on the relationship between maternal factors and offspring outcomes. Mixed effects models will be used to model changes in childhood BMI over time.
Ethical Considerations and Dissemination
The ETCHED study has been approved by the National Institutes of Health’s Institutional Review Board (NIH IRB) and complies with ethical principles for human subject research. Extensive community outreach was conducted in Hispanic and AI/AN communities prior to study initiation, including consultations with Tribal partners.
The results will be presented at conferences and published in peer-reviewed journals. Findings will also be shared with study participants, healthcare providers, and local Indigenous American communities in the southwestern US.
