Diabetes MellitusNCT03481829
Early Tracking of Childhood Health Determinants (ETCHED) Study
An observational study of Diabetes Mellitus and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity, Fatty Liver
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 31 Dec 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women from the Phoenix, AZ area
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NIDDK, Phoenix
Phoenix, Arizona, 85014
About this study
Official title: Early Tracking of Childhood Health Determinants Study
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.
Read more
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.
Read the detailed description
Study Description:
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.
Objectives:
Primary Objective: Primary Objective: To study the associations of maternal risk factors, including pre-pregnancy body mass index, gestational weight gain, and glycemia during pregnancy with offspring birth weight, length, and age/sex adjusted Body Mass Index (BMI) percentile and z-score up to 24-months of age.
Secondary Objectives:
- To study the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia with weight, adiposity, and physical growth patterns during childhood and adolescence (2 to 18 years of age).
- To study the role of maternal clinical, genetic, biochemical, lifestyle, and psychosocial factors during pregnancy in mediating the associations between maternal risk factors and birth weight of the offspring, and weight, adiposity, metabolic profile, and neurodevelopment during infancy, childhood and adolescence.
- To examine the role of family, socioeconomic, and environmental factors influencing child growth patterns, body composition and neurodevelopment in infancy and childhood.
- To assess the frequency of hepatic steatosis in children and its association with BMI and biochemical changes
- To examine the relationship between maternal risk factors, early childhood exposures and changes in gut microbiome during, infancy, childhood and adolescence.
- To study the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia and placental function, methylome, transcriptome, proteome and metabolome with weight, adiposity, and physical growth patterns during childhood and adolescence (2 to 18 years of age).
Endpoints:
Primary Endpoint: 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 Endpoints: BMI percentile and z-scores 2 years to 18 years, biochemical measures, stool microbiome, neurocognitive
development.
- Conditions
- Diabetes Mellitus, Obesity, Fatty Liver
- Keywords
- American Indians, Hispanics, Obesity, Pregnancy, Diabetes, Children, Hispanics, Natural History
- Medical subject headings
- Diabetes Mellitus, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Children of mothers enrolled in the study | |
| Pregnant women and mothers | Pregnant women/mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Birth, 6 weeks, and 4, 6, 12, 18 and 24 months
Secondary outcomes (1)
Child BMI
Child BMI measured annually from 2 years of age to 18 years of age
Measured: annually from age 2 to 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start14 Apr 2022
- Primary completion31 Dec 2041 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Madhumita Sinha, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481829
- Sponsor's protocol ID
- 999918071
- Other IDs
- 18-DK-N071
- Status last verified
- 27 Oct 2026
- First submitted
- 28 Mar 2018
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 3360218Dabelea 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.
PubMed 11118027Pettitt 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.
PubMed 6848933Arreola 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.
PubMed 39343891
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Tracking of Childhood Health Determinants Study
- ClinicalTrials.gov ID
- NCT03481829
- Acronym / sponsor ID
- 999918071
- Conditions
- Diabetes Mellitus, Obesity, Fatty Liver
- Keywords
- American Indians, Hispanics, Obesity, Pregnancy, Diabetes, Children, Hispanics, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 31 Dec 2041 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study Description:
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.
Objectives:
Primary Objective: Primary Objective: To study the associations of maternal risk factors, including pre-pregnancy body mass index, gestational weight gain, and glycemia during pregnancy with offspring birth weight, length, and age/sex adjusted Body Mass Index (BMI) percentile and z-score up to 24-months of age.
Secondary Objectives:
- To study the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia with weight, adiposity, and physical growth patterns during childhood and adolescence (2 to 18 years of age).
- To study the role of maternal clinical, genetic, biochemical, lifestyle, and psychosocial factors during pregnancy in mediating the associations between maternal risk factors and birth weight of the offspring, and weight, adiposity, metabolic profile, and neurodevelopment during infancy, childhood and adolescence.
- To examine the role of family, socioeconomic, and environmental factors influencing child growth patterns, body composition and neurodevelopment in infancy and childhood.
- To assess the frequency of hepatic steatosis in children and its association with BMI and biochemical changes
- To examine the relationship between maternal risk factors, early childhood exposures and changes in gut microbiome during, infancy, childhood and adolescence.
- To study the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia and placental function, methylome, transcriptome, proteome and metabolome with weight, adiposity, and physical growth patterns during childhood and adolescence (2 to 18 years of age).
Endpoints:
Primary Endpoint: 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 Endpoints: BMI percentile and z-scores 2 years to 18 years, biochemical measures, stool microbiome, neurocognitive
development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children of mothers enrolled in the study |
| Pregnant women and mothers | – | –Pregnant women/mothers |
Who may qualify
- Ages
- 1 day to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women from the Phoenix, AZ area
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infant BMI
Time frame: 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).
1 secondary outcome
Child BMI
Time frame: annually from age 2 to 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 3360218Pettitt 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.
- Background: PubMed 11118027Dabelea 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.
- Background: PubMed 6848933Pettitt 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.
- Derived from this study: PubMed 39343891Arreola 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madhumita Sinha, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Sinha, M.D. ((301) 451-6237, madhumita.sinha@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant BMI (time frame: Birth, 6 weeks, and 4, 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481829, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.