Early Tracking of Childhood Health Determinants (ETCHED) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Tracking of Childhood Health Determinants Study

Conditions
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Obesity, Diabetes Mellitus, Fatty Liver

Participation Criteria
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Eligibility Criteria
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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. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Women who are incarcerated or are unable to consent. Women whose fetus is not viable or are not planning to continue the pregnancy.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Children of mothers enrolled in the study | |
| Pregnant women and mothers<br>Pregnant women/mothers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant BMI | 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). | Birth, 6 weeks, and 4, 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child BMI | Child BMI measured annually from 2 years of age to 18 years of age | annually from age 2 to 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American Indians, Hispanics, Obesity, Pregnancy, Diabetes, Children, Hispanics, Natural History