Early Tracking of Childhood Health Determinants (ETCHED) Study
2 other identifiers
observational
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2041
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2041
May 12, 2026
May 8, 2026
19.7 years
March 28, 2018
May 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Child BMI
annually from age 2 to 18
Study Arms (2)
Children
Children of mothers enrolled in the study
Pregnant women and mothers
Pregnant women/mothers
Eligibility Criteria
Pregnant women from the Phoenix, AZ area
You may qualify if:
- 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. Mothers will also be eligible to participate with any consecutive pregnancies.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIDDK, Phoenix
Phoenix, Arizona, 85014, United States
Related Publications (4)
Pettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8. doi: 10.2337/diab.37.5.622.
PMID: 3360218BACKGROUNDDabelea D, Hanson RL, Lindsay RS, Pettitt DJ, Imperatore G, Gabir MM, Roumain J, Bennett PH, Knowler WC. Intrauterine exposure to diabetes conveys risks for type 2 diabetes and obesity: a study of discordant sibships. Diabetes. 2000 Dec;49(12):2208-11. doi: 10.2337/diabetes.49.12.2208.
PMID: 11118027BACKGROUNDPettitt DJ, Baird HR, Aleck KA, Bennett PH, Knowler WC. Excessive obesity in offspring of Pima Indian women with diabetes during pregnancy. N Engl J Med. 1983 Feb 3;308(5):242-5. doi: 10.1056/NEJM198302033080502.
PMID: 6848933BACKGROUNDArreola EV, Coonrod DV, Roy Choudhury S, Knowler WC, Hoskin M, Wasak D, Williams R, Hanson RL, Pack E, Caballero R, Gonzalez A, Sinha M. Study protocol for Early Tracking of Childhood Health determinants (ETCHED): A longitudinal observational life course study. BMC Public Health. 2024 Sep 29;24(1):2661. doi: 10.1186/s12889-024-20176-7.
PMID: 39343891DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madhumita Sinha, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2018
First Posted
March 29, 2018
Study Start
April 14, 2022
Primary Completion (Estimated)
December 31, 2041
Study Completion (Estimated)
December 31, 2041
Last Updated
May 12, 2026
Record last verified: 2026-05-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data from this study may be requested from other researchers 1 year after the completion of the primary endpoint by contacting the Principal Investigator.
- Access Criteria
- This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
This study will comply with the NIH Genomic Data Sharing Policy, which applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.