PregnancyNCT02273297
Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth
An observational study of Pregnancy and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- What is being tested?
- Maternal factors
- How many people
- 2,821 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2026
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants were recruited from prenatal obstetrics clinics at the University of Colorado Hospital outpatient pavilion.
Who may be able to join
- Pregnant women and infants
- Prior to 23 completed weeks of gestation
- Live in Colorado
Who cannot join
- Multiple gestation
- Preexisting
- cancer
- psychiatric disease
- steroid-dependent asthma, or
- diabetes
- Previous premature delivery prior to 25 weeks gestation or fetal demise
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Dana Dabelea, MD, PhD, 303-724-4414, dana.dabelea@ucdenver.edu
About this study
Official title: Exploring the Fuel-mediated Programming of Neonatal Growth
The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.
- Being tested
- Maternal factors
- Keywords
- Body composition, Body size
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal factorsOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women and their offspring | Ethnically diverse pregnant women and their offspring Receives: Other: Maternal factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
Measured: Birth
Fat mass
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
Measured: 5 years
Secondary outcomes (1)
Fat mass
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJul 2009
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
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 PregnancyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 2,821 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Dana Dabelea, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273297
- Sponsor's protocol ID
- 09-0563
- Other IDs
- R01DK076648, UL1TR001082
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2014
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Francis EC, Boyle KE, Gyllenhammer LE, Dabelea D, Jansson T, Perng W. Placental insulin-mTOR and stress-inflammatory signaling patterns are associated with childhood adiposity. BMC Med. 2026 May 8;24(1):370. doi: 10.1186/s12916-026-04896-8.
PubMed 42104380Buck KE, Dhaliwal SK, Dabelea D, Perng W. Association of maternal psychosocial stress with newborn body composition in the Healthy Start study. J Dev Orig Health Dis. 2023 Oct;14(5):576-583. doi: 10.1017/S2040174423000223. Epub 2023 Sep 11.
PubMed 37694587Dhaliwal SK, Dabelea D, Lee-Winn AE, Crume T, Wilkening G, Perng W. Maternal psychosocial stress during pregnancy and offspring neurobehavioral outcomes during early childhood in the Healthy Start Study. Ann Epidemiol. 2023 Oct;86:16-24.e3. doi: 10.1016/j.annepidem.2023.06.001. Epub 2023 Jun 14.
PubMed 37321280Cohen CC, Harrall KK, Gilley SP, Perng W, Sauder KA, Scherzinger A, Shankar K, Sundaram SS, Glueck DH, Dabelea D. Body composition trajectories from birth to 5 years and hepatic fat in early childhood. Am J Clin Nutr. 2022 Oct 6;116(4):1010-1018. doi: 10.1093/ajcn/nqac168.
PubMed 36055960Francis EC, Dabelea D, Boyle KE, Jansson T, Perng W. Maternal Diet Quality Is Associated with Placental Proteins in the Placental Insulin/Growth Factor, Environmental Stress, Inflammation, and mTOR Signaling Pathways: The Healthy Start ECHO Cohort. J Nutr. 2022 Mar 3;152(3):816-825. doi: 10.1093/jn/nxab403.
PubMed 34850052Moore BF, Sauder KA, Starling AP, Hebert JR, Shivappa N, Ringham BM, Glueck DH, Dabelea D. Proinflammatory Diets during Pregnancy and Neonatal Adiposity in the Healthy Start Study. J Pediatr. 2018 Apr;195:121-127.e2. doi: 10.1016/j.jpeds.2017.10.030. Epub 2017 Dec 6.
PubMed 29217099Perng W, Ringham BM, Glueck DH, Sauder KA, Starling AP, Belfort MB, Dabelea D. An observational cohort study of weight- and length-derived anthropometric indicators with body composition at birth and 5 mo: the Healthy Start study. Am J Clin Nutr. 2017 Aug;106(2):559-567. doi: 10.3945/ajcn.116.149617. Epub 2017 Jun 28.
PubMed 28659296Boyle KE, Patinkin ZW, Shapiro AL, Baker PR 2nd, Dabelea D, Friedman JE. Mesenchymal Stem Cells From Infants Born to Obese Mothers Exhibit Greater Potential for Adipogenesis: The Healthy Start BabyBUMP Project. Diabetes. 2016 Mar;65(3):647-59. doi: 10.2337/db15-0849. Epub 2015 Dec 2.
PubMed 26631736Starling AP, Brinton JT, Glueck DH, Shapiro AL, Harrod CS, Lynch AM, Siega-Riz AM, Dabelea D. Associations of maternal BMI and gestational weight gain with neonatal adiposity in the Healthy Start study. Am J Clin Nutr. 2015 Feb;101(2):302-9. doi: 10.3945/ajcn.114.094946. Epub 2014 Dec 3.
PubMed 25646327Crume TL, Shapiro AL, Brinton JT, Glueck DH, Martinez M, Kohn M, Harrod C, Friedman JE, Dabelea D. Maternal fuels and metabolic measures during pregnancy and neonatal body composition: the healthy start study. J Clin Endocrinol Metab. 2015 Apr;100(4):1672-80. doi: 10.1210/jc.2014-2949. Epub 2015 Jan 9.
