ObesityUpstate KIDSNCT03106493
Upstate New York Infant Development Screening Program
An observational study of Obesity and Blood Pressure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
The goal of the Upstate KIDS Study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity, Blood Pressure, Motor Delay
- What is being tested?
- None (observational)
- How many people
- 6,171 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2008to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Exposure enriched cohort as described: Buck Louis GM, Hediger ML, Bell EM, Kus CA, Sundaram R, McLain AC, Yeung E, Hills EA, Thoma ME, Druschel CM. Methodology for Establishing a Population-Based Birth Cohort Focusing on Couple Fertility and Children's Development, the Upstate KIDS Study. Paediatric and Perinatal Epidemiology. 2014 May;28(3):191-202.
Who may be able to join
- Mothers delivering a live birth in New York State (excluding New York City).
Who cannot join
- Refused follow-up
About this study
The goal of the Upstate KIDS Study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth.
Read the detailed description
The Upstate KIDS Study aims to determine if there are differences in health measures between children conceived by infertility treatment and children conceived naturally. In the first phase of the study, the focus was on growth and development through age 3 years. In the second phase of the study, the focus is turning to cardiometabolic factors through age 9 years. Infertility treatments include assisted reproductive technologies (ART) such as in vitro fertilization (IVF), controlled ovarian hyperstimulation (COH) and ovulation induction (OI). The study was originally designed as a matched exposure cohort. Specifically, singletons whose birth certificates indicated the use of infertility treatment were considered 'exposed' singleton infants and subsequently frequency-matched on perinatal region of birth at a ratio of 1:3 to 'unexposed' singletons. Twins and higher order multiples were invited to participate regardless of mode of conception. Mothers and their newborns were recruited approximately 2-4 months postpartum. The first phase of the study was completed in 2014 and main findings can be found under publications.
The second phase objectives are:
To determine whether infertility treatment is associated with differences in growth and development from age 6 to 8 years with particular focus on childhood cardio-metabolic outcomes by follow-up of children conceived by ART or other infertility treatments and children who were conceived without treatment. Secondarily, to assess epigenetic differences as measured by DNA methylation using collected biospecimens.
- Conditions
- Obesity, Blood Pressure, Motor Delay, Developmental Delay, Asthma, Allergies
- Being tested
- None (observational)
- Medical subject headings
- Obesity, Psychomotor Disorders, Learning Disabilities, Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (observational)Other
None (observational)
| Study group | Role | What they receive |
|---|---|---|
| Primary | Singletons and 1 twin of each pair Receives: Other: None (observational) | |
| Secondary | Twin sibling of children enrolled in primary cohort Receives: Other: None (observational) | |
| Tertiary | Higher order multiples and siblings Receives: Other: None (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measurement of blood pressure
Measured: Through age 9 years
Secondary outcomes (1)
Motor milestone development
Study collected information using questionnaires to mothers with aid of journal
Measured: 4-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Jul 2008
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 6,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- New York State Department of Health, University at Albany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106493
- Sponsor's protocol ID
- HHSN275201400013C
- Acronym
- Upstate KIDS
- Status last verified
- Mar 2021
- First submitted
- 4 Apr 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available for public use by NIH data sharing system.
Publications
Buck Louis GM, Hediger ML, Bell EM, Kus CA, Sundaram R, McLain AC, Yeung E, Hills EA, Thoma ME, Druschel CM. Methodology for establishing a population-based birth cohort focusing on couple fertility and children's development, the Upstate KIDS Study. Paediatr Perinat Epidemiol. 2014 May;28(3):191-202. doi: 10.1111/ppe.12121. Epub 2014 Mar 25.
PubMed 24665916Andersen NJ, Mondal TK, Preissler MT, Freed BM, Stockinger S, Bell E, Druschel C, Louis GM, Lawrence DA. Detection of immunoglobulin isotypes from dried blood spots. J Immunol Methods. 2014 Feb;404:24-32. doi: 10.1016/j.jim.2013.12.001. Epub 2013 Dec 13.
PubMed 24333851Buck Louis GM, Druschel C, Bell E, Stern JE, Luke B, McLain A, Sundaram R, Yeung E. Use of assisted reproductive technology treatment as reported by mothers in comparison with registry data: the Upstate KIDS Study. Fertil Steril. 2015 Jun;103(6):1461-8. doi: 10.1016/j.fertnstert.2015.02.033. Epub 2015 Mar 23.
PubMed 25813287Yeung EH, Sundaram R, Bell EM, Druschel C, Kus C, Ghassabian A, Bello S, Xie Y, Buck Louis GM. Examining Infertility Treatment and Early Childhood Development in the Upstate KIDS Study. JAMA Pediatr. 2016 Mar;170(3):251-8. doi: 10.1001/jamapediatrics.2015.4164.
