Early Tracking of Childhood Health Determinants (ETCHED) Study

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT03481829

Collaborator

(none)

1,500

Enrollment

Location

236.6

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Obesity Fatty Liver

Detailed Description

Approximately 50% of Pima Indian children from diabetic pregnancies develop T2DM by age 25. Since intrauterine exposure to diabetes leads to a higher risk of diabetes in the offspring, the risk might be greatly diminished by preventing diabetes during pregnancy or ameliorating its effects. Standard prenatal and obstetrical care has not been able to abolish this excess risk in the Pima Indians, which has remained unchanged from the 1940 s to the early 1990's.2 The risk of intrauterine exposures to diabetes in the mother and obesity has been shown to be strongly associated with youth onset type 2 diabetes in other populations including Hispanics. 3 The current project will establish a longitudinal cohort of mother/infant/child dyads among American Indian/Alaska Native (AI/AN) and Hispanic ethnic groups, to study the role of a combination of biological and environmental factors on infant/childhood obesity and cardio metabolic risk.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Tracking of Childhood Health Determinants Study

Actual Study Start Date :

Apr 14, 2022

Anticipated Primary Completion Date :

Dec 31, 2041

Anticipated Study Completion Date :

Dec 31, 2041

Arms and Interventions

Arm	Intervention/Treatment
Children Children of mothers enrolled in the study
Pregnant women and mothers Pregnant women/mothers

Outcome Measures

Primary Outcome Measures

Infant BMI [Birth, 6 weeks, and 4, 6, 12, 18 and 24 months]
Birth weight, length, and age/sex adjusted BMI percentile and z-score up to 24-months of age (time points: 6-12 weeks, 4, 6, 12, 18 and 24 months).

Secondary Outcome Measures

Child BMI [annually from age 2 to 18]
Child BMI measured annually from 2 years of age to 18 years of age

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination)
American Indian or Hispanic by self-report
Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery.

In case where a pregnant mother is carrying multiple fetuses (multiple pregnancy), she will be eligible to participate in this study and all her live newborns, as a result of that pregnancy, will be eligible for participation in this study.