Obesity / Diabetes Mellitus / Fatty Liver · Observational Study

Early Tracking of Childhood Health Determinants (ETCHED) Study

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned prospective observational cohort study registered to enroll 1500 pregnant women (American Indian/Alaska Native or Hispanic) and follow their children from birth to age 18. The study will track maternal metabolic and lifestyle factors during pregnancy and measure infant growth (BMI) and child development outcomes over time, but no results are yet reported in this registry record.

What was studied

Observational. Diabetes Mellitus, Obesity, Fatty Liver; age from 1 Day; to 99 Years; accepts healthy volunteers. Intervention: Children; Pregnant women and mothers. n = 1,500. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

When results become available, this cohort study may identify prenatal and early-life risk factors for childhood obesity and metabolic disease in understudied high-risk populations; currently no clinical guidance can be drawn from this registry record.

Plain-language summary

This is a study registration describing an ongoing observational cohort with no results reported; it documents planned enrollment and follow-up design in a high-risk population but carries no outcome data.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Infant BMI (assessed at Birth, 6 weeks, and 4, 6, 12, 18 and 24 months)

DesignObservational

PopulationDiabetes Mellitus, Obesity, Fatty Liver; age from 1 Day; to 99 Years; accepts healthy volunteers

Sample size1,500

InterventionChildren; Pregnant women and mothers

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment1500

Primary outcome measureInfant BMI at birth, 6 weeks, and 4, 6, 12, 18, and 24 months

Follow-up durationFrom birth until child's 18th birthday

Clinical bottom line

Caveats

No results are reported in this registry record; study is actively recruiting.
Observational design without control group limits causal inference.
Primary outcome is BMI; long-term metabolic or health outcomes not yet measured or reported.
Follow-up to age 18 is planned but not yet complete; retention and adherence rates unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective observational cohort with repeated maternal and child assessments; no control arm.

Directness

moderate

Measures infant BMI and maternal risk factors directly; long-term child health outcomes not yet assessed.

Consistency

insufficient

No results reported; consistency cannot be assessed at registration stage.

Risk of bias

insufficient

Study is recruiting; no conduct, blinding, or outcome data available to assess bias.

Sample adequacy

moderate

Planned 1500 participants in high-risk populations (AI/AN, Hispanic); adequate for descriptive follow-up.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03481829). This is a study registration, not published results. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Diabetes Mellitus, Obesity, Fatty Liver. Primary outcome measures: Infant BMI , Birth, 6 weeks, and 4, 6, 12, 18 and 24 months. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityDiabetes MellitusFatty LiverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NCT03481829