PubMed 26746435Yeung EH, Sundaram R, Bell EM, Druschel C, Kus C, Xie Y, Buck Louis GM. Infertility treatment and children's longitudinal growth between birth and 3 years of age. Hum Reprod. 2016 Jul;31(7):1621-8. doi: 10.1093/humrep/dew106. Epub 2016 May 10.
PubMed 27165624Jankowski E, Putnick DL, Ghassabian A, Clayton PK, Lin TC, Yeung EH. Feeding problems in infancy and diet quality in later childhood: a prospective cohort study. Nutr J. 2026 May 18. doi: 10.1186/s12937-026-01311-z. Online ahead of print.
PubMed 42152104Clayton PK, Putnick DL, Trees IR, Robinson SL, O'Connor TG, Tyris JN, Yeung EH. Age of Juice Introduction and Cardiometabolic Outcomes in Middle Childhood. J Nutr. 2024 Aug;154(8):2514-2523. doi: 10.1016/j.tjnut.2024.06.014. Epub 2024 Jun 26.
PubMed 38936550Polinski KJ, Robinson SL, Putnick DL, Sundaram R, Ghassabian A, Joseph P, Gomez-Lobo V, Bell EM, Yeung EH. Maternal self-reported polycystic ovary syndrome with offspring and maternal cardiometabolic outcomes. Hum Reprod. 2024 Jan 5;39(1):232-239. doi: 10.1093/humrep/dead227.
PubMed 37935839Yeung EH, Mendola P, Sundaram R, Lin TC, Broadney MM, Putnick DL, Robinson SL, Polinski KJ, Wactawski-Wende J, Ghassabian A, O'Connor TG, Gore-Langton RE, Stern JE, Bell E. Conception by fertility treatment and cardiometabolic risk in middle childhood. Fertil Steril. 2022 Aug;118(2):349-359. doi: 10.1016/j.fertnstert.2022.04.030. Epub 2022 Jun 10.
PubMed 35697532Michels KA, Ghassabian A, Mumford SL, Sundaram R, Bell EM, Bello SC, Yeung EH. Breastfeeding and motor development in term and preterm infants in a longitudinal US cohort. Am J Clin Nutr. 2017 Dec;106(6):1456-1462. doi: 10.3945/ajcn.116.144279. Epub 2017 Nov 1.
PubMed 29092884
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upstate New York Infant Development Screening Program
- ClinicalTrials.gov ID
- NCT03106493
- Acronym / sponsor ID
- Upstate KIDS / HHSN275201400013C
- Conditions
- Obesity, Blood Pressure, Motor Delay, Developmental Delay, Asthma, Allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,171 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- New York State Department of Health, University at Albany
- Study start
- 1 Jul 2008 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 10 Apr 2017 (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.
The goal of the Upstate KIDS Study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth.
Detailed description
The Upstate KIDS Study aims to determine if there are differences in health measures between children conceived by infertility treatment and children conceived naturally. In the first phase of the study, the focus was on growth and development through age 3 years. In the second phase of the study, the focus is turning to cardiometabolic factors through age 9 years. Infertility treatments include assisted reproductive technologies (ART) such as in vitro fertilization (IVF), controlled ovarian hyperstimulation (COH) and ovulation induction (OI). The study was originally designed as a matched exposure cohort. Specifically, singletons whose birth certificates indicated the use of infertility treatment were considered 'exposed' singleton infants and subsequently frequency-matched on perinatal region of birth at a ratio of 1:3 to 'unexposed' singletons. Twins and higher order multiples were invited to participate regardless of mode of conception. Mothers and their newborns were recruited approximately 2-4 months postpartum. The first phase of the study was completed in 2014 and main findings can be found under publications.
The second phase objectives are:
To determine whether infertility treatment is associated with differences in growth and development from age 6 to 8 years with particular focus on childhood cardio-metabolic outcomes by follow-up of children conceived by ART or other infertility treatments and children who were conceived without treatment. Secondarily, to assess epigenetic differences as measured by DNA methylation using collected biospecimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Other: None (observational)Singletons and 1 twin of each pair |
| Secondary | – | Other: None (observational)Twin sibling of children enrolled in primary cohort |
| Tertiary | – | Other: None (observational)Higher order multiples and siblings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Exposure enriched cohort as described: Buck Louis GM, Hediger ML, Bell EM, Kus CA, Sundaram R, McLain AC, Yeung E, Hills EA, Thoma ME, Druschel CM. Methodology for Establishing a Population-Based Birth Cohort Focusing on Couple Fertility and Children's Development, the Upstate KIDS Study. Paediatric and Perinatal Epidemiology. 2014 May;28(3):191-202.
