RECRUITING

Early Tracking of Childhood Health Determinants (ETCHED) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Early Tracking of Childhood Health Determinants Study

Quick Facts

Study Start:2022-04-14
Study Completion:2041-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03481829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination)
  2. 2. American Indian or Hispanic by self-report
  3. 3. Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery.
  1. 1. Women who are incarcerated or are unable to consent.
  2. 2. Women whose fetus is not viable or are not planning to continue the pregnancy.

Contacts and Locations

Study Contact

Madhumita Sinha, M.D.
CONTACT
(602) 200-5307
madhumita.sinha@nih.gov

Principal Investigator

Madhumita Sinha, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

NIDDK, Phoenix
Phoenix, Arizona, 85014
United States

Collaborators and Investigators

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

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-14
Study Completion Date2041-12-31

Study Record Updates

Study Start Date2022-04-14
Study Completion Date2041-12-31

Terms related to this study

Keywords Provided by Researchers

  • American Indians, Hispanics
  • Obesity
  • Pregnancy
  • Diabetes
  • Children
  • Hispanics
  • Natural History

Additional Relevant MeSH Terms

  • Diabetes Mellitus
  • Obesity
  • Fatty Liver