NCT03481829

Early Tracking of Childhood Health Determinants (ETCHED) Study

Recruiting now Last updated 8 April 2026

What this trial tests

trial in Diabetes Mellitus in 1,500 participants. Currently enrolling.

Timeline

14 April 2022

Primary endpoint
31 December 2041

31 December 2041

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,500
Start date	14 April 2022
Primary completion	31 December 2041
Estimated completion	31 December 2041
Sites	1 location across United States

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Obesity — all drugs for Obesity →
• Fatty Liver — all drugs for Fatty Liver →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 1 Day to 99, any sex, with Diabetes Mellitus or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Children s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during and after pregnancy, and how these affect a child s development. They will also follow the mother s health and well-being after pregnancy.

Objectives:

To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her child s growth and development from birth until adulthood.

Eligibility:

American Indian/Alaska Native (AI/AN) or Hispanic adult pregnant women and their offspring.

Design:

Mothers will have 3 visits during pregnancy.

In the child s first year, mothers will have 2 visits and their child will have 4.

Children will have 2 visits in their second year and 1 each year until they turn 18.

Mothers will have a visit 2 years after birth and 4-5 years later.

Both the mother and child s medical records will be reviewed. They will have physical exams and give blood and stool samples.

Mothers may give cord blood and placenta samples. They will give breastmilk and urine samples. They will fill out questionnaires.

They will have an ultrasound. They may get an activity monitor.

Mother and child will be followed until the child s 18th birthday.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association between gestational weight gain and metabolic and inflammatory biomarkers in the ETCHED cohort.
   RoyChoudhury S, Caballero R, Wasak D, Muller YL, et al · · 2026 · PMID 41741596 · DOI 10.1038/s41598-026-41560-w
2. Study protocol for Early Tracking of Childhood Health determinants (ETCHED): A longitudinal observational life course study.
   Arreola EV, Coonrod DV, Roy Choudhury S, Knowler WC, et al · · 2024 · PMID 39343891 · DOI 10.1186/s12889-024-20176-7