Key inclusion criteria (1 listed)
- Mothers delivering a live birth in New York State (excluding New York City).
Key exclusion criteria (1 listed)
- Refused follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (observational)None (observational) | Other | Primary, Secondary, Tertiary |
Primary outcome
Blood Pressure
Time frame: Through age 9 years
Measurement of blood pressure
1 secondary outcome
Motor milestone development
Time frame: 4-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 24665916Buck Louis GM, Hediger ML, Bell EM, Kus CA, Sundaram R, McLain AC, Yeung E, Hills EA, Thoma ME, Druschel CM. Methodology for establishing a population-based birth cohort focusing on couple fertility and children's development, the Upstate KIDS Study. Paediatr Perinat Epidemiol. 2014 May;28(3):191-202. doi: 10.1111/ppe.12121. Epub 2014 Mar 25.
- Background: PubMed 24333851Andersen NJ, Mondal TK, Preissler MT, Freed BM, Stockinger S, Bell E, Druschel C, Louis GM, Lawrence DA. Detection of immunoglobulin isotypes from dried blood spots. J Immunol Methods. 2014 Feb;404:24-32. doi: 10.1016/j.jim.2013.12.001. Epub 2013 Dec 13.
- Background: PubMed 25813287Buck Louis GM, Druschel C, Bell E, Stern JE, Luke B, McLain A, Sundaram R, Yeung E. Use of assisted reproductive technology treatment as reported by mothers in comparison with registry data: the Upstate KIDS Study. Fertil Steril. 2015 Jun;103(6):1461-8. doi: 10.1016/j.fertnstert.2015.02.033. Epub 2015 Mar 23.
- Background: PubMed 26746435Yeung EH, Sundaram R, Bell EM, Druschel C, Kus C, Ghassabian A, Bello S, Xie Y, Buck Louis GM. Examining Infertility Treatment and Early Childhood Development in the Upstate KIDS Study. JAMA Pediatr. 2016 Mar;170(3):251-8. doi: 10.1001/jamapediatrics.2015.4164.
- Background: PubMed 27165624Yeung EH, Sundaram R, Bell EM, Druschel C, Kus C, Xie Y, Buck Louis GM. Infertility treatment and children's longitudinal growth between birth and 3 years of age. Hum Reprod. 2016 Jul;31(7):1621-8. doi: 10.1093/humrep/dew106. Epub 2016 May 10.
- Derived from this study: PubMed 42152104Jankowski E, Putnick DL, Ghassabian A, Clayton PK, Lin TC, Yeung EH. Feeding problems in infancy and diet quality in later childhood: a prospective cohort study. Nutr J. 2026 May 18. doi: 10.1186/s12937-026-01311-z. Online ahead of print.
- Derived from this study: PubMed 38936550Clayton PK, Putnick DL, Trees IR, Robinson SL, O'Connor TG, Tyris JN, Yeung EH. Age of Juice Introduction and Cardiometabolic Outcomes in Middle Childhood. J Nutr. 2024 Aug;154(8):2514-2523. doi: 10.1016/j.tjnut.2024.06.014. Epub 2024 Jun 26.
- Derived from this study: PubMed 37935839Polinski KJ, Robinson SL, Putnick DL, Sundaram R, Ghassabian A, Joseph P, Gomez-Lobo V, Bell EM, Yeung EH. Maternal self-reported polycystic ovary syndrome with offspring and maternal cardiometabolic outcomes. Hum Reprod. 2024 Jan 5;39(1):232-239. doi: 10.1093/humrep/dead227.
- Derived from this study: PubMed 35697532Yeung EH, Mendola P, Sundaram R, Lin TC, Broadney MM, Putnick DL, Robinson SL, Polinski KJ, Wactawski-Wende J, Ghassabian A, O'Connor TG, Gore-Langton RE, Stern JE, Bell E. Conception by fertility treatment and cardiometabolic risk in middle childhood. Fertil Steril. 2022 Aug;118(2):349-359. doi: 10.1016/j.fertnstert.2022.04.030. Epub 2022 Jun 10.
- Derived from this study: PubMed 29092884Michels KA, Ghassabian A, Mumford SL, Sundaram R, Bell EM, Bello SC, Yeung EH. Breastfeeding and motor development in term and preterm infants in a longitudinal US cohort. Am J Clin Nutr. 2017 Dec;106(6):1456-1462. doi: 10.3945/ajcn.116.144279. Epub 2017 Nov 1.
- Individual participant dataSharing planned: Yes. Data will be made available for public use by NIH data sharing system.
Related trials for Obesity
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Blood Pressure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Through age 9 years). 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 NCT03106493, which also lists 10 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 3 Mar 2021.