PubMed 25574704
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Fuel-mediated Programming of Neonatal Growth
- ClinicalTrials.gov ID
- NCT02273297
- Acronym / sponsor ID
- 09-0563
- Keywords
- Body composition, Body size
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,821 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jul 2009
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- 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 purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women and their offspring | – | Other: Maternal factorsEthnically diverse pregnant women and their offspring |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were recruited from prenatal obstetrics clinics at the University of Colorado Hospital outpatient pavilion.
Key inclusion criteria (3 listed)
- Pregnant women and infants
- Prior to 23 completed weeks of gestation
- Live in Colorado
Key exclusion criteria (7 listed)
- Multiple gestation
- Preexisting
- Previous premature delivery prior to 25 weeks gestation or fetal demise
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 |
|---|---|---|
| Maternal factors | Other | Pregnant women and their offspring |
Primary outcome
Fat mass
Time frame: Birth
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
Fat mass
Time frame: 5 years
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
1 secondary outcome
Fat mass
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 42104380Francis EC, Boyle KE, Gyllenhammer LE, Dabelea D, Jansson T, Perng W. Placental insulin-mTOR and stress-inflammatory signaling patterns are associated with childhood adiposity. BMC Med. 2026 May 8;24(1):370. doi: 10.1186/s12916-026-04896-8.
- Derived from this study: PubMed 37694587Buck KE, Dhaliwal SK, Dabelea D, Perng W. Association of maternal psychosocial stress with newborn body composition in the Healthy Start study. J Dev Orig Health Dis. 2023 Oct;14(5):576-583. doi: 10.1017/S2040174423000223. Epub 2023 Sep 11.
- Derived from this study: PubMed 37321280Dhaliwal SK, Dabelea D, Lee-Winn AE, Crume T, Wilkening G, Perng W. Maternal psychosocial stress during pregnancy and offspring neurobehavioral outcomes during early childhood in the Healthy Start Study. Ann Epidemiol. 2023 Oct;86:16-24.e3. doi: 10.1016/j.annepidem.2023.06.001. Epub 2023 Jun 14.
- Derived from this study: PubMed 36055960Cohen CC, Harrall KK, Gilley SP, Perng W, Sauder KA, Scherzinger A, Shankar K, Sundaram SS, Glueck DH, Dabelea D. Body composition trajectories from birth to 5 years and hepatic fat in early childhood. Am J Clin Nutr. 2022 Oct 6;116(4):1010-1018. doi: 10.1093/ajcn/nqac168.
- Derived from this study: PubMed 34850052Francis EC, Dabelea D, Boyle KE, Jansson T, Perng W. Maternal Diet Quality Is Associated with Placental Proteins in the Placental Insulin/Growth Factor, Environmental Stress, Inflammation, and mTOR Signaling Pathways: The Healthy Start ECHO Cohort. J Nutr. 2022 Mar 3;152(3):816-825. doi: 10.1093/jn/nxab403.
- Derived from this study: PubMed 29217099Moore BF, Sauder KA, Starling AP, Hebert JR, Shivappa N, Ringham BM, Glueck DH, Dabelea D. Proinflammatory Diets during Pregnancy and Neonatal Adiposity in the Healthy Start Study. J Pediatr. 2018 Apr;195:121-127.e2. doi: 10.1016/j.jpeds.2017.10.030. Epub 2017 Dec 6.
- Derived from this study: PubMed 28659296Perng W, Ringham BM, Glueck DH, Sauder KA, Starling AP, Belfort MB, Dabelea D. An observational cohort study of weight- and length-derived anthropometric indicators with body composition at birth and 5 mo: the Healthy Start study. Am J Clin Nutr. 2017 Aug;106(2):559-567. doi: 10.3945/ajcn.116.149617. Epub 2017 Jun 28.
- Derived from this study: PubMed 26631736Boyle KE, Patinkin ZW, Shapiro AL, Baker PR 2nd, Dabelea D, Friedman JE. Mesenchymal Stem Cells From Infants Born to Obese Mothers Exhibit Greater Potential for Adipogenesis: The Healthy Start BabyBUMP Project. Diabetes. 2016 Mar;65(3):647-59. doi: 10.2337/db15-0849. Epub 2015 Dec 2.
- Derived from this study: PubMed 25646327Starling AP, Brinton JT, Glueck DH, Shapiro AL, Harrod CS, Lynch AM, Siega-Riz AM, Dabelea D. Associations of maternal BMI and gestational weight gain with neonatal adiposity in the Healthy Start study. Am J Clin Nutr. 2015 Feb;101(2):302-9. doi: 10.3945/ajcn.114.094946. Epub 2014 Dec 3.
- Derived from this study: PubMed 25574704Crume TL, Shapiro AL, Brinton JT, Glueck DH, Martinez M, Kohn M, Harrod C, Friedman JE, Dabelea D. Maternal fuels and metabolic measures during pregnancy and neonatal body composition: the healthy start study. J Clin Endocrinol Metab. 2015 Apr;100(4):1672-80. doi: 10.1210/jc.2014-2949. Epub 2015 Jan 9.
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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. This study is not recruiting at the moment.
Dana Dabelea, MD, PhD principal investigator
University of Colorado, Denver
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 Pregnancy and Obesity, run by University of Colorado, Denver 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Dabelea, MD, PhD (303-724-4414, Dana.Dabelea@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: Birth). The study lists 2 primary outcomes in all. 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 NCT02273297, 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 15 Mar 2024.