Early Tracking of Childhood Health Determinants (ETCHED) Study

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
NCT03481829
Collaborator
(none)
1,500
Enrollment
1
Location
242.4
Anticipated Duration (Months)
6.2
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.

Children s hair and toenail clippings (and baby teeth that fall out, if possible) will be collected. 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 DiseaseIntervention/TreatmentPhase

    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
    Anticipated Study Start Date :
    Oct 20, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2041
    Anticipated Study Completion Date :
    Dec 31, 2041

    Arms and Interventions

    ArmIntervention/Treatment
    Children

    Children of mothers enrolled in the study

    Pregnant women and mothers

    Pregnant women/mothers

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

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

    1. Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination)

    2. American Indian or Hispanic by self-report

    3. Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery

    EXCLUSION CRITERIA:

    An individual who meets any of the following criteria will be excluded from participation in this study:

    1. Women who are incarcerated or are unable to consent.

    2. Women whose fetus is not viable or are not planning to continue the pregnancy.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1NIDDK, PhoenixPhoenixArizonaUnited States85014

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Madhumita Sinha, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    ClinicalTrials.gov Identifier:
    NCT03481829
    Other Study ID Numbers:
    • 999918071
    • 18-DK-N071
    First Posted:
    Mar 29, 2018
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Sep 7, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021